Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron
JN.1-adapted COVID-19 Vaccine in the European Union
-
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
NEW YORK and MAINZ, Germany, June 27,
2024 — 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.3
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.4
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.
AUTHORIZED USE IN THE
EU:COMIRNATY® ▼ has been granted standard marketing
authorization (MA) by the European Commission to prevent
coronavirus disease 2019 (COVID-19) in people from the age of 6
months. The vaccine is administered as a single dose in people 5
years of age and older, and as a three-dose series, in infants and
children from 6 months to 4 years who have not had COVID-19 with
the first two doses are given three weeks apart, followed by a
third dose given at least 8 weeks after the second dose. Adults and
adolescents from the age of 12 are given 30 micrograms per dose;
children aged 5 to 11 years are given 10 micrograms per dose;
infants and children aged 6 months to 4 years are given 3
micrograms per dose. Additional doses may be administered to
individuals aged 5 years and older who are severely
immunocompromised in accordance with national recommendations. The
European Medicines Agency’s (EMA’s) Committee for Medicinal
Products for Human Use (CHMP) has completed its rigorous evaluation
of COMIRNATY, concluding by consensus that sufficiently robust data
on the quality, safety and efficacy of the vaccine are
available.
In addition, COMIRNATY has also been granted
standard MA for two adapted vaccines: COMIRNATY Original/Omicron
BA.4-5, which contains mRNA encoding for the spike protein of the
wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2;
and COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the
spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2.
COMIRNATY Omicron XBB.1.5 may be administered as
a single dose regardless of prior vaccination status in people aged
5 years and older. Children from 6 months to 4 years of age may
have one or three doses depending on whether they have completed a
primary vaccination course or have had COVID-19. There should be an
interval of at least 3 months between administration of COMIRNATY
Original/Omicron BA.4-5 or COMIRNATY Omicron XBB.1.5 and the last
prior dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
- Events of anaphylaxis have been reported. Appropriate medical
treatment and supervision should always be readily available in
case of an anaphylactic reaction following the administration of
the vaccine.
- There is an increased, but very rare risk (<1/10,000 cases)
of myocarditis and pericarditis following vaccination with
COMIRNATY. These conditions can develop within just a few days
after vaccination and have primarily occurred within 14 days. They
have been observed more often after the second vaccination, and
more often in younger males. Available data indicate that most
cases recover. Some cases required intensive care support and fatal
cases have been observed.
- From post-marketing experience very rare adverse reactions of
myocarditis and pericarditis, uncommon incidence of insomnia,
hyperhidrosis and night sweats, dizziness; common incidence of
vomiting, very common diarrhoea and unknown incidence (cannot be
estimated from available data) of anaphylaxis, paraesthesia,
hypoaesthesia and erythema multiforme, extensive swelling of
vaccinated limb, facial swelling (in vaccine recipients with a
history of injection of dermatological fillers) and heavy menstrual
bleeding (most cases appeared to be non-serious and temporary in
nature) have been identified.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation or stress‐related reactions (e.g.
dizziness, palpitations, increases in heart rate, alterations in
blood pressure, paresthesia, hypoesthesia and sweating) may occur
in association with the vaccination process itself. Stress-related
reactions are temporary and resolve on their own. Individuals
should be advised to bring symptoms to the attention of the
vaccination provider for evaluation. It is important that
precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from
acute severe febrile illness or acute infection. The presence of a
minor infection and/or low-grade fever should not delay
vaccination.
- As with other intramuscular injections, the vaccine should be
given with caution in individuals receiving anticoagulant therapy
or those with thrombocytopenia or any coagulation disorder (such as
haemophilia) because bleeding or bruising may occur following an
intramuscular administration in these individuals.
- The efficacy, safety and immunogenicity of the vaccine has not
been assessed in immunocompromised individuals, including those
receiving immunosuppressant therapy. The efficacy of COMIRNATY
Omicron XBB.1.5 may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY Omicron XBB.1.5
may not protect all vaccine recipients. Individuals may not be
fully protected until 7 days after their vaccination.
- Adverse reactions observed during clinical studies and
identified after post authorization experience are listed below
according to the following frequency categories: Very common (≥
1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to <
1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (<
1/10,000).
- Very common side effects: injection site pain, injection site
swelling, fever, chills, fatigue, headache, muscle pain, joint
pain, diarrhea.
- Common side effects: injection site redness, nausea, vomiting,
enlarged lymph nodes (more frequently observed after a booster
dose).
- Uncommon side effects: feeling unwell, arm pain, insomnia,
dizziness, injection site itching, allergic reactions such as rash,
itching, feeling weak or lack of energy/sleepy, decreased appetite,
excessive sweating, night sweats.
- Rare side effects: temporary one-sided facial drooping,
allergic reactions such as hives or swelling of the face.
- Very rare side effects: inflammation of the heart muscle
(myocarditis) or inflammation of the lining outside the heart
(pericarditis), which can result in breathlessness, palpitations or
chest pain.
- Not known incidence (cannot be estimated from the available
data): anaphylaxis, extensive swelling of vaccinated limbs; facial
swelling, pins and needles/tingling, reduced sense of touch or
sensation, a skin reaction that causes red spots or patches on the
skin, heavy menstrual bleeding.
