- The updated COVID-19 vaccine is tailored to the KP.2 strain of
the SARS-CoV-2 Omicron JN.1 lineage and is recommended for
individuals 6 months of age and older
- The KP.2 adaptation is based on FDA guidance, which stated that
KP.2 is the preferred strain for COVID-19 vaccines for the US
2024-2025 fall and winter season, if feasible
- Shipping will begin immediately to ensure robust supply and
rapid access of this season’s vaccine in pharmacies, hospitals, and
clinics across the country
NEW YORK and MAINZ, GERMANY, August 22,
2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE
(Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and
Drug Administration (“FDA”) has approved the supplemental Biologics
License Application for individuals 12 years of age and older
(COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use
authorization for individuals 6 months through 11 years of age
(Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron
KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season’s
vaccine is for use as a single dose for most individuals 5 years of
age and older. Individuals 5 years of age and older with certain
kinds of immunocompromise previously vaccinated with Pfizer and
BioNTech COVID-19 vaccines or children under the age of 5 who have
not already completed a three-dose series with previous formulas of
a COVID-19 vaccine may be eligible to receive additional doses.
The KP.2 adaptation is based on guidance from
the FDA, which stated that KP.2 is the preferred strain of the JN.1
lineage for COVID-19 vaccines for use in the U.S. during the
2024-2025 fall and winter season, if feasible.1 Staying up to date
on vaccinations in line with the Centers for Disease Control and
Prevention (“CDC”) recommendations remains important, particularly
in light of COVID-19 cases on the rise again.2 This season’s Pfizer
and BioNTech COVID-19 vaccine will begin shipping immediately and
be available in pharmacies, hospitals, and clinics across the U.S.
beginning in the coming days.
The approval is based on the full body of
previous clinical, non-clinical, and real-world evidence supporting
the safety and effectiveness of the COVID-19 vaccines by Pfizer and
BioNTech. The application also included manufacturing and
non-clinical data showing that the KP.2-adapted vaccine generates a
substantially improved response against currently circulating
Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared
with the companies’ Omicron XBB.1.5 adapted COVID-19 vaccine.3
The COVID-19 vaccines by Pfizer and BioNTech are
based on BioNTech’s proprietary mRNA technology and were developed
by both companies. BioNTech is the Marketing Authorization Holder
for COMIRNATY® and its adapted vaccines (COMIRNATY® (COVID-19
Vaccine, mRNA); COMIRNATY® Original/Omicron BA.1; COMIRNATY®
Original/Omicron BA.4-5; COMIRNATY® Omicron XBB.1.5; COMIRNATY®
JN.1; COMIRNATY® KP.2) in the United States, the European Union,
the United Kingdom, and other countries, and the holder of
emergency use authorizations or equivalents in the United States
(jointly with Pfizer) and other countries.
INDICATION, AUTHORIZED USE AND IMPORTANT
SAFETY INFORMATION
INDICATION COMIRNATY® (COVID-19
Vaccine, mRNA) is a vaccine for use in people 12 years of age and
older to protect against coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
- You should NOT get COMIRNATY® (COVID-19 Vaccine, mRNA) if you
had a severe allergic reaction to a previous dose of COMIRNATY or
any Pfizer-BioNTech COVID-19 vaccine or to any ingredient in these
vaccines
- There is a remote chance that COMIRNATY could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to 1 hour after getting a dose. For this
reason, your vaccination provider may ask you to stay at the place
where you received the vaccine for monitoring after vaccination.
Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received mRNA COVID-19 vaccines, including
COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and
pericarditis following COMIRNATY have occurred most commonly in
adolescent males 12 through 17 years of age. In most of these
individuals, symptoms began within a few days following
vaccination. The chance of having this occur is very low. You
should seek medical attention right away if you or your child have
any of the following symptoms after receiving the vaccine,
particularly during the 2 weeks after receiving a dose of the
vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding
heart
- Fainting can happen after getting injectable vaccines including
COMIRNATY. Your vaccination provider may ask you to sit or lie
down
- People with weakened immune systems may have a reduced immune
response to COMIRNATY
- COMIRNATY may not protect all people who receive the
vaccine
Before getting COMIRNATY, tell your vaccination provider
about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose
of any COVID-19 vaccine
- 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 your
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
Additional side effects that have been reported with COMIRNATY
or Pfizer-BioNTech COVID-19 vaccines include:
- Non-severe allergic reactions such as rash, itching, hives, or
swelling of the face
- Injection site reactions: pain, swelling, redness, arm
pain
- General side effects: tiredness, headache, muscle pain, chills,
joint pain, fever, nausea, feeling unwell, lymph nodes
(lymphadenopathy), decreased appetite, diarrhea, vomiting,
dizziness
These may not be all the possible side effects of COMIRNATY. Ask
your healthcare provider about any side effects that concern
you.
You may report side effects to the FDA/CDC
Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free
number is 1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html.In addition, you can report side
effects to Pfizer Inc. at 1-800-438-1985 or
www.pfizersafetyreporting.com
Please click here for full Prescribing
Information and Patient Information for COMIRNATY. If it is not
currently available via these links, it will be visible as soon as
possible as we work to finalize the documents. Please check back
for the full information shortly.
