- First participants enrolled in clinical trial received
Omicron-based vaccine candidate as a two-dose primary series and as
a booster dose
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the initiation of a clinical study to evaluate the
safety, tolerability and immunogenicity of an Omicron-based vaccine
candidate in healthy adults 18 through 55 years of age. The study
will have three cohorts examining different regimens of the current
Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The
study will draw upon some participants from the companies’ Phase 3
COVID-19 booster study and is part of their ongoing efforts to
address Omicron and determine the potential need for variant-based
vaccines.
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“While current research and real-world data show that boosters
continue to provide a high level of protection against severe
disease and hospitalization with Omicron, we recognize the need to
be prepared in the event this protection wanes over time and to
potentially help address Omicron and new variants in the future,”
said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of
Vaccine Research & Development at Pfizer. “Staying vigilant
against the virus requires us to identify new approaches for people
to maintain a high level of protection, and we believe developing
and investigating variant-based vaccines, like this one, are
essential in our efforts to towards this goal.”
“Vaccines continue to offer strong protection against severe
disease caused by Omicron. Yet, emerging data indicate
vaccine-induced protection against infection and mild to moderate
disease wanes more rapidly than was observed with prior strains,”
said Prof. Ugur Sahin, CEO and Co-founder of BioNTech. “This
study is part of our science-based approach to develop a
variant-based vaccine that achieves a similar level of protection
against Omicron as it did with earlier variants but with longer
duration of protection.”
The study will evaluate up to 1,420 participants across the
three cohorts:
- Cohort #1 (n = 615): Received two doses of the current
Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment;
in the study, participants will receive one or two doses of the
Omicron-based vaccine
- Cohort #2 (n = 600): Received three doses of the current
Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment;
in the study, participants will receive one dose of the current
Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine
- Cohort #3 (n=205): Vaccine-naïve participants will receive
three doses of the Omicron-based vaccine
Clinical and real-world data continue to find people who are
vaccinated, particularly those that have received a booster,
maintain a high level of protection against Omicron, particularly
against severe disease and hospitalization. The companies have
previously announced that they expect to produce four billion doses
of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity
is not expected to change if an adapted vaccine is required.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on
BioNTech’s proprietary mRNA technology, was developed by both
BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder
in the United States, the European Union, the United Kingdom,
Canada and other countries, and the holder of emergency use
authorizations or equivalents in the United States (jointly with
Pfizer) and other countries. Submissions to pursue regulatory
approvals in those countries where emergency use authorizations or
equivalent were initially granted are planned.
U.S. Indication & Authorized
Use HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series: In individuals 5 years of age and older, the
vaccine is administered as a 2-dose series, 3 weeks apart. In
individuals 5 years of age and older, a third primary series dose
may be administered at least 28 days after the second dose to
individuals who are determined to have certain kinds of
immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at
least 5 months after completion of a primary series of the
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine,
mRNA) to individuals 12 years of age and older
- A single booster dose of the vaccine may be administered to
individuals 18 years of age and older who have completed primary
vaccination with a different authorized COVID-19 vaccine.
Individuals should check with their healthcare provider regarding
timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA
to provide:
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 5 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19
vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in
individuals 16 years of age and older
- It is also authorized under EUA to provide:
- a 2-dose primary series to individuals 12 through 15 years of
age
- a third primary series dose to individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
- a single booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series
EUA Statement Emergency uses
of the vaccine have not been approved or licensed by FDA, but have
been authorized by FDA, under an Emergency Use Authorization (EUA)
to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5
years of age and older. The emergency uses are only authorized for
the duration of the declaration that circumstances exist justifying
the authorization of emergency use of the medical product under
Section 564(b)(1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see EUA Fact
Sheets at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATION
Individuals should not get the vaccine if they:
- had a severe allergic reaction after a previous dose of this
vaccine
- had a severe allergic reaction to any ingredient of this
vaccine
Individuals should tell the vaccination provider about all of
their medical conditions, including if they:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
- There is a remote chance that the vaccine could cause a severe
allergic reaction
- A severe allergic reaction would usually occur within a few
minutes to 1 hour after getting a dose of the vaccine. For this
reason, vaccination providers may ask individuals to stay at the
place where they received the vaccine for monitoring after
vaccination
- Signs of a severe allergic reaction can include difficulty
breathing, swelling of the face and throat, a fast heartbeat, a bad
rash all over the body, dizziness, and weakness
- If an individual experiences a severe allergic reaction, they
should call 9-1-1 or go to the nearest hospital
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine, more commonly in males
under 40 years of age than among females and older males. In most
of these people, symptoms began within a few days following receipt
of the second dose of the vaccine. The chance of having this occur
is very low. Individuals should seek medical attention right away
if they have any of the following symptoms after receiving the
vaccine:
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding
heart
- Additional side effects that have been reported with the
vaccine include:
- severe allergic reactions; non-severe allergic reactions such
as rash, itching, hives, or swelling of the face; myocarditis
(inflammation of the heart muscle); pericarditis (inflammation of
the lining outside the heart); injection site pain; tiredness;
headache; muscle pain; chills; joint pain; fever; injection site
swelling; injection site redness; nausea; feeling unwell; swollen
lymph nodes (lymphadenopathy); decreased appetite; diarrhea;
vomiting; arm pain; fainting in association with injection of the
vaccine
- These may not be all the possible side effects of the vaccine.
