Loading..

BioNTech Seeks Acquisitions

2022-08-08 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Ryan Richardson,Chief Strategy Officer said, "So we are looking at a wide range of opportunities. But for the most part, Matt, we're looking really at bolt-on acquisitions and/or strategic partnerships. Our focus is going to continue to be on organic R&D and scaling that up over the coming years. And as we get into more registrational trials with our own pipeline, we think we'll have a better ability, say, over the next 24 months or so, to be able to deploy capital into those pivotal trials that could deliver products for launches over the next 3 to 5 years, as Ugur laid out".

BioNTech Reiterates Revenue Guidance for the Full Year 2022

2022-08-08 10:00:00

BioNTech Reiterates revenue guidance for the full year 2022. The company estimated BioNTech COVID-19 vaccine revenues for the full 2022 financial year of €13 billion - €17 billion.

Genmab A/S and BioNTech SE Expand Global Strategic Collaboration to Develop and Commercialize Novel Immunotherapy Candidates

2022-08-05 10:45:00

Genmab A/S and BioNTech SE announced an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under the expansion, Genmab and BioNTech will jointly work to research, develop, and commercialize novel monospecific antibody candidates for various cancer indications. Since 2015, the companies have been working on the joint development of bispecific cancer antibodies aimed at improving immunotherapy options for cancer patients. Under the expanded collaboration, the companies will jointly develop and commercialize, subject to regulatory approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform. The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022. GEN1053/BNT313 is a CD27 antibody based on the HexaBody technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. Under the terms of the agreement, the companies will equally share the development costs and potential future profit deriving from GEN1053/BNT313. The companies currently have two jointly developed investigational medicines in clinical testing since 2019, fusing BioNTech’s proprietary immunomodulatory antibodies and Genmab’s DuoBody technology platform: GEN1046/BNT311 (DuoBody-PD-L1x4-1BB) is being evaluated in phase 1/2 clinical trials for the treatment of advanced solid tumors (NCT04937153, NCT03917381), and in a phase 2 study of patients with non-small cell lung cancer (NSCLC) (NCT05117242). GEN1042/BNT312 (DuoBody-CD40x4-1BB) is being evaluated for the treatment of patients with metastatic or locally advanced solid tumors in a phase 1/2 study (NCT04083599).

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy with Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

2022-07-27 10:45:00

Pfizer Inc. and BioNTech SE announced that the companies have initiated a randomized, active-controlled, observer-blind Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19. This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19. BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days prior to their first study visit. Participants will be stratified by the number of months since their last dose of COVID-19 vaccine received prior to entering the study (three to six months or more than six months). The study does not include a placebo (injection with no active ingredient). The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series: A 3-dose primary series to individuals 6 months through 4 years of age, a 2-dose primary series to individuals 5 years of age and older, and a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise. Booster Series: a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine, a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA), a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine, and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine. COMIRNATY® INDICATION: COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. COMIRNATY® is administered as a 2-dose primary series. COMIRNATY® AUTHORIZED USES: COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide: Primary Series: a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Booster Dose: a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®, a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine, and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Pfizer Inc. and BioNTech SE Submits Variation to the European Medicines Agency

2022-07-11 10:06:00

Pfizer Inc. and BioNTech SE submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children 6 months to less than 5 years of age (also referred to as 6 months through 4 years of age) with the 3- g dose of COMIRNATY (COVID-19 vaccine, mRNA) as a three dose series. The 3- g dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data. The submission included data from a Phase 2 3 randomized, controlled trial that included 4,526 children 6 monthsto less than 5 years of age. In the trial, children received the third 3- g dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months to less than 5 years were generally lower than in children 5 to less than 12 years of age. Pfizer and BioNTech submitted the same data to the U.S. Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3- g dose primary series in this age group in June 2022 The companies also plan to submit these data to other regulatory agencies around the world. COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age

2022-07-08 21:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) approved the companies' supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the U.S. under emergency use authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series. The approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30- g dose) elicited SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. In the trial, a two-dose primary series of the vaccine (30- g dose) was also 100% effective (95% confidence interval CI, 87.5, 100.0) in preventing COVID-19, measured between a week and more than four months after the second dose. During this time, all 30 cases of confirmed symptomatic COVID-19 were in the placebo group (n 1,109) and no cases were in the COMIRNATY group (n 1,119). The only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha as the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges. No cases of severe disease occurred in either the COMIRNATY or placebo group. The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow-up data after the second dose. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world. COMIRNATY is now the only COVID-19 vaccine approved by the FDA as a two-dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer-term follow-up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12-15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the U.S. FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA. COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

CureVac Files Patent Infringement Lawsuit in Germany Against BioNTech

2022-07-05 11:00:00

CureVac N.V. announced that it has moved to assert its intellectual property rights, accumulated over more than two decades of pioneering work in mRNA technology, which contributed to COVID-19 vaccine development. CureVac has filed a lawsuit in the German Regional Court in D-sseldorf against BioNTech SE and two of its subsidiaries, seeking fair compensation for infringement of a portfolio of CureVac's intellectual property rights, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, utilized in the manufacture and sale of Comirnaty-, BioNTech and Pfizer's mRNA COVID-19 vaccine. CureVac does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty- by BioNTech and its partner Pfizer. The CureVac intellectual property portfolio protects multiple inventions that are considered essential to the design and development of BioNTech's SARS CoV-2 mRNA vaccine, among others. These relate to the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expression, as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines.

Pfizer Inc. and BioNTech SE Announces New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine

2022-06-29 20:45:00

Pfizer Inc. and BioNTech SE announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year. The U.S. government will pay the companies $3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.

Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

2022-06-25 14:00:00

Pfizer Inc. and BioNTech SE announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine. The robust immune response was seen across two investigational dose levels, 30 µg and 60 µg. The Omicron adapted vaccine candidates (30 µg and 60 µg) studied in the Phase 2/3 trial in 1,234 participants 56 years of age and older elicited substantially higher neutralizing antibody responses against Omicron BA.1 when compared to the companies’ current COVID-19 vaccine. The pre-specified criterion for superiority was measured by the ratio of neutralizing geometric mean titers (GMR) with the lower bound of the 95% confidence interval >1. The geometric mean ratios (GMRs) for the monovalent 30 µg and 60 µg vaccines compared to the current COVID-19 vaccine were 2.23 (95% CI: 1.65, 3.00) and 3.15 (95% CI: 2.38, 4.16), respectively. The GMRs for the bivalent 30 µg and 60 µg vaccines compared to the current COVID-19 vaccine were 1.56 (95% CI: 1.17, 2.08) and 1.97 (95% CI: 1.45, 2.68), respectively. The monovalent Omicron-adapted vaccine 30 µg and 60 µg achieved a lower bound 95% confidence interval for GMR of >1.5, consistent with the regulatory requirement of super superiority. Demonstration of superiority against Omicron and safety are regulatory requirements for potential emergency use authorization of a variant-adapted vaccine. One month after administration, a booster dose of the Omicron-adapted monovalent candidates (30 µg and 60 µg) increased neutralizing geometric mean titers (GMT) against Omicron BA.1 13.5 and 19.6-fold above pre-booster dose levels, while a booster dose of the Omicron-adapted bivalent candidates conferred a 9.1 and 10.9-fold increase in neutralizing GMTs against Omicron BA.1. Both Omicron-adapted vaccine candidates were well-tolerated in participants who received one or the other Omicron-adapted vaccine. In a SARS-CoV-2 live virus neutralization assay tested on sera from participants over 56 years of age and older, sera efficiently neutralized BA.4/BA.5 with titers approximately 3-fold lower than BA.1. Pfizer and BioNTech will continue to collect additional study data on Omicron BA.4/BA.5 over the coming weeks. These results are being shared with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in advance of upcoming discussions with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28 and with the International Coalition of Medicines Regulatory Authorities (ICMRA) on June 30. The companies have also submitted additional data from their ongoing COVID-19 booster studies, including data on an additional dose of their current COVID-19 vaccine and Beta candidate, to further demonstrate the flexibility and potential benefit of mRNA-based vaccines. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series A 3-dose primary series to individuals 6 months through 4 years of age a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise Booster Series a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine Primary Series a 2-dose primary series to individuals 12 through 15 years of age a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise Booster Dose a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine Emergency Use Authorization Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

BioNTech SE Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer

2022-06-23 15:00:00

BioNTech SE announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech’s fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company’s proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate is currently being investigated in an ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors. The designation is based on positive preliminary Phase 1/2 data from the ongoing study that was presented at the AACR Annual Meeting in April 2022. The results demonstrated that treatment with CLDN6 CAR-T alone or in combination with CARVac was well tolerated and showed encouraging signs of anti-tumor activity in testicular cancer patients at the first evaluated dose levels. In the study all six patients with heavily pretreated testicular cancer eligible for efficacy analysis showed clinical benefits highlighting the potential of this novel approach. One patient achieved a complete response 18 weeks after infusion. Three patients achieved a partial response and showed deepening and durability of responses (one of them in the lowest CAR-T dose level cohort in combination with CARVac). One patient had stable disease with shrinkage of target lesions. The PRIME scheme is a regulatory mechanism introduced by the EMA that provides early and proactive support to developers of promising medicines, to optimize development plans and speed up evaluations so these medicines can reach patients faster. The goal is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need. Aiming to harness the power of cell therapies for solid cancers and to overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech`s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. The CARVac is based on BioNTech’s backbone-optimized uridine mRNA (uRNA)-lipoplex technology which through its inherent adjuvant function enables a potent T cell stimulation to improve persistence and functionality of the adoptively transferred CAR-T cells, thus enabling and maintaining a therapeutic effect even at low CAR-T doses. BNT211 is an investigational CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered by BioNTech founders and expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

BioNTech Starts Construction of First mRNA Vaccine Manufacturing Facility in Africa

2022-06-23 10:00:00

BioNTech SE has reached the next milestone in the establishment of scalable mRNA vaccine production in Africa on its planned schedule. Today, BioNTech welcomed its African partners for the first time on the African continent as construction works for the initial African mRNA manufacturing facility began in Kigali, Rwanda, with a target for the first set of manufacturing BioNTainers to be delivered to the site by the end of 2022. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries. The initial site will become a node in a decentralized and robust African end-to-end manufacturing network. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union. The Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers (one for the production of mRNA, and one for the production of the formulated bulk drug product). The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities. The estimated initial annual capacity of e. g. the Pfizer-BioNTech COVID-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after their installation.

