NEW YORK and MAINZ, GERMANY, September 26, 2022 — Pfizer
Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced
they have completed a submission to the U.S. Food and Drug
Administration (FDA) requesting Emergency Use Authorization (EUA)
of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine for children 5 through 11 years of age.
The request for Emergency Use Authorization of the Omicron
BA.4/BA.5-adapted bivalent vaccine in this age group is supported
by safety and immunogenicity data from the companies’ Omicron
BA.1-adapted bivalent vaccine, non-clinical and manufacturing data
from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent
vaccine, and preclinical data from the companies’ Omicron
BA.4/BA.5-adapted bivalent vaccine. An application to extend the
Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization
in the European Union to include children 5 through 11 years of age
will be submitted to the European Medicines Agency (EMA) in the
coming days.
The companies have also initiated a Phase 1/2/3
study (NCT05543616, C4591048) to evaluate the safety, tolerability
and immunogenicity of different doses and dosing regimens of the
companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in
children 6 months through 11 years of age. This pediatric study is
consistent with regulatory guidance and follows a previous Phase
1/2/3 trial involving these age groups that demonstrated the
original Pfizer-BioNTech COVID-19 vaccine is well-tolerated and
offers a high level of protection against COVID-19, measured at a
time when the Omicron BA.2 strain was highly prevalent.
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 for BNT162b2 (COMIRNATY®) 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.
About the StudyThe Phase 1/2/3 pediatric
clinical study will have four substudies examining different
bivalent COVID-19 vaccine dose regimens and dose levels across
different ages, including:
- Substudy A (ages 6 through 23 months who are COVID-19
vaccine-naïve): Phase 1 dose-finding study will evaluate 3-µg,
6-µg and 10-µg dose levels of the bivalent vaccine. Based on Phase
1, participants in the Phase 2/3 will receive the selected dose as
a three-dose primary series, followed by a booster dose.
- Substudy B (ages 6 months through 4 years who previously
received 2-3 doses of original COVID-19 vaccine): Those who
have received two doses of the original COVID-19 vaccine prior to
enrollment will receive both a third and fourth 3-µg dose of the
bivalent vaccine. Those who have previously received three doses of
the original vaccine will receive a 3-µg booster (fourth) dose of
the bivalent vaccine.
- Substudy C (ages 6 months through 4 years who previously
received 3 doses of original COVID-19 vaccine): Phase 1
dose-finding study will evaluate 6-µg and 10-µg dose levels of the
bivalent vaccine as a fourth dose. Based on Phase 1, Phase 2/3 will
receive the selected dose as a fourth dose.
- Substudy D (ages 5 through 11 years who previously received
2-3 doses of original COVID-19 vaccine): Participants will
receive the bivalent vaccine as either a third or fourth 10-µg
booster dose.
U.S. INDICATION & AUTHORIZED USE
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON
BA.4/BA.5) AUTHORIZED USES
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and
Omicron BA.4/BA.5) is FDA-authorized under Emergency Use
Authorization (EUA) for use in individuals 12 years of age and
older as a single booster dose administered at least 2 months after
either:
- completion of primary vaccination with any authorized or
approved monovalent* COVID-19 vaccine; or
- receipt of the most recent booster dose with any authorized or
approved monovalent COVID-19 vaccine.
*Monovalent refers to any authorized and approved COVID-19
vaccine that contains or encodes the spike protein of only the
Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine, mRNA)
INDICATIONCOMIRNATY® (COVID-19 Vaccine, mRNA) is a
vaccine approved for active immunization to prevent coronavirus
disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and
older.
COMIRNATY® AUTHORIZED USESCOMIRNATY® (COVID-19
Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization
(EUA) to provide:
Primary Series
- a third primary series dose to individuals 12 years of age and
older who have certain kinds of immunocompromise
PFIZER-BIONTECH COVID-19 VACCINE AUTHORIZED
USES
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under
Emergency Use Authorization (EUA) for use in individuals 6 months
and older to provide:Primary Series
- a 3-dose primary series to individuals 6 months through 4 years
of age
- a 2-dose primary series to individuals 5 years through 11 years
of age
- a third primary series dose to individuals 5 years through 11
years of age with certain kinds of immunocompromise
Booster
- a single booster dose to individuals 5 through 11 years of age
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
EMERGENCY USE AUTHORIZATION
Emergency uses of the original and bivalent
vaccines 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 6 months of age and older (original vaccine)
- individuals 12 years of age and older (bivalent
vaccine)
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.
