Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based
COVID-19 Vaccine in Adults 18 to 55 Years of Age
- First participants enrolled in clinical trial received
Omicron-based vaccine candidate as a two-dose primary series and as
a booster dose
NEW YORK and MAINZ,
GERMANY, JANUARY 25, 2022 — 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.
“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 INFORMATIONIndividuals
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 forFact Sheets and Prescribing Information for individuals
12 years of age and olderFull 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 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’
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
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 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.
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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