- 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
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.
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“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 booster 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
Use HOW 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
- 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.
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 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 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 INFORMATION
Individuals 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’ 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 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 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 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.
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Pfizer: Media Relations +1 (212) 733-1226
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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