• the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business,
operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales
and marketing, research and development and clinical trials;
• risks and uncertainties related to our efforts to develop and commercialize our COVID-19 products, as well as challenges
related to their 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 and clinical data (including Phase 1/2/3 or Phase 4 data for Comirnaty, the Pfizer-BioNTech COVID-19
bivalent vaccine, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the
BNT162 program or Paxlovid or any future COVID-19 treatment) in any of our studies in pediatrics, adolescents or
adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further
analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical,
clinical or safety data, including by audit or inspection; the ability to produce comparable clinical or other results for
Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine, any monovalent, bivalent or variant-adapted vaccine
candidates or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or
any other COVID-19 program, including the rate of effectiveness and/or efficacy, safety and tolerability profile observed
to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real-world data studies
or in larger, more diverse populations following commercialization; the ability of Comirnaty, the Pfizer-BioNTech
COVID-19 bivalent vaccine, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to
prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus
variants; the risk that more widespread use of Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine or Paxlovid
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,
Paxlovid or other COVID-19 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
existing or future pre-clinical and clinical studies; whether and when submissions to request emergency use or
conditional marketing authorizations for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine, or any future
vaccines in additional populations, for a potential booster dose for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent
vaccine, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future
annual boosters or re-vaccinations), and/or biologics license and/or EUA applications or amendments to any such
applications may be filed in particular jurisdictions for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine,
any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program,
including a potential variant-based, higher dose, or bivalent vaccine or any other potential vaccines, and if obtained,
whether or when such EUA or licenses will expire or terminate; whether and when submissions to request emergency
use or conditional marketing authorizations for Paxlovid or any future COVID-19 treatment and/or any drug applications
and/or EUA applications or amendments to any such applications for any indication for Paxlovid or any future
COVID-19 treatment may be filed in particular jurisdictions, and if obtained, whether or when such EUA or licenses will
expire or terminate; whether and when any application that may be pending or filed for Comirnaty, the Pfizer-BioNTech
COVID-19 bivalent vaccine, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may
result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program may be
approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as
to whether the vaccine’s or drug’s benefits outweigh its known risks and determination of the vaccine’s or drug’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 or drug, including the authorization or approval of products or therapies developed 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, no longer exist or not meet expectations
which may lead to excess inventory on-hand and/or in the channel or reduced revenues; challenges related to a transition
to the commercial market for any of the products; risks related to the availability of raw materials to manufacture or test
any such products; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution
and administration requirements, including risks related to storage and handling after delivery by Pfizer; challenges and
risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-
administration errors; the risk that we may not be able to successfully develop other vaccine formulations, booster doses
or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines or next generation
COVID-19 treatments; uncertainties related to vaccine adherence; the risk that we may not be able to recoup costs
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