Pfizer and BioNTech Announce Phase 3 Trial Data Showing High
Efficacy of a Booster Dose of Their COVID-19 Vaccine
- First results from any randomized, controlled COVID-19 vaccine
booster trial demonstrate a relative vaccine efficacy of 95.6%
against disease during a period when Delta was the prevalent
strain
- In trial with more than 10,000 participants 16 years of age and
older, COVID-19 booster was found to have a favorable safety
profile
- Companies plan to submit these data to FDA, EMA and other
regulatory agencies to further support licensure in the U.S. and
other countries
NEW YORK and MAINZ, GERMANY, October 21,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
today announced topline results from a Phase 3 randomized,
controlled trial evaluating 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 trial, a
booster dose administered to individuals who previously received
the Pfizer-BioNTech primary two-dose series restored vaccine
protection against COVID-19 to the high levels achieved after the
second dose, showing a relative vaccine efficacy of 95.6% when
compared to those who did not receive a booster. These are the
first efficacy results from any randomized, controlled COVID-19
vaccine booster trial.
“These results provide further evidence of the
benefits of boosters as we aim to keep people well-protected
against this disease,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “In addition to our efforts to
increase global access and uptake among the unvaccinated, we
believe boosters have a critical role to play in addressing the
ongoing public health threat of this pandemic. We look forward to
sharing these data with health authorities and working together to
determine how they can be used to support the rollout of booster
doses around the world.”
“These important data add to the body of
evidence suggesting that a booster dose of our vaccine can help
protect a broad population of people from this virus and its
variants,” said Ugur Sahin, M.D., CEO and Co-Founder of
BioNTech. “Based on these findings we believe that, in addition
to broad global access to vaccines for everyone, booster
vaccinations could play an important role in sustaining pandemic
containment and a return to normalcy.”
All trial participants previously completed the
primary two-dose series of the Pfizer-BioNTech 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. During the study
period, there were 5 cases of COVID-19 in the boosted group, and
109 cases in the non-boosted group. The observed relative
vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the
reduction in disease occurrence in the boosted group versus the
non-boosted group in those without evidence of prior SARS-CoV-2
infection. 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 adverse event profile was generally
consistent with other clinical safety data for the vaccine, with no
safety concerns identified.
Pfizer and BioNTech plan to submit detailed
results from the trial for peer-reviewed publication. The companies
also plan to share these data with the U.S. Food and Drug
Administration, European Medicines Agency, and other regulatory
agencies around the world as soon as possible.
On September 22, 2021, a booster dose of the
Pfizer-BioNTech COVID-19 Vaccine was authorized for emergency use
by the U.S. FDA for 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. On October
20, 2021, a booster dose of the vaccine also was authorized for
emergency use by the U.S. FDA in eligible individuals who have
completed a primary vaccination with a different authorized
COVID-19 vaccine. In addition, a booster dose of the vaccine is
authorized in the European Union and other countries, with
recommendations for populations varying based on local health
authority guidance.
The Pfizer-BioNTech COVID-19 Vaccine, which is
based on BioNTech’s proprietary mRNA technology, was developed by
both BioNTech and Pfizer. BioNTech is the Marketing Authorization
Holder in the United States, the European Union, the United
Kingdom, Canada and the holder of emergency use authorizations or
equivalents in the United States (jointly with Pfizer) and other
countries. Submissions to pursue regulatory approvals in those
countries where emergency use authorizations or equivalent were
initially granted are planned.
U.S. Indication & Authorized UseHOW
IS THE VACCINE GIVEN?The vaccine will be given to you as an
injection into the muscle.
Primary Series: The vaccine is administered as a
2-dose series, 3 weeks apart. A third 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 to
individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- A single booster dose may be administered to eligible
individuals who have completed primary vaccination with a different
authorized COVID‑19 vaccine. Booster eligibility and schedule
are based on the labeling information of the vaccine used for the
primary series.
WHAT IS THE INDICATION AND AUTHORIZED USE?The
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same
formulation and can be used interchangeably. Although they may be
manufactured in different facilities, the products offer the same
safety and effectiveness.
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 be administered to provide:
-
-
a two-dose primary series in individuals 12 through 15 years;
-
a third primary series dose in individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise; and
-
a single booster dose in individuals:
-
65 years of age and older
-
18 through 64 years of age at high risk of severe COVID-19
-
18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
The Pfizer-BioNTech COVID-19 Vaccine has
received EUA from FDA to provide:
-
a two-dose primary series in individuals 12 years of age and
older;
-
a third primary series dose for individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise; and
-
a single booster dose in individuals:
-
65 years of age and older
-
18 through 64 years of age at high risk of severe COVID-19
-
18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have
completed primary vaccination with a different authorized
COVID‑19 vaccine. Booster eligibility and schedule are based
on the labeling information of the vaccine used for the primary
series.
