NEW YORK and MAINZ, GERMANY, February 19, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) right this moment introduced the submission of latest information to the U.S. Meals and Drug Administration (FDA) demonstrating the steadiness of their COVID-19 vaccine when saved at -25°C to -15°C (-13°F to five°F), temperatures extra generally present in pharmaceutical freezers and fridges. The information have been submitted to the FDA to help a proposed replace to the U.S. Emergency Use Authorization (EUA) Prescribing Data, which might permit for vaccine vials to be saved at these temperatures for a complete of two weeks as a substitute or complement to storage in an ultra-low temperature freezer.
The FDA submission contains stability information generated on batches manufactured over the previous 9 months of COVID-19 vaccine improvement, from the batches that equipped the earliest scientific trials via the industrial scale batches at the moment in manufacturing. These information additionally will likely be submitted to international regulatory companies throughout the subsequent few weeks.
“We now have been constantly performing stability research to help the manufacturing of the vaccine at industrial scale, with the purpose of creating the vaccine as accessible as doable for healthcare suppliers and folks throughout the U.S. and around the globe,” mentioned Albert Bourla, Chairman and Chief Government Officer, Pfizer. “We recognize our ongoing collaboration with the FDA and CDC as we work to make sure our vaccine could be shipped and saved beneath more and more versatile circumstances. If accepted, this new storage possibility would supply pharmacies and vaccination facilities larger flexibility in how they handle their vaccine provide.”
“Our prime precedence was to shortly develop a protected and efficient vaccine and make it obtainable to probably the most weak individuals on the planet to be able to save lives. On the similar time, now we have constantly collected information that might allow storage at round -20°C. The information submitted might facilitate the dealing with of our vaccine in pharmacies and supply vaccination facilities a fair larger flexibility,” mentioned Ugur Sahin, CEO and Co-founder of BioNTech. “We are going to proceed to leverage our experience to develop potential new formulations that might make our vaccine even simpler to move and use.”
At present, the labels for the Pfizer-BioNTech COVID-19 Vaccine, together with the EUA label within the U.S., state that the vaccine have to be saved in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF). It might probably stay saved at these temperatures for as much as 6 months. The vaccines are shipped in a specially-designed thermal container that can be utilized as non permanent storage for a complete of as much as 30 days by refilling with dry ice each 5 days. Earlier than mixing with a saline diluent, the vaccine can also be refrigerated for as much as 5 days at normal fridge temperature, between 2⁰C and 8⁰C (36⁰F and 46⁰F). If accepted, the choice to retailer at -25°C to -15°C (-13°F to five°F) for 2 weeks can be along with this five-day choice to retailer at normal fridge temperature. The vaccine is run at room temperature by medical workers.
As further stability information are obtained, Pfizer and BioNTech anticipate the shelf life and/or expiration date might be prolonged, and alternate short-term temperature storage could also be thought-about.
The vaccine, which relies on BioNTech proprietary mRNA know-how, was developed by each BioNTech and Pfizer. BioNTech is the Advertising and marketing Authorization Holder within the European Union, and the holder of emergency use authorizations or equal in the US, United Kingdom, Canada and different nations prematurely of a deliberate utility for full advertising authorizations in these nations.
The Pfizer-BioNTech COVID19 Vaccine is permitted to be used beneath an Emergency Use Authorization (EUA) for lively immunization to forestall coronavirus illness 2019 (COVID-19) attributable to extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 16 years of age and older.
The Pfizer-BioNTech COVID-19 Vaccine has not been accepted or licensed by the U.S. Meals and Drug Administration (FDA), however has been approved for emergency use by FDA beneath an Emergency Use Authorization (EUA) to forestall Coronavirus Illness 2019 (COVID-19) to be used in people 16 years of age and older. The emergency use of this product is just approved all through the declaration that circumstances exist justifying the authorization of emergency use of the medical product beneath Part 564 (b) (1) of the FD&C Act except the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Truth Sheet for Healthcare Suppliers Administering Vaccine (Vaccination Suppliers) and Full EUA Prescribing Data obtainable at
IMPORTANT SAFETY INFORMATION:
Don’t administer Pfizer-BioNTech COVID-19 Vaccine to people with identified historical past of a extreme allergic response (e.g., anaphylaxis) to any part of the Pfizer-BioNTech COVID-19 Vaccine. Acceptable medical remedy used to handle fast allergic reactions have to be instantly obtainable within the occasion an acute anaphylactic response happens following administration of Pfizer- BioNTech COVID-19 Vaccine. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the prevalence of fast antagonistic reactions in keeping with the Facilities for Illness Management and Prevention tips (). Immunocompromised individuals, together with people receiving immunosuppressant remedy, might have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine might not defend all vaccine recipients. In scientific research, antagonistic reactions in members 16 years of age and older included ache on the injection web site (84.1%), fatigue (62.9%), headache (55.1%), muscle ache (38.3%), chills (31.9%), joint ache (23.6%), fever (14.2%), injection web site swelling (10.5%), injection web site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). Extreme allergic reactions, together with anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine throughout mass vaccination outdoors of scientific trials. Extra antagonistic reactions, a few of which can be critical, might change into obvious with extra widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
Out there information on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant girls are inadequate to tell vaccine-associated dangers in being pregnant.
