- The updated COVID-19 vaccine is tailored to the Omicron JN.1
lineage of SARS-CoV-2 and is recommended for individuals 6 months
of age and older
- Recommendation is based on pre-clinical and epidemiological
data showing that the JN.1-adapted monovalent COVID-19 vaccine
generates an improved immune response against multiple JN.1
sublineages
- Doses will be ready to ship to applicable EU member states
immediately upon authorization by the European Commission
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 JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1)
for active immunization to prevent COVID-19 caused by SARS-CoV-2 in
individuals 6 months of age and older. The adaptation is based on
the recommendation from the World Health Organization (WHO)
Technical Advisory Group on COVID-19 Vaccine Composition and the
European Medicines Agency's Emergency Task Force (ETF) to update
COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the
2024-2025 vaccination campaign. ETF stated that “evidence indicates
that targeting JN.1 will help maintain the effectiveness of the
vaccines as SARS-CoV-2 continues to evolve.”1,2
The European Commission (EC) will review the CHMP’s
recommendation and is expected to make a final decision soon.
Following the EC decision, the updated vaccine will be available to
ship to applicable EU member states immediately. Pfizer and
BioNTech have been manufacturing the Omicron JN.1-adapted
monovalent COVID-19 vaccine at risk to ensure supply readiness
ahead of the upcoming fall and winter season when the demand for
COVID-19 vaccination is expected to increase.2
The CHMP’s recommendation is based on the full body of previous
clinical, non-clinical, and real-world evidence supporting the
safety and efficacy of the COVID-19 vaccines by Pfizer and
BioNTech. The application also included manufacturing and
pre-clinical data showing that the JN.1-adapted monovalent COVID-19
vaccine generates a substantially improved response against
multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other
currently circulating sublineages, compared with the companies’
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.3
Pfizer and BioNTech are starting rolling applications with the
U.S. Food and Drug Administration (FDA), per recent FDA
recommendation, requesting approval of their Omicron KP.2-adapted
monovalent COVID-19 vaccines for individuals 6 months of age and
older. The companies will continue to monitor the evolving
epidemiology of COVID-19 and make appropriate preparations to meet
global public health needs.
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 (COMIRNATY®
Original/Omicron BA.4/5; COMIRNATY® Omicron XBB.1.5) 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 receive
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.
*COMIRNATY (2023-2024 Formula) is made the same way as
Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and
Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the
spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5
(Omicron XBB.1.5).
- 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
for 15 minutes after receiving the vaccine
- People with weakened immune systems may have a reduced immune
response to COMIRNATY
- COMIRNATY may not protect all vaccine recipients
- 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 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
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
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 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
Pfizer-BioNTech COVID-19 Vaccine has not been approved or
licensed by FDA, but has been authorized for emergency use by FDA,
under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use
in individuals aged 6 months through 11 years of age. 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
- A person 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
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 (2023-2024 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.
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 June 27,
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
JN.1 lineage, including a submission to the European Medicines
Agency (EMA) for an Omicron-adapted monovalent COVID-19 vaccine,
based on the JN.1 lineage, 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 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 submission to the EMA
for an Omicron-adapted monovalent COVID-19 vaccine candidate, based
on the 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; 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 JN.1-adapted monovalent COVID-19 vaccine; qualitative
assessments of available data and expectations of potential
benefits, including the adapted vaccine’s response against multiple
Omicron JN.1 sublineages, including KP.2, KP.3 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 March 31, 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 World Health Organization (WHO) Statement on the antigen
composition of COVID-19 vaccines. 26April 2024. Available at:
https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines#:~:text=In%20May%202023%2C%20the%20TAG,1.5%2C%20as%20the%20vaccine%20antigen
(Accessed 26.06.2024). 2 European Medicines Agency (EMA) ETF
recommends updating COVID-19 vaccines to target new JN.1 variant.
30April 2024. Available at:
https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant
(Accessed 26.06.2024). 3 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 26.06.2024)
Category: Vaccines
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