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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
NEW YORK and MAINZ, GERMANY, November 20, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission is also supported by solicited safety data from a randomized subset of approximately 8,000 participants =18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine. “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” “Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency are of particular importance to us and we have continuously provided data to them as part of our rolling review process.” The companies have already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization. Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in our clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making. Manufacturing and Delivery Capabilities Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the U.S. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization). Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8°C) conditions. From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America, and South Africa. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorzation. About the Study Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. About Pfizer: Breakthroughs That Change Patients’ Lives Pfizer Disclosure Notice This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the submission of a request for Emergency Use Authorization and other regulatory submissions, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply), that involves 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 clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial 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 or in larger, more diverse populations upon commercialization; the risk that 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 data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any other biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, 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 or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine candidate’s ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; 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, 2019 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 BioNTech Forward-looking Statements Pfizer Contacts: Investor Relations BioNTech Contacts: Investor Relations |