BioNTech SE - Special Call

2022-06-20 15:30:00

To provide an update on BioNTech's clinical progress across its pipeline and provide a deep-dive on scientific and technology innovation from its proprietary research engine

Pfizer and BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

2022-06-17 13:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data. The EUA is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age. In the trial, children received the third3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following athird dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) one month after the third dose was 1,535.2 (95% CI, 1,388.2, 1,697.8) in children 2 through 4 years of age and 1,406.5 (95% CI, 1,211.3, 1,633.1) in infants 6 through 23 months. The antibody responses in both age groups were comparable to those recorded in people 16 to 25 years of age immunized with two 30-µg doses and met the pre-specified success criteria to declare non-inferiority. Demonstration of noninferiority and safety were the regulatory requirements for potential authorization of the Pfizer-BioNTech COVID-19 Vaccine in this age group. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine demonstrated a favorable safety and tolerability profile comparable to placebo. No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months through 4 years were generally lower than in children 5 through 11 years. In the 6 through 23 months age group, 30.3% of participants reported adverse events in the Pfizer-BioNTech COVID-19 Vaccine group, and 27.3% of participants reported adverse events in the placebo group. Similarly, 18.8% and 18.9% of participants who received the Pfizer-BioNTech COVID-19 Vaccine or placebo respectively reported adverse events in the 2 through 4-year age group. Reactogenicity events were mostly mild to moderate and short lived for both age groups with systemic events comparable to placebo. Reactions were comparable after dose 1, 2 and 3. The clinical trial results were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 15, who unanimously recommended authorization. The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet June 17 and June 18 to discuss a potential recommendation for the use and rollout of the vaccine to children 6 months through 4 years of age. Vaccinations for children 6 months through 4 years of age are anticipated to start subject to and after the CDC endorses the ACIP recommendation. Pfizer and BioNTech will begin shipping 3-µg pediatric doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines. The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency in early July. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

BioNTech SE - Special Call

2022-06-09 12:31:00

To provide an Update on Manufacturing and Development Plans of mRNA Vaccines in Africa

BioNTech SE Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM

2022-06-07 20:15:00

BioNTech SE Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM. Venue: Marriott Marquis, New York City, New York, United States.

BioNTech SE Announces Positive Phase 1 Data from MRNA-Based Individualized Neoantigen Specific Immunotherapy in Patients with Resected Pancreatic Cancer Presented At ASCO

2022-06-05 16:30:00

BioNTech SE announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC). Feasibility of the process of profiling each patient’s tumor to inform individualized vaccine design and on-demand manufacturing of iNeST in a clinically relevant timeframe was confirmed. The preliminary results showed a favorable safety profile as well as encouraging signs of clinical activity. The data have been presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting 2022 by Vinod Balachandran, M.D., at Memorial Sloan Kettering Cancer Center. Autogene cevumeran is the lead candidate from BioNTech’s iNeST platform, which is jointly developed together with Genentech, a member of the Roche Group, in multiple solid tumor indications. The data presented at the ASCO Annual Meeting include a total of 19 patients who underwent surgery and received atezolizumab. 16 out of these 19 patients (84%) received autogene cevumeran at 9.4 weeks (median; 95% CI 9–10) after surgery. The preliminary data readout from these 16 vaccinated patients revealed that autogene cevumeran in combination with atezolizumab was well-tolerated. Only 1 of 16 patients (6%) developed a vaccine-related Grade 3 fever and hypertension, no other Grade 3 or higher adverse events were observed. In addition, the treatment induced de-novo, neoantigen-specific T cell response in half (8/16) of these patients from undetectable levels to large fractions of all blood T cells (median 2.9%). At an early median follow-up of 18 months, patients with de-novo immune response (n=8) had a significantly longer recurrence-free survival (RFS) as compared to those without vaccine-induced immune responses (n=8) (median not reached vs. 13.4 months, HR 0.08, 95% CI 0.01-0.4, P = 0.003). Based on these data, BioNTech and Genentech are planning a randomized study to further evaluate the efficacy and safety of autogene cevumeran in combination with atezolizumab and chemotherapy in patients with resected PDAC. The investigator-initiated, single-center, Phase 1 trial (NCT04161755) was designed to evaluate the treatment of the companies’ individualized immunotherapy candidate autogene cevumeran in combination with the anti-PDL-1 immune checkpoint inhibitor atezolizumab as an add-on to the standard-of-care regimen with adjuvant chemotherapy mFOLFIRINOX in patients with resected PDACs. The primary objective of the study is to assess the safety. Secondary objectives include the efficacy of the treatment measured as the 18-month RFS, the immunogenicity as well as the feasibility of the treatment regimen. BioNTech’s iNeST platform previously demonstrated encouraging results with a tolerable safety profile of autogene cevumeran as single agent and in combination with atezolizumab in a heterogenous patient population with advanced and heavily pretreated solid tumors. In a Phase1a/b trial autogene cevumeran revealed robust CD8+ and CD4+ T cell responses and a manageable safety profile (NCT03289962). In October 2021, BioNTech announced that the first patient was dosed in a randomized Phase 2 trial (NCT04813627) of autogene cevumeran in the adjuvant treatment of post-operative circulating tumor DNA (ctDNA) positive, surgically resected colorectal cancer. BioNTech and Genentech are also conducting a Phase II proof-of-concept study, which is designed to evaluate autogene cevumeran plus pembrolizumab in the first-line treatment of advanced melanoma (NCT03815058).

BioNTech SE Approves Board Appointments

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl as supervisory board members. Prof. Dr. Anja Morawietz is Professor of External Accounting and General Business Administration at the Nuremberg University of Applied Sciences Georg Simon Ohm. She has in-depth expertise in accounting and auditing. In her research, she covers financial and sustainability reporting as well as developments in corporate governance. Prof. Dr. Rudolf Staudigl is an independent consultant and member of the Supervisory Board of TÜV Süd AG. He has extensive knowledge of production, science, and international markets, with a focus on China and India. He also has a deep understanding of biotechnology products having served for many years as Chairman of the Board of Directors of Wacker Chemie AG.

BioNTech SE Approves Special Cash Dividend

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved special cash dividend of EUR 2.00 per ordinary share (including those held in the form of ADSs).

BioNTech SE Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 02:00 PM

2022-05-31 14:08:00

BioNTech SE Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 02:00 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose

2022-05-23 10:45:00

Pfizer Inc. and BioNTech SE announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available. In the Phase 2/3 trial, 1,678 children received a third dose of the 3-µg formulation at least two months after the second dose at a time when Omicron was the predominant variant. The immunogenicity analysis of geometric mean titer (GMT) ratio and seroresponse rate was conducted on a subset of study participants one month following the third dose in children 6 months to under 5 years of age, compared to the second dose in the 16- to 25-year-old population. Non-inferiority was met for both the 6- to 24-month-old population and the 2- to under 5-year-old population for both co-primary endpoints. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was well-tolerated in this age group, and no new safety signals were identified. The majority of adverse events were mild or moderate. Studies in adults, adolescents, and children over 5 years of age continue to indicate that three doses of the Pfizer-BioNTech COVID-19 Vaccine enhances protection compared to two doses. The safety, immunogenicity and vaccine efficacy data for three doses of the vaccine in children under 5 years of age are consistent with the data seen in adults, suggesting that a third dose will provide similar benefit in children. In February 2022, the companies initiated a rolling submission for Emergency Use Authorization (EUA) of their COVID-19 vaccine in children 6 months to under 5 years of age, following a request by the U.S. Food and Drug Administration (FDA). At that time, a two-dose series was determined to be well-tolerated in this age group. Pfizer and BioNTech plan to submit these new safety, immunogenicity, and vaccine efficacy data on three doses to the rolling U.S. EUA application this week, with submissions to regulators worldwide to follow. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. The trial evaluated the safety, tolerability, and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

BioNTech SE and Pfizer Inc. Announces the U.S. Food and Drug Administration Expands Emergency Use Authorization

2022-05-17 21:14:00

On May 17, 2022, BioNTech SE and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.

