- 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
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.
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“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% of participants
reported adverse events in the Pfizer-BioNTech COVID-19 Vaccine
group, and 27.3% of participants reported adverse events in the
placebo group. Similarly, 18.8% and 18.9% of participants who
received the Pfizer-BioNTech COVID-19 Vaccine or placebo
respectively reported adverse events in the 2 through 4-year age
group.
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
Children
The 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® INDICATION
COMIRNATY® (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 USES
COMIRNATY® (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
Authorization
Emergency 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.
INTERCHANGEABILITY
FDA-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 Cap COMIRNATY® Full Prescribing
Information (16 years of age and older), DO NOT DILUTE, Gray
Cap EUA Fact Sheet for Vaccination Providers (6 months
through 4 years of age), DILUTE BEFORE USE, Maroon Cap EUA
Fact Sheet for Vaccination Providers (5 through 11 years of age),
DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination
Providers (12 years of age and older), DILUTE BEFORE USE, Purple
Cap EUA Fact Sheet for Vaccination Providers (12 years of
age and older), DO NOT DILUTE, Gray Cap
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world’s premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
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 Notice
The 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 BioNTech
Biopharmaceutical 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 Statements
This 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.
View source
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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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