Knowledge aren’t obtainable to evaluate the results of Pfizer-BioNTech COVID-19 Vaccine on the breastfed toddler or on milk manufacturing/excretion.
There aren’t any information obtainable on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with different COVID-19 vaccines to finish the vaccination collection. People who’ve obtained one dose of Pfizer-BioNTech COVID-19 Vaccine ought to obtain a second dose of Pfizer-BioNTech COVID-19 Vaccine to finish the vaccination collection.
Vaccination suppliers should report Hostile Occasions in accordance with the Truth Sheet to VAERS at http s:// or by calling 1-800-822-7967. The studies ought to embody the phrases “Pfizer-BioNTech COVID-19 Vaccine EUA” within the description part of the report.
Vaccination suppliers ought to assessment the Truth Sheet for Data to Present to Vaccine Recipients/Caregivers and Necessary Necessities for Pfizer-BioNTech COVID-19 Vaccine Administration Below Emergency Use Authorization.
Please see Emergency Use Authorization (EUA) Truth Sheet for Healthcare Suppliers Administering Vaccine (Vaccination Suppliers) together with Full EUA Prescribing Data obtainable at
About Pfizer: Breakthroughs That Change Sufferers’ Lives
At Pfizer, we apply science and our international assets to deliver therapies to individuals that stretch and considerably enhance their lives. We attempt to set the usual for high quality, security and worth within the discovery, improvement and manufacture of well being care merchandise, together with revolutionary medicines and vaccines. On daily basis, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, remedies and cures that problem probably the most feared ailments of our time. In keeping with our accountability as one of many world’s premier revolutionary biopharmaceutical firms, we collaborate with well being care suppliers, governments and native communities to help and broaden entry to dependable, reasonably priced well being care around the globe. For greater than 150 years, now we have labored to make a distinction for all who depend on us. We routinely put up data that could be essential to traders on our web site at As well as, to be taught extra, please go to us on and comply with us on Twitter at @Pfizer and @Pfizer Information, LinkedIn, YouTube and like us on Fb at
Pfizer Disclosure Discover
The data contained on this launch is as of February 19, 2021. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new data or future occasions or developments.
This launch comprises forward-looking details about Pfizer’s efforts to fight 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) (together with a proposed label replace to the U.S. EUA Prescribing Data which might allow the vaccine to be saved at -25°C to -15°C (-13°F to five°F), normal freezer temperature, for a complete of two weeks, qualitative assessments of accessible information, potential advantages, expectations for scientific trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and provide), involving substantial dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embody, amongst different issues, the uncertainties inherent in analysis and improvement, together with the power to satisfy anticipated scientific endpoints, graduation and/or completion dates for scientific trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to dangers related to preclinical and scientific information (together with the in vitro and Section Three information), together with the potential for unfavorable new preclinical, scientific or security information and additional analyses of current preclinical, scientific or security information; the power to supply comparable scientific or different outcomes, together with the speed of vaccine effectiveness and security and tolerability profile noticed up to now, in further analyses of the Section Three trial and extra research or in bigger, extra various populations upon commercialization; the power of BNT162b2 to forestall COVID-19 attributable to rising virus variants; the chance that extra widespread use of the vaccine will result in new details about efficacy, security, or different developments, together with the chance of further antagonistic reactions, a few of which can be critical; the chance that preclinical and scientific trial information are topic to differing interpretations and assessments, together with through the peer assessment/publication course of, within the scientific neighborhood usually, and by regulatory authorities; whether or not and when further information from the BNT162 mRNA vaccine program will likely be revealed in scientific journal publications and, in that case, when and with what modifications and interpretations; whether or not regulatory authorities will likely be glad with the design of and outcomes from these and any future preclinical and scientific research; whether or not and when the proposed replace to the U.S. EUA Prescribing Data could also be accepted; whether or not and when a Biologics License Software for BNT162b2 could also be filed within the U.S. and whether or not and when different biologics license and/or emergency use authorization purposes could also be filed specifically jurisdictions for BNT162b2 or every other potential vaccines which will come up from the BNT162 program, and if obtained, whether or not or when such emergency use authorization or licenses will expire or terminate; whether or not and when any purposes that could be pending or filed for BNT162b2 (together with a possible Biologics License Software within the U.S.) or different vaccines which will consequence from the BNT162 program could also be accepted by specific regulatory authorities, which is able to rely upon myriad components, together with making a willpower as as to whether the vaccine’s advantages outweigh its identified dangers and willpower of the vaccine’s efficacy and, if accepted, whether or not it will likely be commercially profitable; selections by regulatory authorities impacting labeling or advertising, manufacturing processes, security and/or different issues that might have an effect on the provision or industrial potential of a vaccine, together with improvement of merchandise or therapies by different firms; disruptions within the relationships between us and our collaboration companions or third-party suppliers; dangers associated to the provision of uncooked supplies to fabricate a vaccine; challenges associated to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration necessities, together with dangers associated to storage and dealing with after supply by Pfizer; the chance that we might not be capable of efficiently develop different vaccine formulations; the chance that we might not be capable of create or scale up manufacturing capability on a well timed foundation or keep entry to logistics or provide channels commensurate with international demand for our vaccine, which might negatively influence our skill to produce the estimated numbers of doses of our vaccine throughout the projected time intervals as beforehand indicated; whether or not and when further provide agreements will likely be reached; uncertainties relating to the power to acquire suggestions from vaccine technical committees and different public well being authorities and uncertainties relating to the industrial influence of any such suggestions; uncertainties relating to the influence of COVID-19 on Pfizer’s enterprise, operations and monetary outcomes; and aggressive developments.