Pfizer and BioNTech SE Granted U.S. Emergency Use Authorization for Booster Dose of Their Covid-19 Vaccine in Children 5 Through 11 Years of Age

2022-05-17 15:40:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. To date, more than 8 million5- to 11-year-olds in the U.S. have completed primary series. The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed. The third dose was well tolerated, with a safety profile similar to the two-dose primary series. This Phase 2/3 data builds on efficacy data for the primary two-dose series which showed 90.7% efficacy in children 5 through 11 without prior SARS-CoV-2 infection, measured from 7 days after the second dose, at a period when Delta was the prevalent strain. The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 Vaccine is the only COVID-19 vaccine authorized for use in the U.S. for children 5 through 11 years of age. The Phase 1/2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of a3-µg formulation of the Pfizer-BioNTech COVID-19 Vaccine on a three-dose schedule in children ages 6 months through 4 years (also known as under 5) is ongoing. Initial data is expected in the coming weeks.

Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement with European Commission

2022-05-16 11:49:00

Pfizer Inc. and BioNTech SE announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine. This amendment rephases planned deliveries to help support the European Commission and Member States' ongoing immunization programs, and is aligned to the companies' commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022. The companies' full-year 2022 revenue guidance and the full-year commitment of doses to be delivered to EC Member States in 2022 remain unchanged. Pfizer and BioNTech continue to evaluate potential adapted vaccines, including variant-based vaccines. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide. Primary Series a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise.

BioNTech SE Presents at 8th Annual Immuno-Oncology Innovation Forum, May-25-2022 01:10 PM

2022-05-11 14:52:00

BioNTech SE Presents at 8th Annual Immuno-Oncology Innovation Forum, May-25-2022 01:10 PM.

BioNTech SE Proposes Special Cash Dividend

2022-05-09 10:01:00

The management board and supervisory board of BioNTech SE have proposed a special cash dividend of €2.00 per ordinary share (including those held in the form of ADSs), which corresponds to an aggregate of approximately €486.0 million, based on the number of ordinary shares and ADSs outstanding as of April 30, 2022, pending approval at the Annual General Meeting to be held in June 2022, which the company expects to serve as the record date for the dividend.

BioNTech SE Reiterates Earnings Guidance for the Year 2022

2022-05-09 10:01:00

BioNTech SE reiterated earnings guidance for the year 2022. The company reiterates its prior 2022 financial year outlook.

Tranche Update on BioNTech SE (NasdaqGS:BNTX)'s Equity Buyback Plan announced on March 31, 2022.

2022-05-09 07:06:00

From March 31, 2022 to March 31, 2022, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for $0 million under the buyback announced on March 31, 2022.

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

2022-04-27 00:00:00

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

BioNTech SE and Pfizer Inc. Submits Application to U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of A 10- G Booster Dose

2022-04-26 21:11:00

On April 26, 2022, BioNTech SE and Pfizer Inc. submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10- g booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2 3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10- g two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals. The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

BioNTech SE Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022

2022-04-23 17:57:00

BioNTech SE Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022 . Venue: Boston, Massachusetts, United States. Speakers: Andreas Kuhn, Vice President RNA Biochemistry & Manufacturing, Jesse Dong, Vice President, Peptide Chemistry, Ugur Sahin, Co-Founder, CEO & Member of Management Board.

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022

2022-04-23 07:45:00

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022. Venue: Boston, Massachusetts, United States.

Biontech Se Proposes Amendment to Its Articles of Association

2022-04-21 10:07:00

Currently, the Supervisory Board consists of four members according to Sec. 9 para. 1 of the Articles of Association of the Biontech Se. The number of Supervisory Board members shall be increased to six in the future. This expansion takes into account the continuing growth of the Company and opens up the possibility of gaining additional expertise for the work of the Supervisory Board. The two additional seats on the Supervisory Board are to be filled by the election of two additional Supervisory Board members proposed under agenda item 8 of the Annual General Meeting.

BioNTech SE - Shareholder/Analyst Call

2022-04-21 10:07:00

Annual General Meeting

BioNTech SE Presents at 5th European Neoantigen Summit 2022, Apr-27-2022 05:00 PM

2022-04-15 10:08:00

BioNTech SE Presents at 5th European Neoantigen Summit 2022, Apr-27-2022 05:00 PM. Venue: Amsterdam, Netherlands. Speakers: Heinrich Haas, Vice President Formulation and Drug Development.

Pfizer Inc. and BioNTech SE Announce Data Demonstrating High Immune Response Following Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age

2022-04-14 10:46:00

Pfizer Inc. and BioNTech SE announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. These data demonstrate an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine compared to two doses. These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group. In the Phase 2/3 clinical trial, data were analyzed from 140 children 5 through 11 years of age received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 vaccine 10-µg primary series. Data from a sub analysis of 30 sera from this study indicate that serum antibodies induced by a third dose neutralize the SARS-CoV-2 Omicron variant in this age group, as demonstrated by a 36-fold increase in neutralizing antibody titers compared to levels seen after two doses of the Pfizer-BioNTech COVID-19 Vaccine. A robust response was observed regardless of prior SARS-CoV-2 infection. Further, immunogenicity data from 140 participants in the Phase 2/3 clinical trial with who had no evidence of prior SARS-CoV-2 infection showed a 6-fold increase (95% CI: 5.0, 7.6) in SARS-CoV-2 wild-type strain–neutralizing geometric mean titers (GMTs) one month after the booster compared to the SARS-CoV-2–neutralizing GMTs one month after the second dose of the Pfizer-BioNTech COVID-19 vaccine, demonstrating a strong immune response in this age group. To date, more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech COVID-19 vaccine, and in this most recent booster data readout (n=401), the vaccine was well tolerated with no new safety signals observed. Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose for children ages 5 through 11 in the U.S. in the coming days. The companies also plan to share these data with the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible. A primary series of two 10-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA for this age group in October 2021. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. About the Phase 1/2/3 Trial in Children - The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age. To evaluate the effectiveness of a third 10-µg dose in children 5 through 11 years of age, Pfizer and BioNTech tested a panel of 30 human immune sera obtained from the blood of individuals that received two or three 10-µg doses of the current Pfizer-BioNTech COVID-19 Vaccine, using a live SARS-CoV-2 recombinant virus fluorescent foci reduction neutralization test (FFRNT). Each serum was tested simultaneously for its neutralizing titer against recombinant SARS-CoV-2 (with USA-WA-1/2020 genetic backbone) bearing the wild-type SARS-CoV-2 spike protein and theOmicron spike. The 50% neutralizing geometric mean titer (GMT) against Omicron was 993 (after three doses), compared to 27 after two doses. The neutralizing GMT against the wild-type virus was 2153 (after three doses), compared to 335 after two doses. Further analysis will assess the persistence of neutralizing titers over time after a booster dose of the Pfizer-BioNTech COVID-19 Vaccine against the Omicron and wild-type strains. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series - a 2-dose primary series to individuals 5 years of age and older; and a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise. Booster Series - a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA); a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series; a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

BioNTech SE announced that it has received $149.999985 million in funding from Pfizer Inc.

2022-04-14 00:00:00

On April 14, 2022, BioNTech SE closed the transaction. The company received $149,999,985 in the transaction. The transaction included participation from 1 investor.

BioNTech and Matinas BioPharma Announce Exclusive Research Collaboration to Evaluate Novel Delivery Technology for mRNA-based Vaccines

2022-04-11 11:00:00

BioNTech SE and Matinas BioPharma announced that they have entered into an exclusive research collaboration to evaluate the combination of mRNA formats and Matinas’ proprietary LNC platform technology. The parties will closely collaborate on formulation, optimization, and in vitro testing. Under the terms of the agreement, Matinas will receive an upfront access fee to work exclusively with BioNTech, as well as additional research funding from BioNTech. The parties have also commenced discussions on a license agreement for Matinas’ LNC platform technology.

BioNTech Presents Positive Preliminary Phase 1/2 Data for First-In-Class CAR-T Program BNT211 at AACR

2022-04-11 07:55:00

BioNTech SE presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. The preliminary results demonstrated an encouraging safety profile and anti-tumor activity in testicular cancer patients at the first evaluated dose levels of BNT211. The presentation included data from 16 patients who received CLDN6 CAR-T cells at dose levels 1 (1x107 CAR-T cells) and 2 (1x108 CAR-T cells) alone or combined with CARVac. Tumor indications included testicular cancer (n=8) ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. All 16 patients showed robust CAR-T cell expansion 10-17 days after infusion with cell frequencies close to 109 total counts in dose level 2. Adverse events and dose limiting toxicities were manageable; cytokine release syndromes of grade 1 and 2 and one transient occurrence of neurotoxicity grade 1 were observed. At the first efficacy assessment 6 weeks post infusion, 6 of 14 evaluable patients showed a partial response, and 5 patients had stable disease with shrinkage of target lesions. One patient showed no change from baseline and two patients were progressing. Responses were seen in testicular (n=4) and ovarian cancer (n=2) patients. At 12 weeks, 4 of the 6 patients with a partial response showed deepening and durability of responses with one patient reaching a complete response 18 weeks after infusion. All 4 testicular cancer patients in the higher dose level had disease control and 3 of these patients showed objective responses. In addition, 1 testicular cancer patient showed partial response after infusion of the lowest CAR-T dose level in combination with CARVac. Antitumor activity tended to be higher at the higher CAR-T dose and when combined with the vaccine, with 4 of 5 patients in the CARVac combination group showing a partial response. The ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) aims to evaluate the safety and preliminary efficacy of the CLDN6 CAR-T therapy alone and in combination with CARVac in heavily pretreated patients with CLDN6-positive relapsed or refractory advanced solid tumors and is conducted at multiple sites across Germany and the Netherlands. The next data update is expected later this year.

