Pfizer and BioNTech Request Regulatory Agencies Expand
Emergency Use of Their COVID-19 Vaccine to AdolescentsNEW YORK and MAINZ, GERMANY, April 9, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech
SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization(EUA) of the Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15
years of age. The companies plan to request similar rulings by other regulatory authorities
worldwide in coming days. These requests are based on data from the pivotal Phase 3 trial inadolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which
demonstrated 100 percent efficacy and robust antibody response after vaccination with theCOVID-19 Vaccine.
Topline results from an efficacy analysis on 12 to 15 year old participants through cases accuredby March 31, 2021 from the Phase 3 trial were recently announced. In this analysis, BNT162b2
was well tolerated with side effects generally consistent with those observed in participants 16 to25 years of age. All participants in the trial will continue to be monitored for long-term protection
and safety for an additional two years after their second dose.
These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support
governments in broadening global vaccination efforts. The companies look forward to working
closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory
authorities as part of the companies’ efforts to expand emergency or conditional authorization of
their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible.
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA
technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing
Authorization Holder in the European Union, and the holder of emergency use authorizations orequivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries
in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Foodand Drug Administration (FDA), but has been authorized for emergency use by FDA under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use
in individuals 16 years of age and older. The emergency use of this product is only authorized forthe 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 isterminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact
Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA
Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use
Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16years of age and older.
1

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATIONPRESCRIBING INFORMATION:• Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of asevere allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID19 Vaccine.
• Appropriate medical treatment used to manage immediate allergic reactions must be
immediately available in the event an acute anaphylactic reaction occurs following
administration of Pfizer- BioNTech COVID-19 Vaccine.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse
reactions according to the Centers for Disease Control and Prevention guidelines(https://www.cdc.gov/vaccines/covid-19/).
• Immunocompromised persons, including individuals receiving immunosuppressant therapy,
may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
• The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
• In clinical studies, adverse reactions in participants 16 years of age and older included painat the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills(31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site
redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
• Severe allergic reactions, including anaphylaxis, have been reported following the PfizerBioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.
• Additional adverse reactions, some of which may be serious, may become apparent with morewidespread use of the Pfizer-BioNTech COVID-19 Vaccine.
• Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are
insufficient to inform vaccine-associated risks in pregnancy.
• Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on thebreastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19
Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who
have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second doseof Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.
• Vaccination providers must report Adverse Events in accordance with the Fact Sheet toVAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports
should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description sectionof the report.
• Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine
Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization.
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information
available at www.cvdvaccine-us.com.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend andsignificantly improve their lives. We strive to set the standard for quality, safety and value in thediscovery, development and manufacture of health care products, including innovative medicinesand vaccines. Every day, Pfizer colleagues work across developed and emerging markets toadvance 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
2

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 April 9, 2021. Pfizer assumes no obligation toupdate forward-looking statements contained in this release as the result of new information orfuture events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, thecollaboration 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, 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 materiallyfrom 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 analysesof 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 thePhase 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, someof 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 andclinical 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 theemergency use or conditional marketing authorizations) or other vaccines that may result fromthe 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 outweighits known risks and determination of the vaccine’s efficacy and, if approved, whether it will becommercially successful; decisions by regulatory authorities impacting labeling or marketing,manufacturing processes, safety and/or other matters that could affect the availability orcommercial potential of a vaccine, including development of products or therapies by othercompanies; disruptions in the relationships between us and our collaboration partners or thirdparty suppliers; 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 andattendant storage, distribution and administration requirements, including risks related to storage
3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 estimatednumbers of doses of our vaccine within the projected time periods as previously indicated;
whether and when additional supply agreements will be reached; uncertainties regarding theability to obtain recommendations from vaccine technical committees and other public healthauthorities 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, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information andFactors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all ofwhich are filed with the U.S. Securities and Exchange Commission and availableat www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneeringnovel therapies for cancer and other serious diseases. The Company exploits a wide array ofcomputational discovery and therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized andoff-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specificcheckpoint 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 thePrivate 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; thecollaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential
second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2
having a modified mRNA sequence); our expectations regarding the potential characteristics of
BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; theability 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 theclinical 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 UseAuthorization; 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 tosupport 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 suchforward-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 in4

larger, more diverse populations upon commercialization; the ability to effectively scale ourproductions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on
Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, whichis available on the SEC’s website at www.sec.gov. All information in this press release is as ofthe date of the release, and BioNTech undertakes no duty to update this information unlessrequired by law.
Pfizer Contacts:
Media Relations
Amy Rose+1 (212) 733-7410
Amy.Rose@pfizer.com
Investor Relations
Chuck Triano+1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations
Jasmina Alatovic+49 (0)6131 9084 1513
Media@biontech.deInvestor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de5