Pfizer and BioNTech Receive First U.S. FDA Emergency Use
Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11
Years
- Emergency Use Authorization (EUA) is supported by clinical data
showing a favorable safety profile and high vaccine efficacy of
90.7% in children 5 through 11 years of age during
a period when Delta was the prevalent strain
- With this authorization, the Pfizer-BioNTech COVID-19 Vaccine
is currently the only COVID-19 vaccine available in the U.S. for
use in this age group
- FDA action represents an important milestone with the potential
to help protect millions of school-aged children from COVID-19
infection
NEW YORK and MAINZ, GERMANY, OCTOBER 29,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced that the U.S. Food and Drug Administration
(FDA) has authorized for emergency use the Pfizer-BioNTech COVID-19
Vaccine for children 5 through 11 years of age (also referred to as
5 to <12 years). For this age group, the vaccine is to be
administered in a two-dose regimen of 10-µg doses given 21 days
apart. The 10-µg dose level was carefully selected based on safety,
tolerability and immunogenicity data. This is the first COVID-19
vaccine authorized in the U.S. for individuals 5 through 11 years
of age.
“This is a day so many parents, eager to protect
their young children from this virus, have been waiting for,” said
Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “Over 6 million children in the U.S. have been
diagnosed with COVID-19 since the start of this pandemic, and a
high number of young people continue to be infected every week.
With this FDA authorization, we have achieved another key marker in
our ongoing effort to help protect families and communities, and to
get this disease under control.”
“Today’s emergency use authorization is
supported by clinical data showing a favorable safety profile
and high vaccine efficacy in children, underlining its potential to
address a current public health need,” said Ugur Sahin,
M.D., CEO and Co-founder of BioNTech. “As children 5
through 11 get reacclimated to the new school year, both in and out
of the classroom, our goal is to help keep them safe and protected
and get them back to normalcy.”
The FDA based its decision on data from a Phase
2/3 randomized, controlled trial that included ~4,500 children 5
through 11 years of age (2,268 from the original group and 2,379
from the supplemental safety group). Results from this trial were
reviewed by the FDA Vaccines and Related Biological Products
Advisory Committee (VRBPAC). In the trial, the vaccine demonstrated
a favorable safety profile, robust immune responses and a vaccine
efficacy rate of 90.7% in participants without prior SARS-CoV-2
infection, measured from 7 days after the second dose. The Data
Monitoring Committee for the study has reviewed the data and has
not identified any serious safety concerns related to the
vaccine.
The companies will begin shipping 10-µg
pediatric doses immediately, as directed by the U.S. government
(ages referred to as 5y to <12y on the vial and 5 to <12
years on the carton). 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.
As a next step, the U.S. Centers for Disease
Control and Prevention’s (CDC) Advisory Committee on Immunization
Practices (ACIP) will meet next week to discuss a potential
recommendation for the use and rollout of the vaccine to children 5
through 11 years of age. Pediatric vaccinations are anticipated to
start, subject to, and after, CDC endorses the ACIP
recommendation.
Pfizer and BioNTech have submitted requests for
authorization of their COVID-19 vaccine in this age group to other
regulators around the world, including the European Medicines
Agency. Initial data from the other two age cohorts in the ongoing
Pfizer-BioNTech clinical trial in children – those 2 to <5 years
of age and those 6 months to <2 years of age – are expected as
soon as fourth quarter 2021 or early first quarter 2022.
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 or ongoing.
U.S. INDICATION & AUTHORIZED
USE
HOW IS THE VACCINE GIVEN?The vaccine will be
given as an injection into the muscle.