BioNTech SE Receives Pandemic Preparedness Contract by German Federal Ministry of Health

2022-04-08 13:24:00

BioNTech SE announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Germany. The framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany. Under the preparedness agreement, BioNTech will reserve and maintain manufacturing capabilities to produce at least 80 million mRNA-based vaccine doses per year. The contract has an initial term of five years.

Sachs Associates Ltd., 8th Annual Immuno-Oncology Innovation Forum, May 24, 2022 through May 25, 2022

2022-04-01 11:05:00

Sachs Associates Ltd., 8th Annual Immuno-Oncology Innovation Forum, May 24, 2022 through May 25, 2022.

BioNTech SE (NasdaqGS:BNTX) announces an Equity Buyback for $1,500 million worth of its shares.

2022-03-31 07:09:00

BioNTech SE (NasdaqGS:BNTX) announces a share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of its American depositary shares (ADSs). The company expects to use all or a portion of the ADSs to satisfy upcoming settlement obligations under the company’s share-based payment arrangements. The program is valid for 2 years.

BioNTech SE authorizes a Buyback Plan.

2022-03-31 00:00:00

The Board of Directors of BioNTech SE has authorized a buyback plan on March 31, 2022.

BioNTech Seeks Acquisitions

2022-03-30 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Jens Holstein, Chief Financial Officer said, "To supplement our technologies and digital capabilities, we strive to extend and augment our expertise with synergistic acquisitions and collaborations". Ryan Richardson, Chief Strategy Officer said, "we expect to remain active on the corporate development front. Already this year, we have announced a diverse set of new collaborations with Pfizer, Regeneron, Medigene and Crescendo. We will continue to expand our access to complementary technologies in the field of synthetic biology. And we will continue to invest in our manufacturing infrastructure and digital capabilities. This could include new partnerships, M&A and in-licensing deals in addition to organic investment".

Biontech Se Provides Revenue Guidance for the Financial Year 2022

2022-03-30 11:25:00

BioNTech SE provided revenue guidance for the financial year 2022. For the year, the company expects revenue of €13 billion - €17 billion.

BioNTech SE Proposes Special Cash Dividend

2022-03-30 10:00:00

BioNTech SE will proposed a special cash dividend of €2.00 per share at forthcoming 2022 Annual General Meeting.

BioNTech SE - Analyst/Investor Day

2022-03-30 10:00:00

Capital Markets Day for analysts and investors

BioNTech SE's Board intends to launch an Equity Buyback.

2022-03-30 00:00:00

On March 30, 2022, the company announced that its Board of Directors will consider a proposal for share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of its American Depositary Shares. The repurchased shares will be held as treasury shares. The program will be valid for a period of 2 years.

Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older

2022-03-29 14:30:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses. The expanded EUA is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers 18 years of age and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose.1 No new safety concerns were noted among study participants.1 The companies also shared with the FDA data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster,2-6 and evidence from Israel that an additional booster dose can improve protection against severe disease and death. The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized now for those age 50 years and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: The vaccine will be given as an injection into the muscle. Primary Series: In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise. Booster Dose: A first booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older. A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose. A second booster dose may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any of authorized COVID-19 vaccine. A second booster dose of the vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized COVID-19 vaccine to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older It is also authorized under EUA to provide: a 2-dose primary series to individuals 12 through 15 years of age. a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series. a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

BioNTech SE Presents at 14th Kempen Life Sciences Conference, Apr-20-2022

2022-03-29 06:52:00

BioNTech SE Presents at 14th Kempen Life Sciences Conference, Apr-20-2022 . Venue: Amsterdam, Netherlands.

JPMorgan Chase & Co., JP Morgan 11th Annual Napa Valley Biotech Forum, Apr 05, 2022

2022-03-27 23:13:00

JPMorgan Chase & Co., JP Morgan 11th Annual Napa Valley Biotech Forum, Apr 05, 2022. Venue: San Francisco, United States.

BioNTech SE Presents at JP Morgan 11th Annual Napa Valley Biotech Forum, Apr-06-2022 10:00 AM

2022-03-27 23:13:00

BioNTech SE Presents at JP Morgan 11th Annual Napa Valley Biotech Forum, Apr-06-2022 10:00 AM. Venue: San Francisco, United States.

BioNTech SE Presents at Jefferies Biotech on the Bay Summit, Apr-26-2022

2022-03-27 23:13:00

BioNTech SE Presents at Jefferies Biotech on the Bay Summit, Apr-26-2022 . Venue: St. Regis, Bal Harbour, Florida, United States.

Jefferies LLC, Jefferies Biotech on the Bay Summit, Apr 26, 2022 through Apr 27, 2022

2022-03-25 10:39:00

Jefferies LLC, Jefferies Biotech on the Bay Summit, Apr 26, 2022 through Apr 27, 2022. Venue: St. Regis, Bal Harbour, Florida, United States.

BioNTech SE Presents at Bank of America 2022 Healthcare Conference, May-12-2022 08:00 AM

2022-03-22 05:03:00

BioNTech SE Presents at Bank of America 2022 Healthcare Conference, May-12-2022 08:00 AM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

BioNTech SE Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-03-2022 09:00 AM

2022-03-18 04:06:00

BioNTech SE Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-03-2022 09:00 AM. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States. Speakers: Ugur Sahin, Co-Founder, CEO & Member of Management Board.

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022

2022-03-17 15:04:00

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States.

BioNTech SE Presents at The 13th Global Drug Delivery & Formulation Summit, Jun-27-2022

2022-03-03 04:09:00

BioNTech SE Presents at The 13th Global Drug Delivery & Formulation Summit, Jun-27-2022 . Venue: Berlin, Germany. Speakers: Heinrich Haas, Vice President Formulation & Drug Delivery.

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States.

Mark Allen Holdings Limited, the 13th Global Drug Delivery & Formulation Summit, Jun 27, 2022 through Jun 29, 2022

2022-02-16 09:24:00

Mark Allen Holdings Limited, The 13th Global Drug Delivery & Formulation Summit, Jun 27, 2022 through Jun 29, 2022. Venue: Berlin, Germany. Formulation design for poorly soluble compoundsThe potential of nanotechnology for better deliverabilityThe latest controlled released technologiesImproving patient compliance by harnessing data and thelatest smart device technologyOptimising formulations for continuous manufacturingOvercoming the blood brain barrier and challenges in oraldelivery of biologicsReformulation and biosimilarsDay 1 7:40 AM - 8:40 AMRegistration & Refreshments8:40 AM - 8:50 AMChair's Opening Remarks8:50 AM - 9:35 AM - Panel Discussion9:40 AM - 10:10 AM - Case Studies10:15 AM - 10:45 AM - Solution Spotlights10:45 AM - 11:35 AM1-2-1 Pre-Scheduled Meetings & Networking Break12:10 PM - 12:55 PM - Solution Spotlights12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:25 PM - Panel Discussion2:30 PM - 3:00 PM - Solution Spotlights3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - Case Studies5:15 PM - 6:00 PM - Panel DiscussionDevice DevelopmentImproving Patient Experience Through Digital and Combination Products6:00 PM - 6:05 PMChair’s Closing Remarks6:05 PM - 7:05 PMEvening Networking ReceptionDay 28:00 AM - 8:30 AMRegistration & Refreshments8:30 AM - 8:45 AMChair's Opening Remarks8:45 AM - 9:15 AM - Keynote9:20 AM - 9:50 AM - Case Studies9:55 AM - 10:25 AM - Solution Spotlights10:25 AM - 11:15 AM1-2-1 Pre-Scheduled Meetings & Networking Break11:15 AM - 11:45 AM - Case Studies11:50 AM - 12:20 PM - Solution SpotlightsTechnology & Innovation12:25 PM - 12:55 PM - Case Studies12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:25 PM - Case Studies2:30 PM - 3:00 PM - Solution Spotlights3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - KeynoteTechnology & Innovation5:10 PM - 5:15 PMChair’s Closing Remarks5:15 PM - 6:15 PMEvening Networking ReceptionDay 38:30 AM - 9:00 AMRegistration & Refreshments9:00 AM - 9:05 AMChair’s Opening Remarks9:20 AM - 9:50 AM - KeynoteTechnology & InnovationReducing the Cost of Developing Medical Devices9:55 AM - 10:25 AM - Case Studies10:30 AM - 11:00 AM - Solution Spotlights11:00 AM - 11:50 AM1-2-1 Pre-Scheduled Meetings & Networking Break11:50 AM - 12:20 PM - Case Studies12:25 PM - 12:55 PM - Solution Spotlights12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:40 PM - Case Studies2:45 PM - 3:15 PM - Case Studies3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - KeynoteTechnology & Innovation5:10 PM - 5:25 PMPoster Presentation Award5:25 PM - 5:30 PMChair’s Closing Remarks.

