Press Release : Pfizer and BioNTech Publish -2-

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   Pfizer Disclosure Notice 
 
   The information contained in this release is as of January 20, 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, the anticipated timing of regulatory submissions, 
regulatory approval or authorization 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 clinical data (including the in 
vitro and 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 and additional studies or in larger, more 
diverse populations upon commercialization; the ability of BNT162b2 to 
prevent COVID-19 caused by new 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 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; whether regulatory authorities will be 
satisfied with the design of and results from these and any future 
preclinical and clinical studies; whether and when a Biologics License 
Application for BNT162b2 may be filed in the U.S. and whether and when 
other biologics license and/or emergency use authorization applications 
may be filed in particular jurisdictions for BNT162b2 or any other 
potential vaccines; whether and when any other applications that may be 
pending or filed for BNT162b2 (including a potential Biologics License 
Application in the U.S.) 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, 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'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 our vaccine, which would negatively impact our 
ability to supply the estimated numbers of doses of our vaccine 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 
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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 
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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 
potential COVID-19 vaccine; our expectations regarding the potential 
characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial 
use based on data observations to date; the expected time point for 
additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; 
the nature of non-clinical and  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 Quarterly Report for the Three and Nine Months Ended 
September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 
6-K filed with the SEC on November 10, 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: 
 
   Media Relations 
 
   Amy Rose 
 
   [phone] 
 
   [e-mail] 
 
   Investor Relations 
 
   Chuck Triano 
 
   [phone] 
 
   [e-mail] 
 
   BioNTech: 
 
   Media Relations 
 
   Jasmina Alatovic 
 
   [phone] 
 
   [e-mail] 
 
   Investor Relations 
 
   Sylke Maas, Ph.D. 
 
   [phone] 
 
   [e-mail] 
 
 
 
 
 

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January 20, 2021 07:50 ET (12:50 GMT)