Serious and unexpected side effects may occur. The possible side
effects of the vaccine are still being studied in clinical trials.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other
vaccines have not yet been submitted to FDA. Individuals
considering receiving this vaccine with other vaccines, should
discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for
medical advice about adverse events. Individuals are encouraged to
report negative side effects of vaccines to the US Food and Drug
Administration (FDA) and the Centers for Disease Control and
Prevention (CDC). Visit https://www.vaers.hhs.gov or call
1-800-822-7967. In addition, side effects can be reported to Pfizer
Inc. at www.pfizersafetyreporting.com or by calling
1-800-438-1985.
Click for
Fact Sheets and Prescribing Information for
individuals 12 years of age and older
Full Prescribing Information (16 years of age
and older) DILUTE BEFORE USE, Purple Cap Full Prescribing
Information (16 years of age and older) DO NOT DILUTE, Gray Cap EUA
Fact Sheet for Vaccination Providers (12 years of age and older),
Purple Cap EUA Fact Sheet for Vaccination Providers (12 years of
age and older), Gray Cap Recipients and Caregivers Fact Sheet (12
years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5
through 11 years of age), Orange Cap Recipients and Caregivers Fact
Sheet (5 through 11 years of age)
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in
this release is as of January 25, 2022. 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 an
Omicron-based vaccine candidate and a study in adults 18 through 55
years of age, an expected multi-arm study in adults above 55 years
of age, BNT162b2’s potential against the Omicron variant,
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 or
a potential variant-based vaccine to prevent COVID-19 caused by
emerging virus variants; the risk that more widespread use of the
vaccine will lead to new information about efficacy, safety, or
other developments, including the risk of additional adverse
reactions, some of which may be serious; the risk that preclinical
and clinical trial data are subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether and when additional data from the BNT162 mRNA
vaccine program will be published in scientific journal
publications and, if so, when and with what modifications and
interpretations; whether regulatory authorities will be satisfied
with the design of and results from these and any future
preclinical and clinical studies; whether and when submissions to
request emergency use or conditional marketing authorizations for a
potential booster dose, pediatric populations and/or other
biologics license and/or emergency use authorization applications
or amendments to any such applications may be filed in particular
jurisdictions for BNT162b2 or any other potential vaccines that may
arise from the BNT162 program, including a potential variant-based
vaccine, and if obtained, whether or when such emergency use
authorizations or licenses will expire or terminate; whether and
when any applications that may be pending or filed for BNT162b2
(including any requested amendments to the emergency use or
conditional marketing authorizations) or other vaccines that may
result from the BNT162 program may be approved by particular
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the vaccine’s
benefits outweigh its known risks and determination of the
vaccine’s efficacy and, if approved, whether it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of
products or therapies by other companies; disruptions in the
relationships between us and our collaboration partners, clinical
trial sites or third-party suppliers; the risk that demand for any
products may be reduced or no longer exist; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s formulation, 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-based 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 potential of a
Omicron-specific COVID-19 vaccine candidate, the potential timing
for the development of a Omicron-specific COVID-19 vaccine
candidate, the testing of BNT162b2 against the Omicron variant, the
effectiveness of a third booster dose of BNT162b2 to induce
protection against Omicron-induced COVID-19 disease, and the timing
for assessment of the effectiveness of a variant-specific COVID-19
vaccine, 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 2022; 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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