- Pfizer-BioNTech vaccine demonstrated 100% efficacy against
COVID-19 in longer-term analysis, with no serious safety concerns
identified
- Data will support planned submissions for full regulatory
approval of the vaccine in this age group in the U.S. and
worldwide
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) today
announced topline results from a longer-term analysis of the safety
and efficacy of their COVID-19 vaccine in individuals 12 through 15
years of age. The updated findings from the companies’ pivotal
Phase 3 trial show that a two-dose series of the Pfizer-BioNTech
COVID-19 Vaccine (30-µg per dose) was 100% effective against
COVID-19, measured seven days through over four months after the
second dose.
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The adverse event profile was generally consistent with other
clinical safety data for the vaccine, with no serious safety
concerns observed in individuals with at least 6 months of safety
follow-up after the second dose.
“As the global health community works to increase the number of
vaccinated people around the world, these additional data provide
further confidence in our vaccine’s safety and effectiveness
profile in adolescents. This is especially important as we see
rates of COVID-19 climbing in this age group in some regions, while
vaccine uptake has slowed,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “We look forward to sharing these data
with the FDA and other regulators.”
“These are the first and only disclosed longer-term data
demonstrating the safety and efficacy of a COVID-19 vaccine in
individuals 12 through 15 years of age,” said Ugur Sahin, CEO and
Co-founder of BioNTech. “The growing body of data we have compiled
from clinical trials and real-world surveillance to date strengthen
the base of evidence supporting the strong efficacy and favorable
safety profile of our COVID-19 vaccine across adolescent and adult
populations.”
These longer-term follow-up data will form the basis for a
planned supplemental Biologics License Application (sBLA) to be
submitted to the FDA to expand approval of the vaccine for use in
individuals 12 years and older. The vaccine is currently available
for individuals 12 through 15 years of age under Emergency Use
Authorization (EUA), granted by the FDA in May 2021. The companies
also plan to submit these data to pursue regulatory approvals for
this age group in other countries where emergency use
authorizations or equivalents were initially granted.
About the Analysis in Adolescents 12-15 Years of Age The
updated analysis of the Phase 3 clinical trial in individuals ages
12 through 15 years was conducted in accordance with guidance from
the FDA for all companies investigating COVID-19 vaccines to review
safety and efficacy at key milestones. Data through up to six
months after the primary vaccination series are required for
licensure. These data were collected from November 2020 to
September 2021.
Results from this analysis of 2,228 trial participants build
upon and confirm previously released data and demonstrate strong
protection against COVID-19. From the 30 confirmed symptomatic
cases of COVID-19 in the trial with and without evidence of prior
infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo
group and 0 cases were in the Pfizer-BioNTech vaccine group,
corresponding to vaccine efficacy of 100% (95% confidence interval
[CI, 87.5, 100.0]).
Efficacy was consistently high across gender, race and ethnicity
demographics, obesity and comorbidity status. Pfizer and BioNTech
plan to submit these data for scientific peer review for potential
publication.
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:
- 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 November 22, 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 planned
sBLA and other submissions to expand approval of the vaccine for
use in individuals 12 years and older, 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 the potential
sBLA and other submissions to expand approval of the vaccine for
use in individuals 12 years and older will be submitted and 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
the potential sBLA and other submissions to expand approval of the
vaccine for use in individuals 12 years and older 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;
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 the planned sBLA submission
and other submissions globally to request approval of BNT162b2 in
individuals 12 years of age and older, 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; challenges related to public vaccine
confidence or awareness; 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, 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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