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 https://www.globenewswire.com/Tracker?data=uIMy3rBfjWGxJ1f_FwZqSFZKG87-ZgucdGLY4PIS6VXye0I2oJBFrRlKdSwUz_UwMRijFLrV0P2bt_MzQSJ5ArNhZ1TwMg4NaCEp3SPqysl5jAdk9E3-fuv26wRRG7pBVo4JLHzWwB8ZnOBfKCmd7FJfzhEf4ZHlGMT6FccnSMhLDiudFOd2YNfcHljHAI7clEEQRreQn9aoG-8oAfRWiHvbiLKt8xjS4_-W1Hk0Fts= www.sec.gov and https://www.globenewswire.com/Tracker?data=uIMy3rBfjWGxJ1f_FwZqSPN0ZJQHa-6A_hoiH0j9SlweR0Ve3T4tkNf-hP35qMHGoMzGJM4klrES-WzIFfwIrHCauy7tDMNqH8-1PUG046IW5hmTvjNakCAldac9YXbmSuS6bmvDc5YZ_2IHFJu0PU3zlZzUGUZEvDu_-noljlhIRsiYdhRpyNdAi8zlu8TYXjFdowv8R1oN0r63dwnQXaYQr7w4NybEhH-6nnA5pKc= 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 including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including the approval of the BLA for BNT162b2 to prevent COVID-19 in individuals 16 years of age and older in the U.S., a potential submission of a supplemental BLA for a potential booster dose of BNT162b2 in individuals 16 years of age and older and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence, a BLA to support potential full FDA approval of BNT162b2 in individuals 12 through 15 years, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); 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

https://www.globenewswire.com/Tracker?data=dNJrOgQ4aKOs2I-VRYqkNdUUghhjjGWUAuJDsjKjAXcY4OwvAx89z34Q7MHEcCx9peAvqRDuL0Yn25dT-ezJXhtzJ4_001qljy2Lf4s9V6A= Amy.Rose@pfizer.com

Investor Relations

Christopher Stevo

+1 (212) 733-0437

https://www.globenewswire.com/Tracker?data=ArKsHnEl1rU-AslrtQgZHcXyIaHbt6GMh5rkxU_IdHiW3qbQJy8GFlFzmqwzEKZ5BIKlsq25TGVlXRlo9KubUIAwmJm_zV0UmJlAiLNy0ms5fAX5hzB1mHNP-rb1QHFx Christopher.Stevo@pfizer.com

BioNTech Contacts:

Media Relations

Jasmina Alatovic

+49 (0)6131 9084 1513

https://www.globenewswire.com/Tracker?data=Tm2o6zyvmf7BAEM01ned3W7zml5UCVPDPnyKdxyPjBNQafEcXxmA0YWOeDqRqtAiwF99WlXZ2rQ0t3G0-F9VFTYlhCWrwyUNbFECxX_W62g= Media@biontech.de

Investor Relations

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

https://www.globenewswire.com/Tracker?data=5R4s4p72EPJrewfz0mlywBDuG2Qw9jgqeivs6zZRzEEx3zzqLP31Gk_cYTaMGB4H3IPKhrNoP0kqTqfwHstD2alQiCla81grf8IJB1Ppxxo= Investors@biontech.de

(END) Dow Jones Newswires

August 23, 2021 11:55 ET (15:55 GMT)