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 potential COVID-19 vaccine, the BNT162 mRNA vaccine program, 
an agreement with Singapore to supply BNT162 and other potential 
agreements, and modRNA candidate BNT162b2 (including qualitative 
assessments of available data, potential benefits, expectations for 
clinical trials, 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 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 and additional studies 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 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 any biologics license and/or emergency use 
authorization applications may be filed in Singapore and any particular 
jurisdictions for BNT162b2 or any other potential vaccine candidates; 
whether and when any applications that may be pending or filed for 
BNT162b2 may be approved by particular regulatory authorities in 
Singapore, 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 
https://www.globenewswire.com/Tracker?data=EzrbO7eqj0eZeGlhXGo2zzw0SrjlLvocAwLnpCq6pj6v4f7gXGVcT_zyHMuYS7kps7qpsLiaUoNENKLOyZu0rA== 
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 
https://www.globenewswire.com/Tracker?data=EzrbO7eqj0eZeGlhXGo2z3MPv8GqcqAKb_OWCtSSH5UfWzXQLW13RIoUiKR9HWDCdLNrp0t4S6xlXAZXTxtEDw== 
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 regarding a 
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 trial data of BNT162b2 in our Phase 2/3 trial; 
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, if approved, market demand, including our production 
estimate 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 Contacts: 
 
   Global Media Relations Contact 
 
   Sharon Castillo 
 
   +1 202.624.6769 
 
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Sharon.Castillo@Pfizer.com 
 
   BioNTech Contacts: 
 
   Media Relations 
 
   Jasmina Alatovic 
 
   +49 89 62 81 75 46 
 
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Media@biontech.de 
 
   Investor Relations 
 
   Sylke Maas, Ph.D. 
 
   +49 (0)6131 9084 1074 
 
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Investors@biontech.de 
 
 
 
 
 
 

(END) Dow Jones Newswires

January 22, 2021 12:00 ET (17:00 GMT)