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manufacturing, supply and distribution, including, among others, 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 pre-clinical or clinical data (including the Phase 3
data for BNT162b2), including the possibility of unfavorable new pre-clinical, clinical or safety data
and further analyses of existing pre-clinical, clinical or safety 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 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 pre-clinical and 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 or other programs 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 pre-clinical and clinical studies; whether and when a Biologics License Application (BLA) for
BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or
emergency use authorization (EUA) 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 EUA or licenses will expire or terminate;
whether and when any applications that may be pending or filed for BNT162b2 (including a
potential BLA 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, including our relationship with
BioNTech; the risk that other companies may produce superior or competitive products; the risk that
demand for any products may be reduced or no longer exist; risks related to the availability of raw
materials to manufacture or test any such products; challenges related to our vaccine’s ultra-low
temperature formulation, two-dose schedule and attendant storage, distribution and administration