- First emergency use authorization in the United States for a
COVID-19 vaccine booster in adolescents 12 through 15 years of
age
- Today’s FDA action also reduces time between completion of
primary series and booster dose for all eligible individuals, and
authorizes a third primary series dose for individuals 5 through 11
years of age with certain kinds of immunocompromise
- Pfizer and BioNTech fulfill their goal to deliver 1 billion
doses of their COVID-19 vaccine to low- and middle-income countries
in 2021
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 12
years of age and older. The booster dose is the same dosage
strength (30-µg) as the dose approved in the primary series.
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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 16 years of age and older. The
vaccine is also authorized for eligible individuals 18 and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine.
“The recent rise in COVID-19 cases is concerning to all and
today’s decision by the FDA to further expand the Emergency Use
Authorization of a booster dose of our vaccine is critical to help
us ultimately defeat this pandemic,” said Albert Bourla, Chairman
and Chief Executive Officer, Pfizer. “We continue to believe that
broad use of boosters is essential to preserving a high level of
protection against this disease and reducing the rate of
hospitalizations.”
“The booster vaccination increases the level of immunity and
improves protection against COVID-19 across all age groups that
have been authorized to receive one,” said Ugur Sahin, M.D., CEO
and Co-founder of BioNTech. “In the current situation, it is
important to offer all eligible individuals a booster, particularly
against the backdrop of the newly-emerging variants such as
Omicron.”
Real world evidence from the Ministry of Health of Israel on the
administration of over 4.1 million third doses of the
Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the
primary series revealed no new safety concerns in adolescents 12
through 17 years of age.1
Additional EUA
Amendments
Separately, the FDA is also amending the existing EUA to reduce
the time for administration of a booster dose from at least six
months to at least five months following completion of the primary
series for individuals 12 years of age and older. The reduction of
time between the primary series is supported by real world evidence
from the Ministry of Health of Israel on the administration of
third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least
5 months after the primary series, which revealed no new safety
concerns in adults.1
Finally, the FDA has expanded the current Emergency Use
Authorization to include administration of a third primary series
dose at least 28 days following the second dose for individuals 5
through 11 years of age who have who have been determined to have
certain kinds of immunocompromise. This authorization is based on
information extrapolated from an independent report evaluating
safety and effectiveness of a third dose in adults who received
solid organ transplants. A third primary dose of the
Pfizer-BioNTech vaccine was previously authorized for
administration to individuals at least 12 years of age who have
been determined to have certain kinds of immunocompromise.
The companies continue to supply the vaccine, including booster
doses, 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. As of December 29, 2021, Pfizer and
BioNTech have delivered 1 billion doses of the Pfizer-BioNTech
COVID-19 Vaccine to low- and middle-income countries. The companies
expect to deliver an additional 1 billion doses to these nations in
2022. These doses are part of Pfizer and BioNTech’s previously
announced pledge to provide 2 billion doses of the COVID-19 vaccine
to low- and middle-income countries between 2021 and 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 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 5
years of age and older, a third primary series dose may be
administered at least 28 days 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 5 months after completion of a primary series of the
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine,
mRNA) to individuals 12 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 5 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single 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 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 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 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:
- 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 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 January 3,
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 12 years and
older in the U.S., reduction of time between completion of primary
series and booster dose, authorization of a third primary series
does authorized for individuals 5 through 11 years old with certain
kinds of immunocompromise, qualitative assessments of available
data, potential benefits, expectations for clinical trials, supply
agreements with the U.S. government, as well as governments and
international health organizations around the world, and the timing
of delivery of doses thereunder, 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, including a
potential variant-specific vaccine, and if obtained, whether or
when such emergency use authorizations or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including any requested amendments to the
emergency use or conditional marketing authorizations) 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, 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 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: a planned submission of a supplemental BLA for a potential
booster dose of BNT162b2 in individuals 16 years of age and older,
a supplemental 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 risk of further widespread
use of our 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; decisions by
regulatory authorities that may impact labeling or marketing,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of our vaccine,
including development of products or therapies by other companies;
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; disruptions in the relationships between us
and our collaboration partners, clinical trial sites or other
third-parties; 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 BioNTech and third-party providers;
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.
______________________
1 Ministry of Health of Israel. Division of Epidemiology.
(December 15, 2021). Corona Vaccine Safety [PowerPoint
presentation]. Vaccine Efficacy & Safety Follow-up Committee,
Israel.
https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_vaccine-safty-15122021.pdf
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Pfizer: Media Relations +1 (212) 733-7410
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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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