- In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19
Vaccine elicited a strong immune response in this age group
- Three 3-µg doses had favorable safety profile similar to
placebo in young children ages 6 months through 4 years in Phase
2/3 clinical trial
- Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for
all individuals 6 months of age and older
NEW YORK and MAINZ, GERMANY, June 17,
2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
today announced the U.S. Food and Drug Administration (FDA) granted
emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19
Vaccine as a three 3-µg dose series for children 6 months through 4
years of age (also referred to as 6 months to less than 5 years of
age). The 3-µg dose was carefully selected as the preferred dose
for children under 5 years of age based on safety, tolerability,
and immunogenicity data.
“Tens of millions of older children across the
globe have already been vaccinated with our COVID-19 vaccine,
helping to prevent symptomatic, severe disease and hospitalization.
We know many parents in the U.S. have been eagerly awaiting an
authorized vaccine for their children under 5 and we are proud to
now offer them a vaccine option with a favorable safety profile,”
said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “We are grateful to all the parents and caregivers who
made today’s authorization possible by choosing to enroll their
children in our COVID-19 vaccine clinical trial.”
“We are committed to providing access to our
COVID-19 vaccine to all age groups. Parents in the U.S. now have
the option to vaccinate their children under 5 years of age, and we
are working to ensure that other countries worldwide will follow,”
said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“The data from our Phase 2/3 study show that a dose level of 3-µg
of our vaccine, which we selected based on safety,
tolerability and immunogenicity data, administered in a 3-dose
series, provides young children and infants with a high level of
protection, also during the recent Omicron wave.”
The EUA is based on data from a Phase 2/3
randomized, controlled trial that included 4,526 children 6 months
through 4 years of age. In the trial, children received the third
3-µg dose at least two months after the second dose at a time when
Omicron was the predominant variant. Following a third dose in this
age group, the vaccine was found to elicit a strong immune
response, with a favorable safety profile similar to placebo.
In the trial, the SARS-CoV-2-neutralizing
antibody geometric mean titer (GMT) one month after the third dose
was 1,535.2 (95% CI, 1,388.2, 1,697.8) in children 2 through 4
years of age and 1,406.5 (95% CI, 1,211.3, 1,633.1) in infants 6
through 23 months. The antibody responses in both age groups were
comparable to those recorded in people 16 to 25 years of age
immunized with two 30-µg doses and met the pre-specified success
criteria to declare non-inferiority. Demonstration of
noninferiority and safety were the regulatory requirements for
potential authorization of the Pfizer-BioNTech COVID-19 Vaccine in
this age group.
Three 3-µg doses of the Pfizer-BioNTech COVID-19
Vaccine demonstrated a favorable safety and tolerability profile
comparable to placebo. No new safety signals were identified, and
the frequency of adverse reactions observed in children 6 months
through 4 years were generally lower than in children 5 through 11
years. In the 6 through 23 months age group, 30.3% participants
reported adverse events in the Pfizer-BioNTech COVID-19 Vaccine
group, and 27.3% participants reported adverse events in the
placebo group. Similarly, in the 2 through 4-year age group, the
Pfizer-BioNTech COVID-19 Vaccine and placebo participants reported
18.8% and 18.9% respectively. Reactogenicity events were mostly
mild to moderate and short lived for both age groups with systemic
events comparable to placebo. Reactions were comparable after dose
1, 2 and 3.
The clinical trial results were reviewed by the
FDA Vaccines and Related Biological Products Advisory Committee
(VRBPAC) on June 15, who unanimously recommended authorization. The
U.S. Centers for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practices (ACIP) will meet June 17 and
June 18 to discuss a potential recommendation for the use and
rollout of the vaccine to children 6 months through 4 years of age.
Vaccinations for children 6 months through 4 years of age are
anticipated to start subject to and after the CDC endorses the ACIP
recommendation.
Pfizer and BioNTech will begin shipping 3-µg
pediatric doses as directed by the U.S. government. Eligible U.S.
residents will continue to receive the vaccine for free, consistent
with the U.S. government’s commitment to free access to COVID-19
vaccines.
