Pfizer-BioNTech COVID-19 Vaccine COMIRNATY Receives Full U.S. FDA Approval for Individuals 16 Years and Older

August 20, 2019 – Pharmaceutical –

The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). The EUA permitted essential
rollout of vaccine doses across the U.S. to help provide protection
during the COVID-19 public health emergency, based on initial data from
the pivotal Phase 3 clinical trial.

For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccineís high efficacy and favorable
safety profile were observed up to six months after the second dose.
The BLA submission package also included the manufacturing and
facilities data required for licensure. Pfizer and BioNTech completed
submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.

‘Based on the longer-term follow-up data that we submitted, todayís
decision by the FDA affirms the efficacy and safety profile of our
vaccine at a time when it is urgently needed. About 60 percent of
eligible Americans are fully vaccinated, and infection, hospitalization
and death rates continue to rise rapidly among unvaccinated populations
across the country,’ said Albert Bourla, Chairman and Chief Executive
Officer, Pfizer. ‘I am hopeful this approval will help increase
confidence in our vaccine, as vaccination remains the best tool we have
to help protect lives and achieve herd immunity. Hundreds of millions of
doses of our vaccine already have been administered in the U.S. since
December 2020, and we look forward to continuing to work with the U.S.
government to reach more Americans now that we have FDA approval.’

‘Today’s full approval by the FDA underlines the vaccine’s high efficacy
and favorable safety profile,’ said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. ‘Our companies have shipped more than one
billion doses worldwide, and we will continue to work tirelessly to
broaden the access to our vaccine and to be prepared for potential
emerging escape variants.’

As announced on August 16,
Pfizer and BioNTech plan to seek licensure of a third, or booster, dose
of COMIRNATY in individuals 16 years of age and older via a
supplemental BLA. The companies also intend to submit a supplemental BLA
to support potential full FDA approval of COMIRNATY in individuals 12
through 15 years of age once the required data out to six months after
the second vaccine dose are available. In the meantime, the vaccine
remains available to 12- to 15-year-olds under the Emergency Use Authorization (EUA) granted by the FDA on May 10, 2021. For individuals at least 12
years of age who have undergone solid organ transplantation, or who are
diagnosed with conditions that are considered to have an equivalent
level of immunocompromise, a third dose of the vaccine also remains available under EUA following an amendment by the FDA on August 12.

COMIRNATY, which is based on BioNTechís proprietary mRNA technology, was
developed by both BioNTech and Pfizer. BioNTech is the Marketing
Authorization Holder in the United States, the European Union and the
United Kingdom, and the holder of emergency use authorizations or
equivalents in the United States (jointly with Pfizer), Canada and other
countries. Submissions to pursue regulatory approvals in those
countries where emergency use authorizations or equivalent were
initially granted are planned.

Indication & Authorized Use

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

• It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
• It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
  • prevent COVID-19 in individuals 12 through 15 years, and
  • provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:

• prevent COVID-19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the
EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same
formulation and can be used interchangeably to provide the COVID-19
vaccination series. An individual may be offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to
prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by
FDA, but has been authorized by FDA under an Emergency Use Authorization
(EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in
individuals 12 years of age and older; and the emergency use of this
product is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of the
medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:

• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects the immune system
• are pregnant, plan to become pregnant, or are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection

The vaccine may not protect everyone.

Side effects reported with the vaccine include:

• There is a remote chance that the vaccine could cause a severe allergic reaction
  • A severe allergic reaction would usually occur within a few minutes to
    one hour after getting a dose of the vaccine. For this reason,
    vaccination providers may ask individuals to stay at the place where
    they received the vaccine for monitoring after vaccination
  • Signs of a severe allergic reaction can include difficulty breathing,
    swelling of the face and throat, a fast heartbeat, a bad rash all over
    the body, dizziness, and weakness
  • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
• Myocarditis (inflammation of the heart muscle) and pericarditis
  (inflammation of the lining outside the heart) have occurred in some
  people who have received the vaccine. In most of these people, symptoms
  began within a few days following receipt of the second dose of the
  vaccine. The chance of having this occur is very low. Individuals should
  seek medical attention right away if they have any of the following
  symptoms after receiving the vaccine:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart
• Side effects that have been reported with the vaccine include:
  • severe allergic reactions; non-severe allergic reactions such as rash,
    itching, hives, or swelling of the face; myocarditis (inflammation of
    the heart muscle); pericarditis (inflammation of the lining outside the
    heart); injection site pain; tiredness; headache; muscle pain; chills;
    joint pain; fever; injection site swelling; injection site redness;
    nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea;
    vomiting; arm pain
• These may not be all the possible side effects of the vaccine. Serious
  and unexpected side effects may occur. The vaccine is still being
  studied in clinical trials. Call the vaccination provider or healthcare
  provider about bothersome side effects or side effects that do not go
  away

There is no information on the use of the vaccine with other vaccines.

Patients should always ask their healthcare providers for medical advice
about adverse events. Individuals are encouraged to report negative
side effects of vaccines to the US Food and Drug Administration (FDA)
and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age).

About Pfizer: Breakthroughs That Change Patientsí Lives

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
our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of August 23, 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 Pfizerís efforts
to combat COVID-19, the collaboration between BioNTech and Pfizer to
develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and
COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the approval of
the BLA for BNT162b2 to prevent COVID-19 in individuals 16 years of age
and older in the U.S., a potential submission of a supplemental BLA for
a potential booster dose of BNT162b2 in individuals 16 years of age and
older, a potential supplemental BLA to support potential full FDA
approval of BNT162b2 in individuals 12 through 15 years, qualitative
assessments of available data, potential benefits, expectations for
clinical trials, the 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 Phase 3 data), including the possibility of unfavorable
new preclinical, clinical or safety data and further analyses of
existing preclinical, 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 preclinical 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 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 the potential supplemental BLAs will
be filed in any jurisdictions 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 the
potential supplemental BLAs 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 vaccineís benefits outweigh its known
risks and determination of the vaccineís 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 vaccineís 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, booster
doses or new variant-specific vaccines; 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 Pfizerís business, operations and
financial results; and competitive developments.

A further description of risks and uncertainties can be found in
Pfizerís 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 www.sec.gov and 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: BioNTechís efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer including the
program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine,
mRNA) (BNT162b2) (including the approval of the BLA for BNT162b2 to
prevent COVID-19 in individuals 16 years of age and older in the U.S., a
potential submission of a supplemental BLA for a potential booster dose
of BNT162b2 in individuals 16 years of age and older and/or a potential
booster dose of a variation of BNT162b2 having a modified mRNA
sequence, a BLA to support potential full FDA approval of BNT162b2 in
individuals 12 through 15 years, qualitative assessments of available
data, potential benefits, expectations for clinical trials, the
anticipated timing of regulatory submissions, regulatory approvals or
authorizations and anticipated manufacturing, distribution and supply);
our expectations regarding the potential characteristics of BNT162b2 in
our clinical trials and/or in commercial use based on data observations
to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging
virus variants; the expected time point for additional readouts on
efficacy data of BNT162b2 in our clinical trials; 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
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
BioNTechís Annual Report as Form 20-F for the Year Ended December 31,
2020, filed with the SEC on March 30, 2021, which is available on the
SECís 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.