Primary Series: In individuals 5 years of age
and older, the vaccine is administered as a 2-dose series, 3 weeks
apart. In individuals 12 years of age and older, a third primary
series dose may be administered at least 4 weeks after the second
dose to individuals who are determined to have certain kinds of
immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at
least 6 months after completion of a primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- A single booster dose of the vaccine may be administered to
certain individuals who have completed primary vaccination with a
different authorized COVID-19 vaccine. Individuals should check
with their healthcare provider regarding eligibility for, and
timing of, the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has
received EUA from FDA to provide:
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to the following individuals who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY®:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have
completed primary vaccination with a different authorized COVID-19
vaccine. Booster eligibility and schedule are based on the labeling
information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an
FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in
individuals 16 years of age and older
- It is also authorized under EUA to provide:
- a 2-dose primary series to individuals 12 through 15 years
- a third primary series dose to individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to the following individuals who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY®:
-
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have
completed primary vaccination with a different authorized COVID-19
vaccine. Booster eligibility and schedule are based on the labeling
information of the vaccine used for the primary series
EUA StatementEmergency 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 5
years of age and older. 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. Please
see EUA Fact Sheet at www.cvdvaccine-us.com
IMPORTANT SAFETY
INFORMATION
Individuals should not get the
vaccine if they:
- had a severe allergic reaction after a previous dose of this
vaccine
- had a severe allergic reaction to any ingredient of this
vaccine
Individuals should tell the vaccination provider
about all of their medical conditions, including if they:
- 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
The vaccine may not protect everyone.Side
effects reported with the vaccine include:
- There is a remote chance that the vaccine could cause a severe
allergic reaction
- A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the vaccine. For this
reason, vaccination providers may ask individuals to stay at the
place where they received the vaccine for monitoring after
vaccination
- Signs of a severe allergic reaction can include difficulty
breathing, swelling of the face and throat, a fast heartbeat, a bad
rash all over the body, dizziness, and weakness
- If an individual experiences a severe allergic reaction, they
should call 9-1-1 or go to the nearest hospital
- 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. 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.
Individuals should seek medical attention right away if they 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
- Additional side effects that have been reported with the
vaccine include:
- severe allergic reactions; non-severe allergic reactions such
as rash, itching, hives, or swelling of the face; myocarditis
(inflammation of the heart muscle); pericarditis (inflammation of
the lining outside the heart); injection site pain; tiredness;
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
- These may not be all the possible side effects of the vaccine.
Serious and unexpected side effects may occur. The possible side
effects of the vaccine are still being studied in clinical trials.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the
same time as other vaccines have not yet been submitted to FDA.
Individuals considering receiving this vaccine with other vaccines,
should discuss their options with their healthcare provider.
Patients should always ask their healthcare
providers for medical advice about adverse events. Individuals are
encouraged to report negative side effects of vaccines to the US
Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or
call 1‐800‐ 822‐7967. In addition, side effects can be reported to
Pfizer Inc. at www.pfizersafetyreporting.com or by calling
1-800-438-1985.
Click for Fact Sheets and Prescribing
Information for individuals 12 years of age and olderFull
Prescribing Information (16 years of age and
older)EUA Fact Sheet for Vaccination Providers (12
years of age and older), Purple CapEUA Fact Sheet
for Vaccination Providers (12 years of age and older), Gray
Cap Recipients and Caregivers Fact Sheet (12 years
of age and older)Fact Sheets for individuals 5 through 11
years of ageEUA Fact Sheet for Vaccination Providers (5
through 11 years of age), Orange CapRecipients and
Caregivers Fact Sheet (5 through 11 years of age)
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 October 29, 2021.
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 BNT162 mRNA vaccine program and COMIRNATY (COVID-19
Vaccine, mRNA) (BNT162b2) (including the potential in children 5
through 11 years of age (also referred to as 5 to <12 years) and
emergency use authorization in the U.S., a study in children 6
months to 5 years of age, qualitative assessments of available
data, potential benefits, expectations for clinical trials, 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 the Phase
2/3 data), 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 or in larger, more diverse populations following
commercialization; the ability of BNT162b2 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 for ages <5 years, applications for
ages 5 through 11 years or a potential booster dose 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, and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including potential submissions for younger
pediatric populations, a potential booster dose or any other
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;
risks related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, two-dose
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
new variant-specific vaccines; the risk that we may not be able to
create 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, 2020 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, Bayer Animal Health, 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 qualitative assessments of available data,
potential benefits, expectations for clinical trials, the potential
of BNT162b2 for children 5 through 11 years of age (also referred
to as 5 to <12 years), evaluation of BNT162b2 in children 6
months to <5 years old, 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
and/or in commercial use based on data observations to date; the
ability of BNT162b2 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; the timing for submission of data
for, or receipt of, any marketing approval or Emergency Use
Authorization; our contemplated shipping and storage plan,
including our estimated product shelf life at various temperatures;
and the ability of BioNTech to supply the quantities of BNT162 to
support clinical development and market demand, including our
production estimates for 2021. 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, 2020, filed with the SEC on March 30, 2021,
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)
733-1226PfizerMediaRelations@pfizer.com
Investor Relations+1 (212)
733-4848IR@pfizer.com
BioNTech: Media
RelationsJasmina Alatovic+49 (0)6131 9084 1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D. +49
(0)6131 9084 1074Investors@biontech.de
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