BNTX BioNTech SE

414.44
+62.63  (+18%)
Previous Close 351.81
Open 361
52 Week Low 54.1
52 Week High 354.08
Market Cap $100,095,990,179
Shares 241,521,065
Float 241,521,065
Enterprise Value $80,579,893,176
Volume 13,666,732
Av. Daily Volume 2,832,381
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
BNT312/GEN1042
Solid tumors
Phase 1/2
Phase 1/2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
BNT411
Solid tumors
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BNT311 / GEN1046
Solid tumors
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BNT211
Solid tumors
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BNT162b2
COVID-19 vaccine
PDUFA priority review
PDUFA priority review
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
BNT131
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at SITC November 2020.
BNT111 and LIBTAYO (cemiplimab)
Melanoma
Phase 2
Phase 2
Phase 2 initiation of dosing announced June 18, 2021.
BNT122
Colorectal cancer
Phase 2
Phase 2
Phase 2 dosing to commence 2H 2021.
BNT142
Solid tumors
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
BNT141
Solid tumors
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
BNT113
Head and Neck Cancer / HPV
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
BNT151
Solid tumors
Phase 1
Phase 1
Phase 1 trial commenced dosing February 2021.
BNT114
Triple negative breast cancer
Phase 1
Phase 1
Phase 1 trial ongoing.
BNT122
Melanoma
Phase 2
Phase 2
Phase 2 enrollment slower than expected due to the impact of COVID-19 pandemic - noted November 10, 2020.
BNT112
Prostate cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial initiated December 2019.

Latest News

  1. Mainz, Germany, August 2, 2021 (GLOBE NEWSWIRE)BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter on Monday, August 9th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2021.

    The slide presentation and audio of the webcast will be available via this link.

    To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

    United States international:
    United States domestic (toll-free):
    Germany:

    Mainz, Germany, August 2, 2021 (GLOBE NEWSWIRE)BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter on Monday, August 9th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2021.

    The slide presentation and audio of the webcast will be available via this link.

    To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

    United States international:

    United States domestic (toll-free):

    Germany:

    Conference ID:
    +1 646 741 3167

    +1 877 870 9135

    +49 (0) 692 2222 625

    5378733

    Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company's website at https://biontech.de/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit www.BioNTech.de.

    BioNTech Contacts

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513



    Primary Logo

    View Full Article Hide Full Article
    • BioNTech aims to develop the first mRNA-based vaccine for Malaria prevention with the initiation of a clinical trial by end of 2022
    • BioNTech is evaluating sustainable mRNA vaccine production capacities in Africa; the Company's efforts are supported by the joint convening powers of the World Health Organization (WHO) and the Africa Centers for Disease Control and Prevention (Africa CDC)
    • BioNTech's Malaria project is part of the ‘eradicateMalaria' initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria

    MAINZ, Germany, July 26, 2021 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech"))) today announced the launch of its Malaria project, which aims to develop a well-tolerated and highly effective Malaria vaccine and implement…

    • BioNTech aims to develop the first mRNA-based vaccine for Malaria prevention with the initiation of a clinical trial by end of 2022
    • BioNTech is evaluating sustainable mRNA vaccine production capacities in Africa; the Company's efforts are supported by the joint convening powers of the World Health Organization (WHO) and the Africa Centers for Disease Control and Prevention (Africa CDC)
    • BioNTech's Malaria project is part of the ‘eradicateMalaria' initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria

    MAINZ, Germany, July 26, 2021 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech"))) today announced the launch of its Malaria project, which aims to develop a well-tolerated and highly effective Malaria vaccine and implement sustainable vaccine supply solutions on the African continent.

    BioNTech's Malaria project has two key objectives:

    First, the development of a safe and highly effective mRNA vaccine with durable protective immunity to prevent Malaria and disease-associated mortality. BioNTech will assess multiple vaccine candidates featuring known Malaria targets such as the circumsporozoite protein (CSP), as well as new antigens discovered in the pre-clinical research phase. The most promising mRNA vaccine candidates will be selected for clinical development. The start of the clinical trial for the first vaccine candidate is planned for the end of 2022. The Malaria vaccine development program is an extension of BioNTech's COVID-19 vaccine efforts. Building on two decades of mRNA research and its clinical stage mRNA platform, BioNTech has co-developed the first mRNA-based COVID-19 vaccine together with its partner Pfizer.

    The second objective is the development of sustainable vaccine production and supply solutions on the African continent. BioNTech is exploring possibilities to set up state-of-the-art mRNA manufacturing facilities, either with partners or on its own. The facilities are expected to manufacture various mRNA-based vaccines upon approval to ensure sustainable supply operations. BioNTech plans to co-locate its African manufacturing capabilities with the technology transfer hubs under development by the WHO, in alignment with the African manufacturing strategy created by the Africa CDC. This strategy aims to expand the capacity of low- and middle-income countries to manufacture contemporary vaccines end-to-end, and scale up production to increase global access.