The companies plan to submit requests for
authorization of their COVID-19 vaccine in this age group to other
regulators around the world, including the European Medicines
Agency in early July.
The Pfizer-BioNTech COVID-19 Vaccine, which is
based on BioNTech’s proprietary mRNA technology, was 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
ChildrenThe Phase 1/2/3 trial 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 Pfizer-BioNTech COVID-19 Vaccine in three
age groups: ages 5 to under 12 years; ages 2 to under 5 years; and
ages 6 months to under 2 years. Based on the Phase 1
dose-escalation portion of the trial, children ages 5 to under 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.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under
Emergency Use Authorization (EUA) for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6
months of age and older. Pfizer-BioNTech COVID-19 Vaccine is
FDA authorized to provide:
Primary Series
-
A 3-dose primary series to individuals 6 months through 4 years of
age
-
a 2-dose primary series to individuals 5 years of age and
older
-
a third primary series dose to individuals 5 years of age and older
with certain kinds of immunocompromise
Booster Series
-
a single booster dose to individuals 5 through 11 years of age who
have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine
-
a first booster dose to individuals 12 years of age and older who
have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
(COVID-19 Vaccine, mRNA)
-
a first booster dose to individuals 18 years of age and older who
have completed primary vaccination with a different
authorized or approved COVID-19 vaccine. The booster
schedule is based on the labeling information of the vaccine used
for the primary series
-
a second booster dose to individuals 50 years of age and older who
have received a first booster dose of any authorized or approved
COVID-19 vaccine
-
a second booster dose to individuals 12 years of age and older with
certain kinds of immunocompromise and who have received a first
booster dose of any authorized or approved COVID-19 vaccine
COMIRNATY® INDICATIONCOMIRNATY® (COVID-19
Vaccine, mRNA) is a vaccine approved for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16
years of age and older.
- COMIRNATY® is administered as a 2-dose primary
series
COMIRNATY® AUTHORIZED USESCOMIRNATY® (COVID-19
Vaccine, mRNA) is FDA authorized under Emergency Use Authorization
(EUA) to provide:
Primary Series
- a 2-dose primary series to individuals 12 through 15 years of
age
- a third primary series dose to individuals 12 years of age and
older with certain kinds of immunocompromise
Booster Dose
- a first booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- a first booster dose to individuals 18 years of age and older
who have completed primary vaccination with another authorized or
approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
- a second booster dose to individuals 50 years of age and older
who have received a first booster dose of any authorized or
approved COVID-19 vaccine
- a second booster dose to individuals 12 years of age and older
with certain kinds of immunocompromise and who have received a
first booster dose of any authorized or approved COVID-19
vaccine
Emergency Use AuthorizationEmergency uses of the vaccine
have not been approved or licensed by FDA, but have been authorized
by FDA, under an Emergency Use Authorization (EUA) to prevent
Coronavirus Disease 2019 (COVID 19) in individuals 12 years of age
and older, in individuals 5 through 11 years of age, or in
individuals 6 months through 4 years of age, as appropriate. The
emergency uses are only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of the medical product under Section 564(b)(1) of
the FD&C Act unless the declaration is terminated or
authorization revoked sooner.
INTERCHANGEABILITYFDA-approved COMIRNATY® (COVID-19
Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA
authorized for Emergency Use Authorization (EUA) for individuals 12
years of age and older can be used interchangeably by a vaccination
provider when prepared according to their respective instructions
for use.
The formulation of the Pfizer-BioNTech COVID-19
Vaccine authorized for use in children 6 months through 4 years of
age and children 5 through 11 years of age differs from the
formulations authorized for individuals 12 years of age and older
and should therefore not be used interchangeably. The
Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6
months through 4 years of age and children 5 through 11 years of
age should not be used interchangeably with COMIRNATY® (COVID-19
Vaccine, mRNA).
IMPORTANT SAFETY INFORMATION
Tell your vaccination provider about all of your or your
child’s medical conditions, including if you or your child:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19
Vaccine, mRNA) may not protect all vaccine recipients
- You or your child should not receive Pfizer-BioNTech
COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if
you have had a severe allergic reaction to any of its ingredients
or had a severe allergic reaction to a previous dose of
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
- There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine
or COMIRNATY® (COVID-19 Vaccine, mRNA) could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to 1 hour after getting a dose of the vaccine.
