Follow-Up Data from Phase 3 Trial Of Pfizer-BioNTech COVID-19
Vaccine Support Safety and High Efficacy in Adolescents 12 Through
15 Years of Age
- 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
NEW YORK and MAINZ, GERMANY, November 22,
2021 — 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.
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 to 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 to 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 AgeThe updated analysis of the Phase 3 clinical trial in
individuals ages 12 to 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 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
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 olderFull 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 ageEUA 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’ 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 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 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 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.
CONTACTS
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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