    "The response to the pandemic has shown that science and innovation can transform people's lives when all key stakeholders work together towards a common goal. We are committed to bringing our innovations to those who need them most," said Prof. Dr. Ugur Sahin, CEO and co-founder of BioNTech. "We are more than grateful to be part of the joint efforts of the Eradicate Malaria project. Together with our partners, we will do whatever it takes to develop a safe and effective mRNA-based Malaria vaccine that will prevent the disease, reduce mortality and ensure a sustainable solution for the African continent and other regions affected by this disease. Our efforts will include cutting-edge research and innovation, significant investments in vaccine development, the establishment of manufacturing facilities, and the transfer of manufacturing expertise to production sites on the African continent and wherever else it is needed."

    BioNTech has undertaken comprehensive antigen discovery processes to identify antigens for various vaccine candidates. Since 2019, the Company has collaborated with the Bill and Melinda Gates foundation to develop Human Immunodeficiency Virus (HIV) and Tuberculosis programs and provide affordable access to vaccines to low- and middle-income countries. For Tuberculosis, BioNTech plans to begin clinical trials for testing a vaccine candidate in 2022, just about two years after the program was initiated. The antigen discovery processes for Malaria and Tuberculosis are being conducted by specialized teams at BioNTech's headquarters in Mainz. Currently, BioNTech and its partners are developing vaccines against nine different infectious diseases, and the Company continues to develop 15 oncology programs at clinical stage based on four different drug classes, including mRNA.

    The World Health Organization (WHO), European Commission and other organizations have been involved in the early planning phase of BioNTech's Malaria project and have offered their support to identify and set up the necessary infrastructure. Collaboration with the African Union and the Africa CDC under the partnership for African Vaccine Manufacturing programme will ensure that the enabling factors such as regulatory alignment and policy transfer, as well as country coordination are in place to get the vaccines from factories to the citizens of the African Union.

    BioNTech's Malaria project is part of the ‘eradicateMalaria' initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria. The kENUP Foundation is a non-profit public benefit foundation supporting research-based innovation in the wider health industries for societal benefit.

    About Malaria (source WHO)

    In 2019, according to the WHO, there were an estimated 229 million cases of malaria worldwide. The estimated number of malaria deaths stood at 409,000 in 2019. Children aged under 5 years are the most vulnerable group affected by malaria. In 2019, they accounted for 67% (274,000) of all malaria deaths worldwide. The WHO African Region carries a disproportionately high share of the global malaria burden. In 2019, 94% of malaria cases and deaths worldwide were reported on the African continent.

    About Tuberculosis (source WHO)

    In 2019, an estimated 10 million people fell ill with tuberculosis worldwide. A total of 1.4 million people died from tuberculosis in 2019 (including 208 000 people with HIV). Worldwide, tuberculosis is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). Eight countries account for two thirds of the total, with India leading the count, followed by Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, direct or indirect statements concerning: BioNTech's Malaria, Tuberculosis and HIV programs; timing for selecting clinical candidates for these programs and the commencement of a clinical trial, as well as any data readouts; the nature of the collaboration with the African Union and the Africa CDC; the nature and duration of support from WHO, the European Commission and other organizations with establishing infrastructure; the development of sustainable vaccine production and supply solutions on the African continent and the nature and feasibility of these solutions; the potential safety and efficacy of the product candidates; and BioNTech's anticipated market opportunity and size for its product candidates the rate and degree of market acceptance of BioNTech's investigational medicines, if approved. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies regarding timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials.

    For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    BioNTech Contacts:

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074



    Primary Logo

    View Full Article Hide Full Article
  2. The African continent carries a disproportionately high share of the global infectious disease burden. The extraordinary scientific progress made during the COVID-19 pandemic gives hope in addressing a range of life-threatening infectious diseases. The kENUP Foundation has been working with the World Health Organization, the Africa CDC, the European Commission, the European Investment Bank, BioNTech, and the Bill & Melinda Gates Foundation on sustainable solutions to infectious disease challenges on the continent.

    For a significant update on this work, the kENUP Foundation invites the public and media representatives to

    Fighting Infectious Diseases – Focus on Africa

    on

    July 26th, 16:00-17:30 CEST

    Speakers…

    The African continent carries a disproportionately high share of the global infectious disease burden. The extraordinary scientific progress made during the COVID-19 pandemic gives hope in addressing a range of life-threatening infectious diseases. The kENUP Foundation has been working with the World Health Organization, the Africa CDC, the European Commission, the European Investment Bank, BioNTech, and the Bill & Melinda Gates Foundation on sustainable solutions to infectious disease challenges on the continent.