Hanson Wade Limited, 5th European Neoantigen Summit 2022, Apr 26, 2022 through Apr 28, 2022

2022-02-16 04:05:00

Hanson Wade Limited, 5th European Neoantigen Summit 2022, Apr 26, 2022 through Apr 28, 2022. Venue: Amsterdam, Netherlands.

BioNTech SE Presents at Eighth Annual Berenberg Conference USA 2022, May-23-2022 10:15 AM

2022-02-15 17:59:00

BioNTech SE Presents at Eighth Annual Berenberg Conference USA 2022, May-23-2022 10:15 AM. Venue: Tarrytown House Estate, 49 East Sunnyside Lane, Tarrytown, New York, New York, United States. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Pfizer and BioNTech Provides Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age

2022-02-11 18:30:00

Pfizer Inc. and BioNTech SE announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA. The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge. In December 2021, Pfizer and BioNTechannounced that the ongoing clinical study would evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April. The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen. The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.

BioNTech SE to Report Q4, 2021 Results on Mar 30, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q4, 2021 results at 8:00 AM, US Eastern Standard Time on Mar 30, 2022

BioNTech SE to Report Q1, 2022 Results on May 09, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q1, 2022 results at 8:00 AM, US Eastern Standard Time on May 09, 2022

BioNTech SE to Report Q2, 2022 Results on Aug 08, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q2, 2022 results at 8:00 AM, US Eastern Standard Time on Aug 08, 2022

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022

2022-02-08 07:31:00

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Pfizer Inc. and BioNTech SE Initiate Rolling Submission for Emergency Use Authorization of Their Covid-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

2022-02-01 21:27:00

Pfizer Inc. and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA. Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S.,i with children under 4 accounting for more than 1.6 million of those cases.ii Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.2 If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern. The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity and available efficacy of two doses of the Pfizer-BioNTech COVID-19 Vaccine. The companies also plan to share these data with the European Medicines Agency and other regulatory agencies around the world. The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application. The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 2022.

BioNTech SE, Annual General Meeting, Jun 01, 2022

2022-01-24 00:05:00

BioNTech SE, Annual General Meeting, Jun 01, 2022, at 14:00 Central European Standard Time. Agenda: To consider the presentation of the adopted annual financial statements, the approved consolidated financial statements, and the combined management report for the company and the group as well as the report of the supervisory board for the company, each for the 2021 financial year or as of 31 December 2021, respectively; to consider and pass the resolution on the appropriation of the balance sheet profit; and to discuss other matters.

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

2022-01-07 14:32:00

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

2022-01-07 14:32:00

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

2022-01-07 14:32:00

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

U.S. Food and Drug Administration Expands the Emergency Use Authorization of Booster Dose of the Pfizer and Biontech

2022-01-03 21:39:00

On January 3, 2022, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age and older.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

2022-01-03 14:45:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series. A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.

Joh. Berenberg, Gossler & Co. KG, Eighth Annual Berenberg Conference USA 2022, May 23, 2022 through May 25, 2022

2021-12-21 05:07:00

Joh. Berenberg, Gossler & Co. KG, Eighth Annual Berenberg Conference USA 2022, May 23, 2022 through May 25, 2022. Venue: Tarrytown House Estate, 49 East Sunnyside Lane, Tarrytown, New York, New York, United States. The conference will bring together companies to present their corporate strategy, current trends and challenges. Running in parallel with the main presentations, companies will be hosting small group and one-on-one meetings.

Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply

2021-12-20 15:05:00

Pfizer Inc. and BioNTech SE announced an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY®, the companies’ COVID-19 vaccine. Contractual details are currently being finalized. These 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to the EC member states by the companies in 2022 will now total more than 650 million doses. This order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved. Pfizer and BioNTechagreed in May to supply 900 million doses to the European Commission (EC) in 2022 and 2023, with option to request up to an additional 900 million doses. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer Inc. and BioNTech SE Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

2021-12-09 17:15:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 16 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series. A booster dose of the Pfizer-BioNTech COVID-19 vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 18 years of age and older, as well as for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Pfizer and BioNTech plan to submit a supplemental Biologics License Application (sBLA) for approval of a booster dose of their COVID-19 vaccine in individuals 16 years of age and older. The sBLA will include efficacy and safety data from a Phase 3 trial showing that a 30-µg booster dose administered to individuals 16 years and older who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. These are the first efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile. Pfizer and BioNTech continue to supply the vaccine, including booster doses, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world. The Phase 3 trial evaluated the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine in more than 10,000 individuals 16 years of age and older in the United States, Brazil, and South Africa. All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech COVID-19 Vaccine, and then were randomized 1:1 to receive either a 30-µg booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years of age, and 23.3% of participants 65 years of age and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

BioNTech SE - Special Call

2021-12-08 12:15:00

To Provide an Update on Omicron Variant

Pfizer and BioNTech Provide Update on Omicron Variant

2021-12-08 11:54:00

Pfizer Inc. and BioNTech SE announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccines one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses. Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant. However, as the vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron, the companies believe that vaccinated individuals may still be protected against severe forms of the disease and are closely monitoring real world effectiveness against Omicron, globally. A more robust protection may be achieved by a third dose as data from additional studies of the companies indicate that a booster with the current COVID-19 vaccine from Pfizer and BioNTech increases the antibody titers by 25-fold. According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants. A third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes which are considered to correlate with the protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant. While these results are preliminary, the companies will continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron and inform the most effective path forward. On November 25, the companies started to develop an Omicron-specific COVID-19 vaccine. The development will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. First batches of the Omicron-based vaccine can be produced and are planned to be ready for deliveries within 100 days, pending regulatory approval. Pfizer and BioNTech have tested other variant-specific vaccines as well, which have produced very strong neutralization titers and a tolerable safety profile. Based on this experience the companies have high confidence that if needed they can deliver an Omicron-based vaccine in March 2022. The companies have also previously initiated clinical trials with variant-specific vaccines (Alpha, Beta, Delta & Alpha/Delta Mix) and data from these studies will be submitted to regulatory agencies around the world to help accelerate the process of adapting the vaccine and gaining regulatory authorization or approval of an Omicron-specific vaccine, if needed. The companies have previously announced that they expect to produce four billion doses of BNT162b2 in 2022, and this capacity is not expected to change if an adapted vaccine is required.

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union

2021-11-25 12:30:00

Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states. If approved, COMIRNATY will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age. The positive opinion adopted by the CHMP is based on scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, as compared to the 30-µg doses used in individuals 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalant strain. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine. Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for pediatric doses, under their existing supply agreement with the EC. The companies do not expect the introduction of pediatric doses in the United States and the European Union, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world. Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world. The companies expect initial pivotal data from their ongoing clinical trial in 2 to under 5 years of age this quarter, and in 6 month to under 2 years of age in the first quarter 2022, with full data readouts to follow. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing. COMIRNATY® (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorization (CMA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 12 years of age. The vaccine is administered as a 2-dose series, 3 weeks apart. In addition, the CMA has been expanded to include a booster dose (third dose) at least 6 months after the second dose in individuals 18 years of age and older. For immunocompromised individuals, the third dose may be given at least 28 days after the second dose. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available. Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY® may be lower in immunosuppressed individuals. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine. In clinical studies, adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. The overall safety profile of COMIRNATY® in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in clinical trial participants 12 to 15 years of age were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%). There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. It is unknown whether COMIRNATY® is excreted in human milk. Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied. For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

Pfizer Inc. and BioNTech SE Announces Topline Results from Longer-Term Analysis of the Safety and Efficacy of COVID-19 Vaccine in Individuals 12 Through 15 Years of Age

2021-11-22 11:45:00

Pfizer Inc. and BioNTech SE announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age. The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least 6 months of safety follow-up after the second dose. These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application (sBLA) to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older. The vaccine is currently available for individuals 12 to 15 years of age under Emergency Use Authorization (EUA), granted by the FDA in May 2021. The companies also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted. About the Analysis in Adolescents 12-15 Years of Age: The updated analysis of the Phase 3 clinical trial in individuals ages 12 to 15 years was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Data through up to six months after the primary vaccination series are required for licensure. These data were collected from November 2020 to September 2021. Results from this analysis of 2,228 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]). Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status. Pfizer and BioNTech plan to submit these data for scientific peer review for potential publication. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer and BioNTech Receive Health Canada Authorization of COVID-19 Vaccine COMIRNATY in Children Ages 5 Through <12 Years

2021-11-19 14:30:00

Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized COMIRNATY, the companies' COVID-19 vaccine for children 5 to under 12 years of age . For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given three weeks apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in Canada for individuals 5 to under 12 years of age. Health Canada based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4600 children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Shipping of 10-µg pediatric doses to Canadian immunization sites in partnership with the Public Health Agency of Canada will begin imminently (ages referred to as 5y to <12y on the vial and 5 years to <12 years on the carton).

Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older

2021-11-19 13:25:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series. In October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified. A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that news will impact the existing supply agreements in place with governments and international health organizations around the world. About the Phase 3 COVID-19 Booster Trial; The Phase 3 trial evaluated the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older in the U.S., Brazil, and South Africa. All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech COVID-19 Vaccine, and then were randomized 1:1 to receive either a 30-µg booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years, and 23.3% of participants 65 years and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma

2021-11-19 11:30:00

BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTechs fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer. The vaccine candidate is currently being investigated in a Phase 2 trial (EudraCT No.: 2020-002195-12 [2]; NCT04526899 [3]) in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma. The Fast Track Designation underlines the potential of FixVac platform to address current treatment challenges of pre-treated and immune checkpoint blocker experienced melanoma with limited standard of care therapy options left. Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need. The FDAs decision is based on available preclinical and clinical data showing the potential of BNT111 to overcome current limitations in the treatment of inoperable therapy-resistant advanced-stage melanoma. With the Fast Track Designation, the development of BNT111 can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate BNT111s development. The ongoing randomized Phase 2 trial (BNT111-01 [4]) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma investigates BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi. The BNT111-01 trial which is conducted in collaboration with Regeneron is enrolling a total of 180 patients into three treatment arms in the United States, the United Kingdom, Australia, Spain, Germany, Italy and Poland. This trial seeks to support initial data reported from the ongoing Phase 1 Lipo-MERIT monotherapy dose escalation trial (EudraCT No. 2013-001646-33 [5]; NCT02410733 [6]; DOI: 10.1038/s41586-020-2537-9 [7]) that demonstrated a favorable safety profile and anti-tumor responses of BNT111 alone and in combination with immune checkpoint inhibitor therapy in patients with advanced melanoma.

Kempen & Co, 14th Kempen Life Sciences Conference, Apr 20, 2022 through Apr 21, 2022

2021-11-13 00:00:00

Kempen & Co, 14th Kempen Life Sciences Conference, Apr 20, 2022 through Apr 21, 2022. Venue: Amsterdam, Netherlands.

Elicera Therapeutics enters agreement with BioNTech for contract manufacturing of viral vectors for CAR T-cell therapy

2021-11-09 13:30:00

Elicera Therapeutics AB (publ) announced that it has entered into an agreement with BioNTech for contract manufacturing regarding viral vectors for the company's CAR T-cell therapy, ELC-401. BioNTech IMFS is a contract development and manufacturing organization in Germany that specializes in the industrialization of cell and gene therapies such as virus vectors and cell products. Elicera Therapeutics has entered into an agreement with BioNTech that regulates contract manufacturing of the retroviral vector that will be used to construct CAR T-cells for a phase I/II clinical study with ELC-401 in the treatment of glioblastoma, the most aggressive form of brain cancer.

BioNTech SE (NasdaqGS:BNTX) acquired PhagoMed Biopharma GmbH for approximately €130 million.

2021-11-09 00:00:00

BioNTech SE (NasdaqGS:BNTX) acquired PhagoMed Biopharma GmbH for approximately €130 million on October 1, 2021. Upon completion name will be changed to BioNTech R&D (Austria) GmbH. The total consideration comprised an upfront consideration of €50 million (less acquired debt) of which €23.2 million are considered remuneration and will be recognized as personnel expense over a three-year period in which services are to be provided with the possibility of the selling shareholders earning up to an additional €100.0 million through the achievement of certain clinical development milestones. BioNTech SE (NasdaqGS:BNTX) completed the acquisition of PhagoMed Biopharma GmbH on October 1, 2021.

BioNTech SE Presents at 9th International mRNA Health Conference, Nov-09-2021 through Nov-10-2021

2021-11-04 14:46:00

BioNTech SE Presents at 9th International mRNA Health Conference, Nov-09-2021 through Nov-10-2021. Presentation Date & Speakers: Nov-09-2021, Katalin Kariko, Senior VP & Head of RNA Protein Replacement, Mustafa Diken, Vice President of Vaccines & Immunology, Özlem Türeci, Chief Medical Officer, Ugur Sahin, Co-Founder, CEO & Member of Management Board. Nov-10-2021, Christina Krienke, Head of the Team Autoimmunity, Jan D. Beck, Scientist Cancer Vaccines, Katalin Kariko, Senior VP & Head of RNA Protein Replacement, Mathias Vormehr, Director Cancer Vaccines.

BioNTech SE Presents at 3rd Annual Wolfe Research Virtual Healthcare Conference 2021, Nov-17-2021

2021-11-02 01:14:00

BioNTech SE Presents at 3rd Annual Wolfe Research Virtual Healthcare Conference 2021, Nov-17-2021 .

BioNTech SE Presents at Cowen’s 5th Annual IO Next Virtual Summit, Nov-17-2021 09:15 AM

2021-11-01 23:03:00

BioNTech SE Presents at Cowen’s 5th Annual IO Next Virtual Summit, Nov-17-2021 09:15 AM.

BioNTech SE to Present New Clinical Data from First-In-Class Car-T Program Bnt211 in Late-Breaking Session at 36th SITC Annual Meeting

2021-11-01 12:00:00

BioNTech SE announced that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation. The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held both in person and virtually from November 10 - 14, 2021. BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 and the first CAR-T product candidate in the company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine in a first-in-human Phase 1/2 clinical trial to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

U.S. Food and Drug Administration Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 Through 11 Years of Age

2021-10-29 19:28:00

U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA's thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks. FDA evaluation of available effectiveness data: the effectiveness data to support the EUA in children down to 5 years of age is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children 5 through 11 years of age. The study is being conducted in the U.S., Finland, Poland and Spain. Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 Vaccine containing 10 micrograms of messenger RNA per dose. The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune responses of the younger age participants were comparable to the older participants. The FDA also conducted a preliminary analysis of cases of COVID-19 occurring seven days after the second dose. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, 3 cases of COVID-19 occurred among 1,305 vaccine recipients and 16 cases of COVID-19 occurred among 663 placebo recipients; the vaccine was 90.7% effective in preventing COVID-19. FDA evaluation of available safety data: the available safety data to support the EUA include more than 4,600 participants (3,100 vaccine, 1,538 placebo) ages 5 through 11 years enrolled in the ongoing study. In this trial, a total of 1,444 vaccine recipients were followed for safety for at least 2 months after the second dose. Commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days. The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk high in males 12 through 17 years of age. Therefore, the FDA conducted its own benefit-risk assessment using modelling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA's model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age. Ongoing safety monitoring: Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children 5 through 11 years of age. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety problems. It is mandatory for Pfizer Inc. and vaccination providers to report to any serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death in vaccinated individuals. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Pfizer Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports to the FDA. The FDA also authorized a manufacturing change for the vaccine to include a formulation that uses a different buffer; buffers help maintain a vaccine's pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for long periods of time, permitting great flexibility for vaccination providers. The new formulation of the vaccine developed by Pfizer Inc. contains Tris buffer, a commonly used buffer in a variety of other FDA-approved vaccines and other biologics, including products for use in children. The FDA evaluated manufacturing data to support the use of Pfizer-BioNTech COVID-19 Vaccine containing Tris buffer and concluded it does not present safety or effectiveness concerns.

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, United States.

BioNTech SE to Report Q3, 2021 Results on Nov 09, 2021

2021-10-27 11:00:00

BioNTech SE announced that they will report Q3, 2021 results on Nov 09, 2021

FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years

2021-10-26 22:19:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend the FDA grant Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine in children 5 to <12 years of age. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy. The committee reviewed the totality of scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included 4,500 children 5 to <12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine. The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine available for use in children 5 to <12 years of age in the U.S. The companies expect to then begin shipping pediatric vaccine doses immediately, as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines. Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned or ongoing.

BioNTech SE Plans to Initiate the Construction of an MRNA Vaccine Manufacturing Facility in Africa in Mid-2022

2021-10-26 12:00:00

BioNTech SE announced that the Company plans to initiate the construction of the first manufacturing site for mRNA-based vaccines in the African Union in mid-2022. This is the next step in BioNTech’s efforts to implement sustainable end-to-end vaccine supply solutions on the African continent. The decision is the result of a meeting between Rwanda’s Minister of Health, Dr. Daniel M. Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, Ugur Sahin, M.D.,CEO and Co-Founder of BioNTech and Sierk Poetting, COO of BioNTech as well as Dr. Sabin Nsanzimana, Director-General of Rwanda Biomedical Centre and Dr. Amadou Alpha Sall, Directeur-General of Institut Pasteur de Dakar in Kigali, Rwanda. The meeting occurred upon the invitation of the kENUP Foundation and took place as a side-event of the Second Ministerial Meeting of the African Union and the European Union and resulted in a Memorandum of Understanding (MoU). This comes after the parties signed a Joint Communiqué at a previous meeting in Berlin on August 27, 2021. The parties agree to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately. BioNTech has finalized the construction plans and ordered the assets, which will be delivered by mid-2022. The new manufacturing facility could become the first node in a decentralized and robust African end-to-end manufacturing network enabling an annual manufacturing capacity of several hundreds of million mRNA vaccine doses. BioNTech plans to develop and implement a scalable construction network based on the expertise and learnings from the ramp-up of the Company’s production facility in Marburg. To enable an expedient set-up of production capacities according to GMP standards, BioNTech will start with the construction and validation of a first production line enabling the manufacturing of drug product for about 50 million of e.g. COVID-19 vaccine doses per year, once fully operational. The capacity will be increased sequentially by adding further manufacturing lines and sites to the manufacturing network on the continent, supporting the production of several hundreds of millions of mRNA vaccine doses. BioNTech will initially staff, own and operate the facility to support the safe and rapid initiation of the production of mRNA-based vaccine doses. BioNTech plans to transfer manufacturing capacities and the know-how to local partners. Therefore, BioNTech, the Rwanda Development Board and Institut Pasteur de Dakar in Senegal agreed to swiftly build-up the required human resources capacity and systems so that the partners can take over ownership and operational duties. In parallel, the Republic of Rwanda and the Institut Pasteur de Dakar have committed themselves to scale-up fill and finish capacities to complete the local end-to-end manufacturing process. In addition, BioNTech is in discussions about an expansion of the current partnership with Cape Town-based vaccine manufacturer Biovac, which is part of the Pfizer-BioNTech COVID-19 vaccine manufacturing network.

