NEW YORK and MAINZ, Germany, October 19, 2022 — Pfizer
Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced
that the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) has recommended marketing
authorization (MA) for a 3-µg dose of COMIRNATY® (COVID-19 vaccine,
mRNA), which is based on the wild-type spike protein of SARS-CoV-2,
as a three-dose series for children ages 6 months to less than 5
years (also referred to as 6 months through 4 years of age). The
European Commission will review the CHMP recommendation and is
expected to make a final decision soon.
Today’s recommendation is based on data from a
Phase 2/3 randomized, controlled trial that included 4,526 children
aged 6 months to less than 5 years. In the trial, children received
a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine
at least two months after the second dose at a time when Omicron
BA.2 was the predominant variant. Following the third dose in this
age group, the companies’ original COVID-19 vaccine was found to be
73.2% (2-sided 95% CI: 43.8%, 87.6%) effective at preventing
COVID-19, with a favorable safety profile similar to placebo. The
3-µg dose was carefully selected as the preferred dose for children
under 5 years of age based on safety, tolerability, and
immunogenicity.
The U.S. Food and Drug Administration (FDA)
granted emergency use authorization (EUA) of the original
Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in
this age group in June 2022. Submissions to other regulatory
agencies around the world are ongoing.
Pfizer and BioNTech are also in discussions with
health authorities regarding a regulatory pathway for potential
authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine for use in children under 5 years of age. A Phase 1/2/3
pediatric study was initiated in September 2022 to evaluate
different dosing regimens and dose levels of the Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.
COMIRNATY® and its adapted vaccine variations
(COMIRNATY® Original/Omicron BA.1 and COMIRNATY® Original/Omicron
BA.4-5) are based on BioNTech’s proprietary mRNA technology and
were developed by both BioNTech and Pfizer. BioNTech is the
Marketing Authorization Holder in the United States, the European
Union, the United Kingdom, Canada and the holder of emergency use
authorizations or equivalents in the United States (jointly with
Pfizer) and other countries. Submissions to pursue regulatory
approvals in those countries where emergency use authorizations or
equivalent were initially granted are planned.
About the Phase 1/2/3 Trial in Children for
the Original Pfizer-BioNTech COVID-19 Vaccine The Phase 1/2/3
trial (NCT04816643) has enrolled more than 10,000 children ages 6
months to under 12 years of age in the United States, Finland,
Poland, Spain and Brazil from more than 90 clinical trial sites.
The trial evaluated the safety, tolerability, and immunogenicity of
the original Pfizer-BioNTech COVID-19 Vaccine in three age groups:
ages 5 to less than12 years; ages 2 to less than 5 years; and ages
6 months to less than 2 years. Based on the Phase 1 dose-escalation
portion of the trial, children ages 5 to less than 12 years
received a two-dose schedule of 10 µg each while children under age
5 received three lower 3-µg doses in the Phase 2/3 study. The trial
enrolled children with or without prior evidence of SARS-CoV-2
infection.
AUTHORIZED USE IN THE
EU:COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 vaccine) has
been granted standard marketing authorization (MA) by the European
Commission to prevent coronavirus disease 2019 (COVID-19) in people
aged 5 years and older. The vaccine is administered as a 2-dose
series, 3 weeks apart. 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. In addition, the MA has been expanded
to include a booster dose (third dose) at least 3 months after the
second dose in individuals 12 years of age and older. A third
primary course dose may be administered at least 28 days after the
second dose to people aged 5 years and older with a severely
weakened immune system. 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 now available.In addition, COMIRNATY has also been
granted standard MA for two adapted vaccines: COMIRNATY
Original/Omicron BA.1, which contains mRNA encoding for the spike
protein of the wild-type and of the Omicron BA.1 subvariant of
SARS-CoV-2; and 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. COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may be
administered as a booster in people aged 12 years and older who
have received at least a primary vaccination course against
COVID-19. There should be an interval of at least 3 months between
administration of COMIRNATY Original/Omicron BA.1 or COMIRNATY
Original/Omicron BA.4-5 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 suggest that the course
of myocarditis and pericarditis following vaccination is not
different from myocarditis or pericarditis in general. The risk of
myocarditis after a booster dose of COMIRNATY, COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 has not
yet been characterized.
- Rare cases of acute peripheral facial paralysis; uncommon
incidence of insomnia, hyperhidrosis and night sweats; and unknown
incidence of paraesthesia, hypoaesthesia and erythema multiforme
have been identified in post-marketing experience.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation or stress‐related reactions (e. g.
dizziness, palpitations, increases in heart rate, alterations in
blood pressure, tingling sensations 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,
COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron
BA.4-5 may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY, COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not
protect all vaccine recipients. Individuals may not be fully
protected until 7 days after their second dose of the vaccine.
- Adverse reactions observed during clinical studies 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, tiredness, headache, muscle pain, chills, joint pain,
diarrhea, fever
- Common side effects: injection site redness, nausea,
vomiting
- Uncommon side effects: enlarged lymph nodes (more frequently
observed after the booster dose), feeling unwell, arm pain,
insomnia, injection site itching, allergic reactions such as rash
or 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, 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
- 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. COMIRNATY can be used
during pregnancy. No effects on the breast-fed newborn/infant are
anticipated since the systemic exposure of breast-feeding woman to
the initially approved COMIRNATY vaccine is negligible.
Observational data from women who were breast-feeding after
vaccination have not shown a risk for adverse effects in breast-fed
newborns/infants. COMIRNATY can be used during breast-feeding.
- No data are available yet regarding the use of COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during
pregnancy. Since differences between products are confined to the
spike protein sequence, and there are no clinically meaningful
differences in reactogenicity between those COMIRNATY
variant-adapted vaccines that have been clinically evaluated,
COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron
BA.4-5 can be used during pregnancy.
