- Upon authorization by the European Commission (EC), the Omicron
KP.2-adapted COVID-19 vaccine will be available for individuals 6
months of age and older
- Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine
generates a substantially improved response against multiple
circulating Omicron JN.1 sublineages as did the Omicron
JN.1-adapted COVID-19 vaccine authorized by the European Commission
(EC) in July 2024
- Doses will be ready to ship to applicable European Union (EU)
member states as soon as possible upon European Commission (EC)
authorization
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX,
“BioNTech”) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has recommended marketing authorization for the companies’
Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2)
for active immunization to prevent COVID-19 caused by SARS-CoV-2 in
individuals 6 months of age and older. The European Commission will
review the CHMP’s recommendation and is expected to make a final
decision soon. Following the EC decision, Pfizer and BioNTech’s
Omicron KP.2-adapted COVID-19 vaccine will ship to European Union
(EU) member states that have specifically ordered this
formulation.
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the full release here:
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The CHMP recommendation dated September 19, 2024 is based on the
non-clinical and manufacturing data of the Omicron KP.2-adapted
vaccine and the clinical and real-world evidence supporting the
safety and efficacy of prior formulas of the COVID-19 vaccines by
Pfizer and BioNTech. The non-clinical data showed that the
KP.2-adapted vaccine generates a substantially improved response
against multiple currently circulating Omicron JN.1 sublineages,
including KP.2, LB.1, KP.3 and KP.3.1.1, compared with the
companies’ Omicron XBB.1.5-adapted COVID-19 vaccine.1
In July 2024, the EC granted marketing authorization for Pfizer
and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. This
authorization was based on evidence showing that the JN.1-adapted
COVID-19 vaccine generates a substantially improved response
against multiple Omicron JN.1 sublineages, including KP.2, LB.1,
KP.3 and KP.3.1.1, as compared with the companies’ Omicron
XBB.1.5-adapted COVID-19 vaccine.
Pending authorization of the Omicron KP.2-adapted vaccine by the
EC, both the Omicron KP.2-adapted vaccine and the Omicron
JN.1-adapted vaccine will be available across the EU, though
availability will vary based on individual country government
requests and national recommendations.
In the United States, the U.S. Food and Drug Administration
approved the companies’ Omicron KP.2-adapted COVID-19 vaccine for
individuals 12 years of age and older and granted emergency use
authorization for individuals 6 months through 11 years of age on
August 22, 2024. Pfizer and BioNTech will continue to monitor the
evolving epidemiology of COVID-19 and remain prepared to develop
modified vaccine formulas, as the data support and as regulatory
agencies recommend.
The COVID-19 vaccines (COMIRNATY®) 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 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’ 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
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 September 19, 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
Omicron-adapted monovalent COVID-19 vaccine candidate, based on the
KP.2 strain of the JN.1 lineage, including a positive Committee for
Medicinal Products for Human Use (CHMP) opinion for an Omicron
KP.2-adapted COVID-19 vaccine in the European Union, 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 any 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 BioNTech Biopharmaceutical 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 Statements This 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 KP.2-adapted monovalent
COVID-19 vaccine; qualitative assessments of available data and
expectations of potential benefits, including the adapted vaccine’s
response against multiple currently circulating Omicron JN.1
sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1; 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.
_______________________________ 1 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 23 August
2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240918153321/en/
Pfizer: Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 Media@biontech.de
Investor Relations Victoria Meissner, M.D.
Investors@biontech.de
Pfizer (NYSE:PFE)
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