Cowen and Company, LLC, Cowen’s 5th Annual IO Next Virtual Summit, Nov 15, 2021

2021-10-25 20:58:00

Cowen and Company, LLC, Cowen’s 5th Annual IO Next Virtual Summit, Nov 15, 2021.

Pfizer Inc and BioNTech SE Announces Topline Results from Phase 3 Randomized

2021-10-21 11:10:00

2021 Pfizer Inc. and BioNTech SE announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30- g booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial. These important data add to the body of evidence suggesting that a booster dose of vaccine can help protect a broad population of people from this virus and its variants," said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. Based on these findings they believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy. All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech vaccine, and then were randomized 1 1 to receive either a 30- g booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. During the study period, there were 5 cases of COVID-19 in the boosted group, and 109 cases in the non-boosted group. The observed relative vaccine efficacy of 95.6% (95% CI 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years, and 23.3% of participants 65 years and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified. Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication. The companies also plan to share these data with the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible.

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine

2021-10-21 10:45:00

Pfizer Inc. and BioNTech SE announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial. All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech vaccine, and then were randomized 1:1 to receive either a 30-µg booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. During the study period, there were 5 cases of COVID-19 in the boosted group, and 109 cases in the non-boosted group. The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years, and 23.3% of participants 65 years and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified. Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication. The companies also plan to share these data with the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer Inc and BioNTech SE Announces European Medicines Agency‘s Committee for Human Medicinal Products Issued A Positive Opinion for a New Formulation of COMIRNATY

2021-10-19 10:08:00

Pfizer Inc. and BioNTech SE announced that the European Medicines Agency‘s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive opinion for a new formulation of COMIRNATY® (COVID-19 vaccine, mRNA). The new formulation does not require the dilution of the concentrate and will be available in a 10-vial (60 dose) pack size, therefore, helps ensure simplified handling of the vaccine. All other aspects, including the antigen and the lipids of the vaccine, remain unchanged. The thawed vial contains six doses, which can be administered directly. In addition, the new formulation allows for longer storage. Vials can be stored for 10 weeks at fridge temperatures from 2°C to 8°C, while the current formulation can be stored at fridge temperature (2-8°C) for 31 days. After first puncture, the vials with the new formulation can be stored and transported at 2 °C to 30 °C and used within 12 hours, which is longer than the current formulation, where the product stability is 6 hours at 2 ºC to 30 ºC after first puncture. The new formulation for the currently approved population (individuals 12 and older) will be available in a phased rollout starting in early 2022. If authorized, the vaccine for the younger population from 5 to <12 years of age will be based on the new formulation, which will be adapted to allow a lower dose level of 10 µg after dilution. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing. Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reactiofollowing the administration of the vaccine. Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY® may be lower in immunosuppressed individuals. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine. In clinical studies, adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. The overall safety profile of COMIRNATY® in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in clinical trial participants 12 to 15 years of age were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%). There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. It is unknown whether COMIRNATY® is excreted in human milk.Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied. For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

Pfizer Inc and BioNTech SE Submits Data to Ema for the Vaccination of Children 5 to Less Than 12 Years of Age

2021-10-18 12:53:00

Pfizer Inc. and BioNTech SE announced that they submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 mRNA vaccine) to the European Medicines Agency (EMA) for a variation of the Conditional Marketing Authorization (CMA) in the European Union (EU). The variation request includes data from a Phase 2/3 study, which is enrolling children 6 months to <12 years of age. The 2,268 participants who were 5 to <12 years of age received a 10-µg dose level in a two-dose regimen administered 21 days apart. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. The antibody responses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-µg doses. The COVID-19 vaccine was well tolerated in the younger age group. The 10-µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age. The same data have been submitted to the U.S. Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing.

BioNTech SE Presents at The Milken Institute Global Conference, Oct-19-2021 11:30 AM

2021-10-16 01:33:00

BioNTech SE Presents at The Milken Institute Global Conference, Oct-19-2021 11:30 AM. Venue: The Beverly Hilton Hotel, Los Angeles, California, United States. Speakers: Ozlem Tureci, Chief Medical Officer & Member of Management Board, Ugur Sahin, Co-Founder, CEO & Member of Management Board.

Interplan AG, 9th International mRNA Health Conference, Nov 09, 2021 through Nov 10, 2021

2021-10-13 17:05:00

Interplan AG, 9th International mRNA Health Conference, Nov 09, 2021 through Nov 10, 2021.

Interplan AG, 9th International mRNA Health Conference, Nov 09, 2021 through Nov 10, 2021

2021-10-13 17:05:00

Interplan AG, 9th International mRNA Health Conference, Nov 09, 2021 through Nov 10, 2021.

Informa plc, TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov 15, 2021 through Nov 17, 2021

2021-10-12 20:23:00

Informa plc, TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov 15, 2021 through Nov 17, 2021.

BioNTech SE Presents at TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov-15-2021 through Nov-17-2021

2021-10-12 20:23:00

BioNTech SE Presents at TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov-15-2021 through Nov-17-2021. Presentation Date & Speakers: Nov-15-2021, Ulrich Blaschke, Vice President, Technical Development. Nov-16-2021, Julia Schlereth, Director RNA Analytics.

BioNTech SE Presents at China Investor Conference 2021- Shanghai, Nov-01-2021

2021-10-08 01:04:00

BioNTech SE Presents at China Investor Conference 2021- Shanghai, Nov-01-2021 . Venue: Shanghai City, China.

BioNTech SE Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-16-2021

2021-10-08 01:04:00

BioNTech SE Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-16-2021 . Venue: London, United Kingdom.

Pfizer Inc. and BioNTech SE Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union

2021-10-04 16:10:00

Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states. The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY®. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY. Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses in the United States and the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing. COMIRNATY® (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 12 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

BioNTech SE Presents at Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov-12-2021 12:25 PM

2021-10-01 12:13:00

BioNTech SE Presents at Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov-12-2021 12:25 PM. Venue: Walter E. Washington Convention Center, District Of Columbia, Washington, United States.

BioNTech SE to Present New Clinical and Preclinical Data Across Multiple Immuno-Oncology Programs at 36th SITC Annual Meeting

2021-10-01 12:12:00

BioNTech SE announced that new clinical and preclinical data will be presented in six posters and one presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021. The presentations will include new data from multiple programs across various drug classes along with first-in-human data for three programs. This is the data collection the company will present at a scientific meeting, showcasing BioNTech’s diversified oncology pipeline.

BioNTech Expands Clinical Oncology Portfolio with First Patient Dosed in Phase 2 Trial of mRNA-based Individualized Immunotherapy BNT122 in Colorectal Cancer Patients

2021-10-01 06:00:00

BioNTech SE announced that the first colorectal cancer patient has been treated with its individualized mRNA cancer vaccine BNT122 (autogene cevumeran, RO7198457) in a Phase 2 clinical trial. The trial has been initiated in the United States, Germany, Spain and Belgium. It is planned to enroll about 200 patients to evaluate the efficacy of RO7198457 (BNT122) compared to watchful waiting after surgery and chemotherapy, the current standard of care for these high-risk patients. As the second deadliest cancer worldwide, the medical need for novel therapies to treat colorectal cancer remains high. The open-label Phase 2 trial (NCT04486378) is investigating autogene cevumeran in stage II/III colorectal cancer patients after surgical resection of their tumor and completion of adjuvant chemotherapy. The current standard of care in this indication is watchful waiting to see if tumors recur after removal of the primary tumor and adjuvant chemotherapy. A proportion of these patients are expected to have a recurrence of their tumor within 2-3 years after their surgery: in the clinical trial, patients at high risk for recurrence will be identified early on with a highly sensitive blood test detecting circulating tumor DNA (ctDNA). The Phase 2 trial will investigate the efficacy of autogene cevumeran as a single agent compared to standard of care watchful waiting in this high-risk patient population. The primary endpoint for the study is disease-free survival (DFS). Secondary objectives include relapse-free survival (RFS), overall survival (OS) and safety. The first patient in the trial has been treated at a clinical site in Europe. The Phase 2 trial is based on previous results from the Phase 1a/1b basket trial evaluating autogene cevumeran as a single agent and in combination with atezolizumab, an anti-PD-L1 antibody, in patients with solid tumors (NCT03289962). The data show the induction of neoantigen-specific T cell responses, a manageable safety profile and objective responses as indication of clinical activity. In parallel to the ongoing Phase 2 study, BioNTech has initiated an epidemiological study (NCT04813627) to investigate ctDNA status in patients with stage II/III colorectal cancer following resection or prior to adjuvant chemotherapy to identify patients who might be potential candidates for the Phase 2 trial. In Germany, trial screening is supported by the molecular registry Colopredict Plus 2.0 (AIO-KRK-0413/ass) of the Association for Internal Oncology (AIO), a working group of the German Cancer Society, and the Ruhr University Bochum.