An extra description of dangers and uncertainties could be present in Pfizer’s Annual Report on Type 10-Okay for the fiscal yr ended December 31, 2019 and in its subsequent studies on Type 10-Q, together with within the sections thereof captioned “Threat Components” and “Ahead-Wanting Data and Components That Could Have an effect on Future Outcomes”, in addition to in its subsequent studies on Type 8-Okay, all of that are filed with the U.S. Securities and Alternate Fee and obtainable at and
Biopharmaceutical New Applied sciences is a subsequent technology immunotherapy firm pioneering novel therapies for most cancers and different critical ailments. The Firm exploits a wide selection of computational discovery and therapeutic drug platforms for the speedy improvement of novel biopharmaceuticals. Its broad portfolio of oncology product candidates contains individualized and off-the-shelf mRNA-based therapies, revolutionary chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, focused most cancers antibodies and small molecules. Primarily based on its deep experience in mRNA vaccine improvement and in-house manufacturing capabilities, BioNTech and its collaborators are creating a number of mRNA vaccine candidates for a variety of infectious ailments alongside its various oncology pipeline. BioNTech has established a broad set of relationships with a number of international pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For extra data, please go to
BioNTech Ahead-looking Statements
This press launch comprises “forward-looking statements” of BioNTech throughout the that means of the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements might embody, however will not be restricted to, statements regarding: BioNTech’s efforts to fight COVID-19; the collaboration between BioNTech and Pfizer relating to a COVID-19 vaccine; our expectations relating to the potential traits of BNT162b2 in our Section 2/Three trial and/or in industrial use primarily based on information observations up to now; the power of BNT162b2 to forestall COVID-19 attributable to rising virus variants; the anticipated time level for added readouts on trial information of BNT162b2 in our Section 2/Three trial; the character of the scientific information, which is topic to ongoing peer assessment, regulatory assessment and market interpretation; the timing for submission of information for, or receipt of, any advertising approval or Emergency Use Authorization or potential label change; our contemplated delivery and storage plan, together with our estimated product shelf life at varied temperatures together with the information submitted to FDA; whether or not and when the proposed replace to the U.S. EUA Prescribing Data could also be accepted; challenges associated to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration necessities, together with dangers associated to storage and dealing with after supply by BioNTech; and the power of BioNTech to produce the portions of BNT162 to help scientific improvement and, if accepted, market demand, together with our manufacturing estimate for 2021. Any forward-looking statements on this press launch are primarily based on BioNTech present expectations and beliefs of future occasions, and are topic to numerous dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embody, however aren’t restricted to: the power to satisfy the pre-defined endpoints in scientific trials; competitors to create a vaccine for COVID-19; the power to supply comparable scientific or different outcomes, together with our said price of vaccine effectiveness and security and tolerability profile noticed up to now, within the the rest of the trial or in bigger, extra various populations upon commercialization; the power to successfully scale our productions capabilities; and different potential difficulties.
For a dialogue of those and different dangers and uncertainties, see BioNTech’s Quarterly Report for the Three and 9 Months Ended September 30, 2020, filed as Exhibit 99.2 to its Present Report on Type 6-Okay filed with the SEC on November 10, which is on the market on the SEC’s web site at All data on this press launch is as of the date of the discharge, and BioNTech undertakes no responsibility to replace this data except required by legislation.
Posted: February 2021
BNT162b2 (SARS-CoV-2 vaccine) FDA Approval Historical past