For this reason, your vaccination provider may ask you or your
child to stay at the place where the vaccine was administered for
monitoring after vaccination. If you or your child experience a
severe allergic reaction, call 9-1-1 or go to the nearest
hospital
Seek medical attention right away if you or your child have
any of the following symptoms:
- difficulty breathing, swelling of the face and throat, a fast
heartbeat, a bad rash all over the body, dizziness, and
weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine, more commonly in
adolescent males and adult males under 40 years of age than among
females and older males. In most of these people, symptoms began
within a few days following receipt of the second dose of the
vaccine. The chance of having this occur is very low
Seek medical attention right away if you or your child have
any of the following symptoms after receiving the vaccine:
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding
heart
- fainting
- unusual and persistent irritability
- unusual and persistent poor feeding
- unusual and persistent fatigue or lack of energy
- persistent vomiting
- persistent pain in the abdomen
- unusual and persistent cool, pale skin
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
(COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and
hurt themselves. For this reason, your vaccination provider may ask
you or your child to sit or lie down for 15 minutes after receiving
the vaccine
- Some people with weakened immune systems may have reduced
immune responses to Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY® (COVID-19 Vaccine, mRNA)
- Additional side effects include rash, itching, hives, swelling
of the face, injection site pain, tiredness, feeling weak or lack
of energy, headache, muscle pain, chills, joint pain, fever,
injection site swelling, injection site redness, nausea, feeling
unwell, swollen lymph nodes (lymphadenopathy), decreased appetite,
diarrhea, vomiting, arm pain, fainting in association with
injection of the vaccine, and irritability
These may not be all the possible side effects of the vaccine.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away.
- You should always
ask your healthcare providers for medical advice about adverse
events. Report vaccine side effects to the US Food and Drug
Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll-free number is 1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. You can also report side
effects to Pfizer Inc. at www.pfizersafetyreporting.com or by
calling 1-800-438-1985
Click for Fact Sheets and Prescribing Information for
individuals 6 months of age and older:
Recipients and Caregivers Fact Sheet (6 months
through 4 years of age)Recipients and Caregivers Fact Sheet (5
through 11 years of age)Recipients and Caregivers Fact Sheet (12
years of age and older)COMIRNATY® Full Prescribing Information (16
years of age and older), DILUTE BEFORE USE, Purple
CapCOMIRNATY® Full Prescribing Information (16 years of age and
older), DO NOT DILUTE, Gray CapEUA Fact Sheet for Vaccination
Providers (6 months through 4 years of age), DILUTE BEFORE USE,
Maroon CapEUA Fact Sheet for Vaccination Providers (5 through 11
years of age), DILUTE BEFORE USE, Orange CapEUA Fact Sheet for
Vaccination Providers (12 years of age and older), DILUTE
BEFORE USE, Purple CapEUA Fact Sheet for Vaccination Providers
(12 years of age and older), DO NOT DILUTE, Gray Cap
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 www.Pfizer.com and follow us on Twitter
at @Pfizer and @Pfizer
News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe information
contained in this release is as of June 17, 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 emergency use authorization in the U.S. to
include children 6 months through 4 years of age (also referred to
as 6 months to under 5 years of age) and 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 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, including the risk
that final results from the Phase 2/3 trial, including the planned
formal vaccine efficacy analysis, could differ significantly from
the data currently publicly available or included in this release;
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 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 or any potential future
vaccines (including potential submissions in particular
jurisdictions for children 6 months through 4 years of age and
potential future annual boosters or re-vaccinations) 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 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 potential submissions in particular
jurisdictions for children 6 months through 4 years of age and any
requested amendments to the emergency use or conditional marketing
authorizations) 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 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,
bi-specific checkpoint immuno-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.de.
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 emergency use
authorization in the U.S. to include children 6 months to under 5
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 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 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 under 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 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 Annual Report as Form 20-F for the
Year Ended December 31, 2021, filed with the SEC on March 30, 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) 733-7410
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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