- Expanded authorization allows more Americans to receive a
booster dose to help preserve a high-level of protection against
COVID-19
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced that the U.S. Food and Drug Administration (FDA) has
expanded the emergency use authorization (EUA) of a booster dose of
the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18
years of age and older. The booster dose is to be administered at
least six months after completion of the primary series, and is the
same dosage strength as the doses in the primary series.
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“As we near the two-year mark in our fight against COVID-19, we
have reached another critical milestone with the expanded
authorization of a booster dose of our COVID-19 vaccine in
individuals 18 years and older,” said Albert Bourla, Chairman and
Chief Executive Officer, Pfizer. “With boosters, more adults will
now have the opportunity to help preserve a high-level of
protection against this disease. We are grateful to the FDA for
their rigorous review, and the action taken today that we hope will
help accelerate our path out of this pandemic.”
“Today’s FDA decision is supported by clinical data showing
robust immune responses following a booster dose of our vaccine,
exceeding what has been seen even after the completion of the
highly-effective two-dose primary schedule,” said Ugur Sahin, M.D.,
CEO and Co-founder of BioNTech. “These data suggest a booster dose
of our vaccine has the potential to maintain a high-level of
protection against tested variants, including Delta.”
In October, the companies announced positive topline results
from the trial showing that a booster dose administered to
individuals who previously received the Pfizer-BioNTech primary
two-dose series demonstrated a relative vaccine efficacy of 95%
when compared to those who did not receive a booster. Thus far,
these are the first and only efficacy data disclosed from any
randomized, controlled COVID-19 vaccine booster trial. The adverse
event profile was generally consistent with other clinical safety
data for the vaccine, with no new safety concerns identified.
A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was
previously authorized by the FDA for emergency use after completion
of a primary series in individuals 65 years of age and older,
individuals 18 through 64 years of age at high risk of severe
COVID-19, and individuals 18 through 64 years of age with frequent
institutional or occupational exposure to SARS-CoV-2, as well as
eligible individuals who have completed primary vaccination with a
different authorized COVID-19 vaccine.
Pfizer and BioNTech continue to supply the vaccine, including
sufficient volume for boosters, under their existing supply
agreement with the U.S. government, which continues through April
2022. The companies do not expect that today’s news will impact the
existing supply agreements in place with governments and
international health organizations around the world.
About the Phase 3 COVID-19 Booster
Trial
The Phase 3 trial evaluated the efficacy and safety of a 30-µg
booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than
10,000 individuals 16 years of age and older in the U.S., Brazil,
and South Africa. All trial participants previously completed the
primary two-dose series of the Pfizer-BioNTech COVID-19 Vaccine,
and then were randomized 1:1 to receive either a 30-µg booster dose
(the same dosage strength as those in the primary series) or
placebo. The median time between second dose and administration of
the booster dose or placebo was approximately 11 months.
Symptomatic COVID-19 occurrence was measured from at least 7 days
after booster or placebo, with a median follow-up of 2.5 months.
Median age of participants was 53 years, with 55.5% of participants
between 16 and 55 years, and 23.3% of participants 65 years and
older. Multiple subgroup analyses showed efficacy was consistent
irrespective of age, sex, race, ethnicity, or comorbid
conditions.
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 other countries, 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.
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
18 years of age and older
- A single booster dose of the vaccine may be administered to
individuals 18 years of age and older who have completed primary
vaccination with a different authorized COVID-19 vaccine.
Individuals should check with their healthcare provider regarding
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 individuals 18 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is 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 of
age
- 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 individuals 18 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series
EUA Statement
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 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 Sheets 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 1 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, more commonly in 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. Individuals should seek medical attention right away
if they have any of the following symptoms after receiving the
vaccine:
- 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 older
Full Prescribing Information (16 years of age
and older) EUA Fact Sheet for Vaccination Providers (12 years of
age and older), Purple Cap EUA 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 age
EUA Fact Sheet for Vaccination Providers (5
through 11 years of age), Orange Cap Recipients and Caregivers Fact
Sheet (5 through 11 years of age)
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 November 18,
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 BNT162b2 mRNA vaccine
program, and the Pfizer BioNTech COVID-19 Vaccine, also known as
COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including emergency
use authorization of a booster dose for individuals 18 and older in
the U.S., 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 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 a potential booster dose, pediatric populations,
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 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) 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 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, 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 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 emergency
use authorization of a booster dose for individuals 18 and older in
the U.S., a definite submission of a supplemental BLA for a
potential booster dose of BNT162b2 in individuals 16 years of age
and older and/or a potential booster dose of a variation of
BNT162b2 having a modified mRNA sequence, a BLA to support
potential full FDA approval of BNT162b2 in individuals 12 through
15 years, 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 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; the ability of BioNTech to supply the
quantities of BNT162 to support clinical development and market
demand, including our production estimates for 2021; whether and
when additional supply agreements will be reached; challenges
related to public vaccine confidence or awareness; and
uncertainties regarding the impact of COVID-19 to 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, 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.
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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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