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine
(2024-2025 Formula)* is FDA authorized under Emergency Use
Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) in individuals 6 months through 11 years of
age.*Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine.
EMERGENCY USE AUTHORIZATION
Emergency uses of COVID-19 vaccines from
BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine
(2024-2025 Formula), have not been approved or licensed by FDA, but
have been authorized by FDA, under an Emergency Use Authorization
(EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals
6 months of age and older. Emergency uses are only authorized for
the duration of the declaration that circumstances exist justifying
the authorization of emergency use of the medical products under
Section 564(b)(1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see EUA Fact
Sheets at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATION
- Your child should NOT get Pfizer-BioNTech COVID-19
Vaccine if they had a severe allergic reaction after a previous
dose of any Pfizer-BioNTech COVID-19 vaccine or to any ingredients
in these vaccines
- 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, the vaccination provider may ask you to
stay at the place where you received the vaccine for monitoring
after vaccination. If your child experiences a severe allergic
reaction, call 9-1-1, or go to the nearest hospital. 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, or dizziness and
weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received mRNA COVID-19 vaccines. Myocarditis
and pericarditis following Pfizer-BioNTech COVID-19 vaccines have
occurred most commonly in adolescent males 12 through 17 years of
age. In most of these individuals, symptoms began within a few days
following vaccination. The chance of having this occur is very low.
Seek medical attention right away if your child has any of the
following symptoms after receiving the vaccine, particularly during
the 2 weeks after receiving a dose of the vaccine:
- Chest pain
- Shortness of breath or difficulty breathing
- Feelings of having a fast-beating, fluttering, or pounding
heart
Additional symptoms, particularly in children, may include:
-
- Fainting
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Persistent vomiting
- Persistent pain in the abdomen
- Unusual and persistent cool, pale skin
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine. For this reason, your
vaccination provider may ask you to stay at the place where you
received the vaccine for monitoring after vaccination
- People with weakened immune systems may have a reduced immune
response to Pfizer- BioNTech COVID-19 Vaccine
- Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
- Tell your vaccination provider about all of your child’s
medical conditions, including if your child:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or is on a blood thinner
- is immunocompromised or is on a medicine that affects the
immune system
- is pregnant or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
- Side effects that have been reported with Pfizer-BioNTech
COVID-19 vaccines 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/tenderness
- Tiredness
- Headache
- Muscle pain
- Arm pain
- Fainting in association with injection of the vaccine
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Dizziness
- Irritability
- Febrile seizures (convulsions during a seizure)
These may not be all the possible side effects. Serious and
unexpected side effects may occur. Call the vaccination provider or
healthcare provider about bothersome side effects or side effects
that do not go away.
Report vaccine side effects to the US Food and
Drug Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll- free number is 1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech
COVID-19 Vaccine (2024-2025 Formula) EUA” in the first line of box
#18 of the report form.
In addition, individuals can report side effects
to Pfizer Inc. at www.pfizersafetyreporting.com or by calling
1-800-438-1985.
Please click here for Pfizer-BioNTech COVID-19
Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and
Caregiver EUA Fact Sheet. If it is not currently available via
these links, it will be visible as soon as possible as we work to
finalize the documents. Please check back for the full information
shortly.
About Pfizer: Breakthroughs That Change
Patients’ LivesAt 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 175 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 X 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 22, 2024. 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 COVID-19
vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech
COVID-19 Vaccine, also known as COMIRNATY® (COVID-19 Vaccine, mRNA)
(BNT162b2) including an approval in the U.S. for a COVID-19 vaccine
tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage,
submissions pending with other regulatory authorities, expectations
regarding the demand for COVID-19 vaccines, planned regulatory
submissions, qualitative assessments of available data, potential
benefits, expectations for clinical trials, potential regulatory
submissions, the anticipated timing of data readouts, regulatory
submissions, regulatory approvals or authorizations and anticipated
availability, 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
Phase 1/2/3 or Phase 4 data), including the data discussed in this
release for BNT162b2, any monovalent or bivalent vaccine candidates
or any other vaccine candidate in the BNT162 program in any of our
studies in pediatrics, adolescents, or adults or real world
evidence, 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,
in real world data studies or in larger, more diverse populations
following commercialization; the ability of BNT162b2, any
monovalent or bivalent vaccine candidates or any future vaccine 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 submissions to request emergency use or conditional marketing
authorizations for BNT162b2 in additional populations, for a
potential booster dose for BNT162b2, any monovalent or bivalent
vaccine candidates or any potential future vaccines (including
potential future annual boosters or re-vaccination), and/or other
biologics license and/or emergency use authorization applications
or amendments to any such applications may be filed in particular
jurisdictions for BNT162b2, 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, and if obtained, whether or when such
emergency use authorizations or licenses will expire or terminate;
whether and when any applications that may be pending or filed for
BNT162b2 (including any requested amendments to the emergency use
or conditional marketing authorizations), any monovalent or
bivalent vaccine candidates (including the submissions to
regulatory authorities for the COVID-19 vaccine tailored to the
KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage), 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; the risk that demand for any
products may be reduced or no longer exist or not meet expectations
which may lead to reduced revenues or excess inventory on-hand
and/or in the channel which, for our COVID-19 vaccine, resulted in
significant inventory write-offs in 2023 and could continue to
result in inventory write-offs, or other unanticipated charges;
challenges related to the transition to the commercial market for
our COVID-19 vaccine; uncertainties related to the public’s
adherence to vaccines, boosters, treatments or combinations; risks
related to our ability to accurately predict or achieve our revenue
forecasts for our COVID-19 vaccine or any potential future COVID-19
vaccines; potential third-party royalties or other claims related
to our COVID-19 vaccine; the risk that other companies may produce
superior or competitive products; risks related to the availability
of raw materials to manufacture or test a vaccine; 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; 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 vaccines or combination
vaccines; the risk that we may not be able to maintain 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
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, 2023 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 BioNTechBiopharmaceutical New
Technologies (BioNTech) is a global next generation immunotherapy
company pioneering novel therapies for cancer and other serious
diseases. BioNTech 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 and specialized pharmaceutical collaborators, including
Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the
Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron. For more information, please
visit www.BioNTech.com.