EUA StatementEmergency uses of the
vaccine have not been approved or licensed by FDA, but have been
authorized by FDA, under an Emergency Use Authorization (EUA) to
prevent Coronavirus Disease 2019 (COVID-19) in
individuals 12 years of age and older. The emergency uses are
only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of the medical product under Section 564(b)(1) of the FD&C Act
unless the declaration is terminated or authorization revoked
sooner. Please see EUA Fact Sheet at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATIONIndividuals
should not get the Pfizer-BioNTech COVID-19 Vaccine if
they:
-
had a severe allergic reaction after a previous dose of this
vaccine
-
had a severe allergic reaction to any ingredient of this
vaccine
Individuals should tell the vaccination provider
about all of their medical conditions, including if they:
-
have any allergies
-
have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
-
have a fever
-
have a bleeding disorder or are on a blood thinner
-
are immunocompromised or are on a medicine that affects the immune
system
-
are pregnant, plan to become pregnant, or are breastfeeding
-
have received another COVID-19 vaccine
-
have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine
include:
-
There is a remote chance that the vaccine could cause a severe
allergic reaction▪ A severe allergic reaction would usually occur
within a few minutes to one hour after getting a dose of the
vaccine. For this reason, vaccination providers may ask individuals
to stay at the place where they received the vaccine for monitoring
after vaccination
-
Signs of a severe allergic reaction can include difficulty
breathing, swelling of the face and throat, a fast heartbeat, a bad
rash all over the body, dizziness, and weakness
-
If an individual experiences a severe allergic reaction, they
should call 9-1-1 or go to the nearest hospital
-
Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine. In most of these people,
symptoms began within a few days following receipt of the second
dose of the vaccine. The chance of having this occur is very low.
Individuals should seek medical attention right away if they have
any of the following symptoms after receiving the vaccine:
-
chest pain
-
shortness of breath
-
feelings of having a fast-beating, fluttering, or pounding
heart
-
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 your healthcare provider if you
have any side effects that bother you or do not go away
Data on administration of this vaccine at the
same time as other vaccines has 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 http://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.
Please click here for full Prescribing
Information (16+ years of age). Please click here for Fact Sheet
for Vaccination Providers (12+ years of age). Please click here for
the Recipients and Caregivers Fact Sheet.
About Pfizer: Breakthroughs That Change
Patients’ LivesAt Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us
on www.Pfizer.com and follow us on Twitter
at @Pfizer and @Pfizer
News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe information
contained in this release is as of October 21, 2021. Pfizer assumes
no obligation to update forward-looking statements contained in
this release as the result of new information or future events or
developments.
This release contains forward-looking
information about Pfizer’s efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine, the BNT162 mRNA vaccine program and COMIRNATY (COVID-19
Vaccine, mRNA) (BNT162b2) (including potential of booster
doses, 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 BNT162b2 in younger pediatric populations,
applications for a potential booster dose and/or other biologics
license and/or emergency use authorization applications or
amendments to any such applications may be filed in particular
jurisdictions for BNT162b2 or any other potential vaccines that may
arise from the BNT162 program, and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including the potential submissions for younger
pediatric populations, a potential booster dose or any other
requested amendments to the emergency use or conditional marketing
authorizations) or other vaccines that may result from the BNT162
program may be approved by particular regulatory authorities, which
will depend on myriad factors, including making a determination as
to whether the vaccine’s benefits outweigh its known risks and
determination of the vaccine’s efficacy and, if approved, whether
it will be commercially successful; decisions by regulatory
authorities impacting labeling or marketing, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of a vaccine, including
development of products or therapies by other companies;
disruptions in the relationships between us and our collaboration
partners, clinical trial sites or third-party suppliers; the risk
that demand for any products may be reduced or no longer exist;
risks related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, two-dose
schedule and attendant storage, distribution and administration
requirements, including risks related to storage and handling after
delivery by Pfizer; the risk that we may not be able to
successfully develop other vaccine formulations, booster doses or
new variant-specific vaccines; the risk that we may not be able to
create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether
and when additional supply agreements will be reached;
uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; challenges related to public vaccine
confidence or awareness; uncertainties regarding the impact of
COVID-19 on Pfizer’s business, operations and financial results;
and competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About BioNTechBiopharmaceutical New
Technologies is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company
exploits a wide array of computational discovery and therapeutic
drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and small molecules. Based on its deep expertise in mRNA
vaccine development and in-house manufacturing capabilities,
BioNTech and its collaborators are developing multiple mRNA vaccine
candidates for a range of infectious diseases alongside its diverse
oncology pipeline. BioNTech has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including Genmab, Sanofi, Bayer Animal Health, Genentech, a member
of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit www.BioNTech.de.
BioNTech Forward-looking StatementsThis
press release contains “forward-looking statements” of BioNTech
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to, statements concerning: BioNTech’s efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer including
the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19
Vaccine, mRNA) (BNT162b2) (including a potential booster dose and
emergency use authorization in the U.S. of a booster dose for
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 who have frequent institutional or
occupational exposure to SARS-CoV-2; 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; and the ability of BioNTech to supply the quantities
of BNT162 to support clinical development and market demand,
including our production estimates for 2021. Any forward-looking
statements in this press release are based on BioNTech's 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) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848IR@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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