- A large amount of observational data from pregnant women
vaccinated with the initially approved COMIRNATY vaccine during the
second and third trimester have not shown an increase in adverse
pregnancy outcomes. While data on pregnancy outcomes following
vaccination during the first trimester are presently limited, no
increased risk for miscarriage has been seen. No data are available
yet regarding the use of COMIRNATY Omicron XBB.1.5 during
pregnancy. Based on data available with other vaccine variants,
COMIRNATY Omicron XBB.1.5 can be used during pregnancy.
- No data are available yet regarding the use of COMIRNATY
Omicron XBB.1.5 during breast-feeding. Observational data from
women who were breast-feeding after vaccination with the initially
approved COMIRNATY vaccine have not shown a risk for adverse
effects in breast-fed newborns/infants. COMIRNATY Omicron XBB.1.5
can be used during breast-feeding.
- Interactions with other medicinal products or concomitant
administration of COMIRNATY Omicron XBB.1.5 with other vaccines has
not been studied.
- Animal studies with COMIRNATY Original do not indicate direct
or indirect harmful effects with respect to reproductive
toxicity.
- The most frequent adverse reactions in infants 6 to 23 months
of age that received any primary course dose included irritability
(> 60%), drowsiness (> 40%), decreased appetite (> 30%),
tenderness at the injection site (> 20%), injection site redness
and fever (> 10%).
- The most frequent adverse reactions in children 2 to 4 years of
age that received any primary course dose included pain at
injection site and fatigue (> 40%), injection site redness and
fever (> 10%).
- The overall safety profile of COMIRNATY in participants 5 to 11
years of age was similar to that seen in participants 16 years of
age and older. The most frequent adverse reactions in children 5 to
11 years of age that received 2 doses were injection site pain
(> 80%), fatigue (> 50%), headache (> 30%), injection site
redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (>
10%).
- The overall safety profile for the booster dose was similar to
that seen after the primary course. The most frequent adverse
reactions in children 5 to 11 years of age were injection site pain
(> 60%), fatigue (> 30%), headache (> 20%), myalgia,
chills, injection site redness and swelling (> 10%)
- The overall safety profile of COMIRNATY in adolescents 12 to 15
years of age was similar to that seen in participants 16 years of
age and older. The most frequent adverse reactions in adolescents
12 to 15 years of age that received 2 doses were injection site
pain (> 90%), fatigue and headache (> 70%), myalgia and
chills (> 40%), arthralgia and pyrexia (> 20%).
- The most frequent adverse reactions in participants 16 years of
age and older that received 2 doses were injection site pain (>
80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%),
chills (> 30%), arthralgia (> 20%), pyrexia and injection
site swelling (> 10%) and were usually mild or moderate in
intensity and resolved within a few days after vaccination. A
slightly lower frequency of reactogenicity events was associated
with greater age.
- The safety profile for the booster dose (third dose) was
similar to that seen after 2 doses. The most frequent adverse
reactions in participants 18 to 55 years of age were injection site
pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia
(> 30%), chills and arthralgia (> 20%).
- The safety profile for the COMIRNATY Original/Omicron BA.4-5
booster (fourth dose) was similar to that seen after 3 doses. The
most frequent adverse reaction in participants 6 to 23 months of
age was irritability (> 20%), decreased appetite (> 10%), and
drowsiness (> 10%). The most frequent adverse reactions in
participants 2 to 4 years of age were injection site pain (>
30%) and fatigue (> 20%). The most frequent adverse reactions in
participants 5 to 11 years of age were injection site pain (>
60%), fatigue (> 40%), headache (> 20%), and muscle pain
(> 10%). The most frequent adverse reactions in participants 12
years of age and older were injection site pain (> 60%), fatigue
(> 50%), headache (> 40%), muscle pain (> 20%), chills
(> 10%), and joint pain (> 10%).
- The safety of COMIRNATY Omicron XBB.1.5 is inferred from safety
data of the prior COMIRNATY vaccines.
- The duration of protection afforded by the vaccine is unknown
as it is still being determined by ongoing clinical trials. As with
any vaccine, vaccination with COMIRNATY Omicron XBB.1.5 may not
protect all vaccine recipients.
- For complete information on the safety of COMIRNATY Omicron
XBB.1.5, always make reference to the approved Summary of Product
Characteristics and Package Leaflet available in all the languages
of the European Union on the EMA website.
The black equilateral triangle ▼ denotes that
additional monitoring is required to capture any adverse reactions.
This will allow quick identification of new safety information.
Individuals can help by reporting any side effects they may get.
Side effects can be reported to EudraVigilance or directly to
BioNTech using email medinfo@biontech.de, telephone +49 6131 9084
0, or via the website www.biontech.de
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
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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 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
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.
CONTACT
Pfizer: Media Relations+1 (212)
733-1226PfizerMediaRelations@pfizer.com
Investor Relations+1 (212)
733-4848IR@pfizer.com
BioNTech: Media RelationsJasmina
Alatovic+49 (0)6131 9084 1513Media@biontech.de
Investor RelationsVictoria Meissner, M.D.+1 617
528 8293Investors@biontech.de
---------- 1 World Health Organization (WHO)
Statement on the antigen composition of COVID-19 vaccines. 26 April
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. 30 April 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 European Medicines Agency (EMA) ETF recommends updating
COVID-19 vaccines to target new JN.1 variant. 30 April 2024.
Available at:
https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant
(Accessed 26.06.2024).
4 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).
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