BioNTech SE Presents at Longwood Healthcare Leaders Conference, Oct-05-2021 09:20 AM

2021-09-28 18:44:00

BioNTech SE Presents at Longwood Healthcare Leaders Conference, Oct-05-2021 09:20 AM. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021

2021-09-28 13:09:00

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021.

Pfizer and BioNTech Submits Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age

2021-09-28 10:45:00

Pfizer Inc. and BioNTech SE announced they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to About the Phase 1/2/3 Trial in Children. The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to COMIRNATY®U.S. Indication & Authorized Use The vaccine will be given as an injection into the muscle. Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise. Booster Dose: A single booster dose of the vaccine may be administered to individuals: 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID `19. The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under EUA to be administered to provide: a two-dose primary series in individuals 12 through 15 years; a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and a single booster dose in individuals: 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID `19. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: a two-dose primary series in individuals 12 years of age and older; a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and a single booster dose in individuals: 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19 and 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID `19.

Pfizer Inc and BioNTech SE Receives First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster

2021-09-23 01:44:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series. The FDA based this EUA on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine. As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans. Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world. Pfizer and BioNTech have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion doses each year. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer and BioNTech Expand Collaboration with U.S. to Provide 500 Million Additional COVID-19 Vaccine Doses at Not-for-Profit Price for Donation to Poorest Countries

2021-09-22 10:02:00

Pfizer Inc. and BioNTech SE announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies’ COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them. This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion. Consistent with the initial agreement, the U.S. government will allocate doses of the Pfizer-BioNTech COVID-19 Vaccine to 92 low- and lower-middle-income countries as defined by Gavi’s COVAX Advanced Market Commitment (AMC) and the 55 member states of the African Union. Deliveries of the initial 500 million doses began in August 2021, and the total one billion doses under the expanded agreement are expected to be delivered by the end of September 2022. The current plan is to produce these doses in Pfizer’s U.S. facilities located in Kalamazoo, MI, Andover, MA, Chesterfield, MO, and McPherson, KS. Overall, Pfizer and BioNTech have shipped more than 1.5 billion COVID-19 vaccine doses worldwide. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with governments and health partners worldwide, and have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion each year. In addition to the supply agreement with the U.S. government, this includes direct supply agreements with individual country governments and a direct supply agreement with COVAX for 40 million doses in 2021. The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to: prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

Pfizer Inc. and BioNTech SE Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years

2021-09-20 10:45:00

Pfizer Inc. and BioNTech SE announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group. The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age. Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication. The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to 11 years received two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to: prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

Pfizer Canada ULC and BioNTech SE Announce Health Canada Grants Full Approval for COMIRNATY® to Prevent COVID-19 in Individuals 12 Years of Age and Older

2021-09-16 15:46:00

Pfizer Canada ULC and BioNTech SE announced that Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older. The vaccine was initially authorized for use in Canada under an interim order authorization on December 9, 2020 and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine. The authorization permitted essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the phase 3 clinical trial. Although the vaccine's brand name will be COMIRNATY following this approval, Canada will continue to receive vials of the vaccine labeled as Pfizer-BioNTech COVID-19 Vaccine. The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date. For this full approval (Notice of Compliance; NOC) of the new drug submission (NDS), Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the phase 3 trial, where the vaccine's efficacy and safety profile were observed up to six months after the second dose. The NDS package also included the manufacturing and facilities data required for licensure.

BioNTech SE Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 08:40 AM

2021-09-15 20:23:00

BioNTech SE Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 08:40 AM. Venue: New York, United States.

BioNTech SE Presents at BioProcess International Conference & Exhibition, Sep-20-2021

2021-09-08 22:27:00

BioNTech SE Presents at BioProcess International Conference & Exhibition, Sep-20-2021 . Speakers: Katalin Kariko, Senior VP & Head of RNA Protein Replacement.

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021

2021-09-08 21:27:00

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021.

Pfizer and BioNTech Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY

2021-09-07 10:48:00

Pfizer Inc. and BioNTech SE announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The same data had been submitted to the FDA and will be filed with other regulatory authorities in the upcoming weeks. The submitted variation includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of COMIRNATY, between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post-booster. The booster (third) dose of COMIRNATY elicited significantly higher SARS-CoV-2 neutralizing antibody titers against the wild-type strain compared to the levels observed after the two-dose primary series. Phase 1 data also were submitted, showing a similar pattern of booster responses against the wild-type, Beta and Delta variants. The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY. Pfizer and BioNTech intend to submit these data to a peer-reviewed journal. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Wolfe Research, LLC, 3rd Annual Wolfe Research Virtual Healthcare Conference 2021, Nov 17, 2021 through Nov 18, 2021

2021-09-03 06:27:00

Wolfe Research, LLC, 3rd Annual Wolfe Research Virtual Healthcare Conference 2021, Nov 17, 2021 through Nov 18, 2021.

Reuters Events, Reuters NEXTreturns, Dec 01, 2021 through Dec 03, 2021

2021-08-30 16:41:00

Reuters Events, Reuters NEXTreturns, Dec 01, 2021 through Dec 03, 2021.

BioNTech SE Presents at Reuters NEXTreturns, Dec-01-2021

2021-08-30 16:41:00

BioNTech SE Presents at Reuters NEXTreturns, Dec-01-2021 . Speakers: Özlem Türeci, Chief Medical Officer.

BioNTech Evaluates mRNA Vaccine Manufacturing Solutions in Rwanda and Senegal to Improve Long-Term Vaccine Supply

2021-08-27 12:39:00

BioNTech SE agreed to evaluate the establishment of sustainable vaccine manufacturing capabilities in Rwanda and Senegal to support vaccine supply for the Member States of the African Union. Following the invitation of the kENUP Foundation, President Paul Kagame of Rwanda, President Macky Sall of Senegal, and President Ursula von der Leyen of the European Commission met Ugur Sahin, CEO and Co-Founder of BioNTech, in Berlin to discuss the development of sustainable vaccine production for Africa. The meeting resulted in a joint communiqué affirming BioNTech’s intention to manufacture mRNA vaccines arising from its Malaria and Tuberculosis vaccine development programs on the African continent. BioNTech has already started the evaluation of manufacturing capabilities, following the Company’s announcement of its aim to develop a well-tolerated and highly effective Malaria vaccine and to implement sustainable end-to-end vaccine supply solutions on the African continent. The decision to evaluate manufacturing solutions in Rwanda and Senegal follows the guidance of the African Union, the Africa Centres for Disease Control and Prevention (Africa CDC) and the African Medical Agency under formation. The prospective locations of the necessary manufacturing sites are expected to co-locate with the World Health Organization’s (WHO) upcoming Vaccine Hubs. These efforts will be aligned with the Team Europe Initiative on manufacturing and access to vaccines, medicines and medical technologies (MAV+) led by the European Commission in collaboration with the EU Member States.

Pfizer Inc. and BioNTech SE Announce Collaboration with Eurofarma Laboratórios SA to Manufacture COVID-19 Vaccine Doses for Latin America

2021-08-26 10:45:00

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with Eurofarma Laboratórios SA, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America. Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarma’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately. Per the agreement, Eurofarma will obtain drug product from facilities in the U.S., and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.Pfizer and BioNTech select contract manufacturers using a rigorous process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer Inc. and BioNTech SE Initiates Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY in Individuals 16 and Older

2021-08-25 16:08:00

Pfizer Inc. and BioNTech SE announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week. The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of COMIRNATY between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post-booster. The booster (third) dose of COMIRNATY elicited robust neutralizing antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection through one-month post-dose-three. SARS-CoV-2 50% neutralizing titers after the third dose were 3.3 times the titers after the second dose. The post-dose-three neutralizing titers met the prespecified 1.5-fold non-inferiority criterion for success and were statistically superior. Moreover, 99.5% of participants had a four-fold response after the third dose, compared to 98.0% after the second dose. The titers after dose three met the pre-specified 10% non-inferiority margin for the difference in the four-fold seroresponse rates. The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY. Pfizer and BioNTech intend to submit these data to a peer-reviewed journal, as well as file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming weeks. A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. Indication & Authorized Use: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to: prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

Citigroup Inc., China Investor Conference 2021- Shanghai, Nov 01, 2021 through Nov 03, 2021

2021-08-24 16:51:00

Citigroup Inc., China Investor Conference 2021- Shanghai, Nov 01, 2021 through Nov 03, 2021. Venue: Shanghai City, China.

BioNTech SE Presents at Bank of America Global Healthcare Conference, Sep-15-2021 06:40 AM

2021-08-22 01:10:00

BioNTech SE Presents at Bank of America Global Healthcare Conference, Sep-15-2021 06:40 AM. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.