- No data are available yet regarding the use of COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 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 Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 can be used during
breast-feeding
- Interactions with other medicinal products or concomitant
administration of COMIRNATY, COMIRNATY Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 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 safety of a COMIRNATY Original/Omicron BA.1 booster dose in
individuals from 18 to ≤ 55 years of age is extrapolated from
safety data from a subset of 315 adults 18 to ≤ 55 years of age who
received a booster (fourth dose) of Omicron BA.1 30 µg (monovalent)
after completing 3 doses of COMIRNATY. The most frequent adverse
reactions in these participants 18 to ≤ 55 years of age were
injection site pain (> 70%), fatigue (> 60%), headache (>
40%), myalgia (> 30%), chills (> 30%) and arthralgia (>
20%).
- In a subset from the Phase 3 study, 305 adults > 55 years of
age who had completed 3 doses of COMIRNATY, received a booster of
COMIRNATY Original/Omicron BA.1 after receiving Dose 3. The overall
safety profile for the COMIRNATY Original/Omicron BA.1 booster
(fourth dose) was similar to that seen after the COMIRNATY booster
(third dose). The most frequent adverse reactions in participants
greater than 55 years of age were injection site pain (> 50%),
fatigue (> 40%), headache 69 (> 30%), myalgia (> 20%),
chills and arthralgia (> 10%). No new adverse reactions were
identified for COMIRNATY Original/Omicron BA.1.
- The safety of a booster dose of COMIRNATY Original/Omicron
BA.4-5 is inferred from safety data for a booster dose of COMIRNATY
Original/Omicron BA.1, as well as for a booster dose of COMIRNATY
Original.
- 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 Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine
recipients
- For complete information on the safety of COMIRNATY, COMIRNATY
Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5, 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 medinfo@biontech.de,
www.biontech.com or directly to BioNTech using email,
telephone +49 6131 9084 0, or via the website.
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 more than 170 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 and follow us on
Twitter 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 October 19, 2022. 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 a submission pending with the EMA and a CHMP
opinion for a 3-µg dose of COMIRNATY (COVID-19 vaccine, mRNA),
which is based on the wild-type spike protein of SARS-CoV-2, as a
three-dose series for children ages 6 months to less than 5 years
(also referred to as 6 months through 4 years of age, a regulatory
pathway for potential authorization of the companies’ Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine for use in children
under 5 years of age and a Phase 1/2/3 pediatric study of the
Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine, 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, bivalent or variant-adapted 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, bivalent or variant-adapted 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 and the submission pending
with the EMA for a 3-µg dose of COMIRNATY (COVID-19 vaccine, mRNA),
which is based on the wild-type spike protein of SARS-CoV-2, as a
three-dose series for children ages 6 months to less than 5 year),
any monovalent or bivalent vaccine candidates, 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 which may lead to
reduced revenues or excess inventory; risks related to the
availability of raw materials to manufacture 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 or next generation 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, 2021 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 is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company
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 T cells, bispecific
immune checkpoint modulators, targeted cancer antibodies and 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 pharmaceutical collaborators, including
Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-looking StatementsThis
press release contains “forward-looking statements” of BioNTech
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to, statements concerning: BioNTech’s efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer including
the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19
vaccine, mRNA) (BNT162b2) (including the potential in children 6
months to 5 years of age and a positive CHMP opinion on the
administration in children 6 months to 5 years of age in the EU,
clinical trials studying the use BNT162b2 and its adapted vaccine
variations in children 6 months to 12 years of age, an EUA in the
U.S. and a submission pending with the EMA for an Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 to
less than 12 years of age, qualitative assessments of available
data, potential benefits, expectations for clinical trials, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply); our expectations regarding the potential characteristics
of BNT162b2 in our clinical trials, real world data studies, and/or
in commercial use based on data observations to date; preclinical
and clinical data (including Phase 1/2/3 or Phase 4 data),
including the descriptive data discussed in this release, for
BNT162b2 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, including the risk that final
or formal results from the clinical trial could differ from the
topline data; the ability of BNT162b2 or a future vaccine to
prevent COVID-19 caused by emerging virus variants; the expected
time point for additional readouts on efficacy data of BNT162b2 and
its adapted vaccine variations in our clinical trials; the nature
of the clinical data, which is subject to ongoing peer review,
regulatory review and market interpretation; widespread use of
BNT162b2 and its adapted vaccine variations 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 timing for submission of data for BNT162, or
any future vaccine, in additional populations, (including in
children 6 months to less than 5 years of age, potential future
annual boosters or re-vaccinations), or receipt of, any marketing
approval or emergency use authorization or equivalent, including or
amendments or variations to such authorizations, 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; the
development of other vaccine formulations, booster doses or
potential future annual boosters or re-vaccinations or new variant
based vaccines; our contemplated shipping and storage plan,
including our estimated product shelf life at various temperatures;
the ability of BioNTech to supply the quantities of BNT162 and its
adapted vaccine variations to support clinical development and
market demand, including our production estimates for 2022;
challenges related to public vaccine confidence or awareness;
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 which may lead to reduced revenues or excess
inventory; the availability of raw material to manufacture BNT162
or other vaccine formulation; 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; and uncertainties regarding the impact
of COVID-19 on BioNTech’s trials, business and general operations.
Any forward-looking statements in this press release are based on
BioNTech current expectations and beliefs of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: the ability to
meet the pre-defined endpoints in clinical trials; competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical or other results, including our stated rate of vaccine
effectiveness and safety and tolerability profile observed to date,
in the remainder of the trial or in larger, more diverse
populations upon commercialization; the ability to effectively
scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the
quarter ended June 30, 2022, filed with the SEC on August 8, 2022,
which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
CONTACTS
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 Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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