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 
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   Pfizer Disclosure Notice 
 
   The information contained in this release is as of May 11, 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 potential of BNT162b2 for adolescents 12 to 15 
years of age, evaluation of BNT162b2 in children 6 months to 11 years 
old, 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 topline 
data outlined in this release), including the possibility of unfavorable 
new preclinical, clinical or safety data and further analyses of 
existing preclinical, clinical or safety data (including the topline 
data outlined in this release); 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 (including the topline data 
outlined in this release) 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 
(including the topline data outlined in this release) 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 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 
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 a potential 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; 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 
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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 
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

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May 11, 2021 02:30 ET (06:30 GMT)