- Upon authorization by the European
Commission, 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 in July 2024
- Doses will be ready to ship to
applicable European Union member states as soon as possible upon
European Commission authorization
NEW YORK and MAINZ, GERMANY, SEPTEMBER
20, 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 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 (“EC”) 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.
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.
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 individuals 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.
COMIRNATYJN.1 contains mRNA encoding for the
spike protein of the JN.1 subvariant of SARS-CoV-2.
COMIRNATY JN.1may 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
JN.1 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 dizziness;
common incidence of vomiting, very common diarrhoea and unknown
incidence (cannot be estimated from available data) of,
paraesthesia, hypoaesthesia and erythema multiforme, extensive
swelling of vaccinated limb, facial swelling (in vaccine recipients
with a history of injection of dermatological fillers) 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
JN.1may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY JN.1 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.
- Overdose data is available from 52 study participants included
in the clinical trial that due to an error in dilution received 58
micrograms of COMIRNATY. The vaccine recipients did not report an
increase in reactogenicity or adverse reactions. In the event of
overdose, monitoring of vital functions and possible symptomatic
treatment is recommended.
- 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 JN.1during pregnancy. Based on
data available with other vaccine variants, COMIRNATY JN.1can be
used during pregnancy.
- No data are available yet regarding the use of COMIRNATY
JN.1during 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 JN.1can be used during
breast-feeding.
- Interactions with other medicinal products or concomitant
administration of COMIRNATY JN.1with other vaccines has not been
studied in 3 mcg and 10 mcg dose. For 30 mcg dose, COMIRNATY
JN.1may be administered concomitantly with seasonal influenza
vaccine. Different injectable vaccines should be given at different
injection sites.
- 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 JN.1 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 JN.1may not protect all
vaccine recipients.
- For complete information on the safety of COMIRNATY JN.1,
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
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 20, 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 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 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.
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
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.
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