BioNTech Forward-looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements concerning:
BioNTech’s efforts to combat COVID-19; the collaboration between
BioNTech and Pfizer; the rate and degree of market acceptance of
BioNTech’s COVID-19 vaccine, including the Omicron JN.1-adapted
(including the KP.2 strain of the SARS-CoV-2 Omicron JN.1
sublineage) monovalent COVID-19 vaccine; qualitative
assessments of available data and expectations of potential
benefits, including the adapted vaccine’s response against Omicron
JN.1 sublineages, including KP.2 and other currently circulating
sublineages; regulatory submissions and regulatory approvals or
authorizations and expectations regarding manufacturing,
distribution and supply; expectations regarding anticipated changes
in COVID-19 vaccine demand, including changes to the ordering
environment; and expected regulatory recommendations to adapt
vaccines to address new variants or sublineages. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond BioNTech’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements. These risks and uncertainties
include, but are not limited to: 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 data discussed in this
release, and including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety data; the nature of the
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; BioNTech’s pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech’s initial sales to
national governments; the future commercial demand and medical need
for initial or booster doses of a COVID-19 vaccine; the
availability of raw materials to manufacture a vaccine; our
vaccine’s formulation, dosing schedule and attendant storage,
distribution and administration requirements, including risks
related to storage and handling after delivery; competition from
other COVID-19 vaccines or related to BioNTech’s other product
candidates, including those with different mechanisms of action and
different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; 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; the timing of and
BioNTech’s ability to obtain and maintain regulatory approval for
BioNTech’s product candidates; the ability of BioNTech’s COVID-19
vaccines to prevent COVID-19 caused by emerging virus variants;
BioNTech’s and its counterparties’ ability to manage and source
necessary energy resources; BioNTech’s ability to identify research
opportunities and discover and develop investigational medicines;
the ability and willingness of BioNTech’s third-party collaborators
to continue research and development activities relating to
BioNTech’s development candidates and investigational medicines;
the impact of the COVID-19 pandemic on BioNTech’s development
programs, supply chain, collaborators and financial performance;
unforeseen safety issues and potential claims that are alleged to
arise from the use of BioNTech’s COVID-19 vaccine and other
products and product candidates developed or manufactured by
BioNTech; BioNTech’s and its collaborators’ ability to
commercialize and market BioNTech’s COVID-19 vaccine and, if
approved, its product candidates; BioNTech’s ability to manage its
development and expansion; regulatory developments in the United
States and other countries; BioNTech’s ability to effectively scale
BioNTech’s production capabilities and manufacture BioNTech’s
products, including BioNTech’s target COVID-19 vaccine production
levels, and BioNTech’s product candidates; risks relating to the
global financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech's Report on
Form 6-K for the period ended June 30, 2024, and in subsequent
filings made by BioNTech with the SEC, which are available on the
SEC’s website at www.sec.gov. These forward-looking statements
speak only as of the date hereof. Except as required by law,
BioNTech disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release in the event of new information, future developments or
otherwise.
CONTACTS PfizerMedia Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTechMedia Relations Jasmina Alatovic +49 (0)6131 9084
1513 Media@biontech.de
Investor Relations Victoria Meissner, M.D.
Investors@biontech.de
--------
1 U.S. Food and Drug Administration (FDA).
Updated COVID-19 Vaccines for Use in the United States Beginning in
Fall 2024. 13 June 2024. Available at:
https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
(Accessed 28.06.2024).2 Centers for Disease Control and Prevention.
Available at CDC Recommends Updated 2024-2025 COVID-19 and Flu
Vaccines for Fall/Winter Virus Season | CDC Online Newsroom | CDC3
Vaccines and Related Biological Products Advisory Committee June 5,
2024 Meeting Presentation- Pfizer/BioNTech Clinical and Preclinical
Supportive Data 2024-2025 COVID19 Vaccine Formula.
https://www.fda.gov/media/179144/download (Accessed
28.06.2024).
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