    For a significant update on this work, the kENUP Foundation invites the public and media representatives to

    Fighting Infectious Diseases – Focus on Africa

    on

    July 26th, 16:00-17:30 CEST

    Speakers will include:

    • Dr Tedros Adhanom Ghebreyesus, Director-General WHO, and Dr Matshidiso Moeti, WHO Regional Director for Africa
    • Dr John Nkengasong, Director of the Africa Centres for Disease Control
    • Prof Dr Uğur Şahin and Dr Özlem Türeci, Co-Founders BioNTech SE
    • Dr Ursula von der Leyen, President European Commission
    • Dr Werner Hoyer, President European Investment Bank
    • Mark Suzman, CEO, Bill & Melinda Gates Foundation

    The event will be live-streamed via kENUP's website: https://www.kenup.eu/events and on some partners' digital channels. Media outlets have the permission to stream the event. Interpretation will be available for this event. Choices will include Arabic, Chinese, English, French, German, Hindi, Russian, Spanish and Portuguese.

    Journalists will have the opportunity to participate in a media Q&A session during the latter part of the event. Interested journalists can join using the following link:

    https://zoom.us/j/95583613249?pwd=TXRrYWtSYkZ4Qno2M1RPci9PTzFkdz09

    Passcode: 170662

     



     



    Primary Logo

    View Full Article Hide Full Article
    • Dose deliveries for new order expected to occur from October 2021 through April 2022

    NEW YORK AND MAINZ, GERMANY, July 23, 2021 Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies' COVID-19 vaccine for donation to the world's poorest nations.

    • Dose deliveries for new order expected to occur from October 2021 through April 2022

    NEW YORK AND MAINZ, GERMANY, July 23, 2021 Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies' COVID-19 vaccine for donation to the world's poorest nations.

    "As a long-term partner to the U.S. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "These additional doses will help the U.S. government ensure broad vaccine access into next year."

    "It has been our consistent goal to supply as many doses of our COVID-19 vaccine as possible to people around the world to help bring an end to this pandemic," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We are honored to support the U.S. and more than 100 countries in their continuing vaccination programs."

    The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The U.S. government also has the option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, if available and authorized.

    Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment for free access to COVID-19 vaccines.

    The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

    The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is 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. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

    AUTHORIZED USE IN THE U.S.:

    The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an 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 12 years of age and older.

    IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

    • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine
    • Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)
    • Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual's clinical circumstances
    • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
    • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
    • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
    • In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
    • Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials:
      • severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm)
      • myocarditis and pericarditis
    • Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
    • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
    • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
    • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
    • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report
    • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
    • Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Disclosure Notice

    The information contained in this release is as of July 23, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply to the U.S. government and the timing of delivery of doses thereunder, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

    BioNTech Forward-looking Statements

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

    For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Pfizer Contacts:

    Media Relations

    Amy Rose

    +1 (212) 733-7410

    Investor Relations

    Chuck Triano

    +1 (212) 733-3901

      

    BioNTech Contacts:

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513

     

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074

     



    Primary Logo

    View Full Article Hide Full Article
  3. Dose deliveries for new order expected to occur from October 2021 through April 2022

    Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies' COVID-19 vaccine for donation to the world's poorest nations.

    This press release features multimedia. View the…

    Dose deliveries for new order expected to occur from October 2021 through April 2022

    Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies' COVID-19 vaccine for donation to the world's poorest nations.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005094/en/

    "As a long-term partner to the U.S. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "These additional doses will help the U.S. government ensure broad vaccine access into next year."

    "It has been our consistent goal to supply as many doses of our COVID-19 vaccine as possible to people around the world to help bring an end to this pandemic," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We are honored to support the U.S. and more than 100 countries in their continuing vaccination programs."

    The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The U.S. government also has the option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, if available and authorized.

    Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment for free access to COVID-19 vaccines.

    The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

    The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is 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. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

    AUTHORIZED USE IN THE U.S.:

    The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an 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 12 years of age and older.

    IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

    • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine

      Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)
    • Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual's clinical circumstances
    • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
    • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
    • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
    • In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
    • Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials:
      • severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm)
      • myocarditis and pericarditis

        Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
    • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
    • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
    • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
    • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report
    • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
    • Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Disclosure Notice

    The information contained in this release is as of July 23, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply to the U.S. government and the timing of delivery of doses thereunder, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

    BioNTech Forward-looking Statements

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

    For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    View Full Article Hide Full Article
View All BioNTech SE News