IMPORTANT SAFETY INFORMATION
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and
Omicron BA.4/BA.5), COMIRNATY® (COVID-19 Vaccine, mRNA) and
Pfizer-BioNTech COVID-19 Vaccine
Tell your vaccination provider about all of your medical
conditions, including if you:
- 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
- COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may not
protect all vaccine recipients.
- You should not receive Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5) if you have had a severe
allergic reaction to after a previous dose of COMIRNATY (COVID-19
Vaccine, mRNA) or the Pfizer-BioNTech COVID 19 Vaccine or had a
severe allergic reaction to any ingredient in these
vaccines
- There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5) 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, your vaccination provider may ask you to stay at
the place where you received the vaccine for monitoring after
vaccination. If you experience a severe allergic reaction, call
9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the
following symptoms: difficulty breathing, swelling of the face
and throat, a fast heartbeat, a bad rash all over the body,
dizziness, and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received COMIRNATY® (COVID-19 vaccine, mRNA)
or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher
among adolescent males and adult males under 40 years of age than
among females and older males, and the observed risk is highest in
males 12 through 17 years of age. In most of these people, symptoms
began within the first week following receipt of the second primary
series dose or first booster dose, with most booster doses
administered at least 5 months after completing primary
vaccination. The chance of having this occur is very
low.
Side effects that have been reported with these vaccines
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
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
These may not be all the possible side effects of the vaccine.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away.
- Individuals should always ask their healthcare providers for
medical advice about adverse events. Report vaccine side effects to
the US Food and Drug Administration (FDA) and the Centers for
Disease Control and Prevention (CDC) Vaccine Adverse Event
Reporting System (VAERS). The VAERS toll-free number is
1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. In addition, individuals can
report side effects to Pfizer Inc. at www.pfizersafetyreporting.com
or by calling 1-800-438-1985
Click for Fact Sheets and Prescribing
Information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5):EUA Fact Sheet for Recipients and
Caregivers (12 years of age and older)EUA Fact Sheet for
Vaccination Providers (12 Years & Up), BIVALENT (Original and
Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap
Click for Fact Sheets and Prescribing
Information for individuals 5 years of age and older:Recipients and
Caregivers Fact Sheet (6 months through 4 years of age)Recipients
and Caregivers Fact Sheet (5 through 11 years of age)Recipients and
Caregivers Fact Sheet (12 years of age and older)COMIRNATY® Full
Prescribing Information (12 years of age and older), DILUTE BEFORE
USE, Purple CapCOMIRNATY® Full Prescribing Information (12 years of
age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for
Vaccination Providers (6 months through 4 years of age), DILUTE
BEFORE USE, Maroon CapEUA Fact Sheet for Vaccination Providers (5
through 11 years of age), DILUTE BEFORE USE, Orange CapEUA Fact
Sheet for Vaccination Providers (12 years of age and older), DILUTE
BEFORE USE, Purple CapEUA Fact Sheet for Vaccination Providers (12
years of age and older), DO NOT DILUTE, Gray Cap
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 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 September 26, 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 BA.4/BA.5-adapted bivalent
COVID-19 vaccine candidate, including submissions to the FDA and
EMA for an Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine candidate for children ages 5 through 11 years of age and a
Phase 1/2/3 study in children aged 6 months through 11 years of
age, qualitative assessments of available data, potential benefits,
expectations for clinical trials, potential regulatory submissions,
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 Phase
1/2/3 or Phase 4 data), including the data discussed in this
release for BNT162b2, any monovalent, bivalent or variant-adapted
vaccine candidates or any other vaccine candidate in the BNT162
program in any of our studies in pediatrics, adolescents, or adults
or real world evidence, 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, in real world data studies or in larger, more diverse
populations following commercialization; the ability of BNT162b2,
any monovalent, bivalent or variant-adapted vaccine candidates or
any future 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
BNT162b2 in additional populations, for a potential booster dose
for BNT162b2, any monovalent or bivalent vaccine candidates or any
potential future vaccines (including potential future annual
boosters or re-vaccination), 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,
any monovalent or bivalent vaccine candidates or any other
potential vaccines that may arise from the BNT162 program,
including a potential variant-based, higher dose, or bivalent
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), any monovalent or bivalent
vaccine candidates (including the submissions to the FDA and EMA
for an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
candidate), 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
which may lead to reduced revenues or excess inventory; risks
related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, dosing
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
potential future annual boosters or re-vaccinations or new
variant-based or next generation vaccines; the risk that we may not
be able to maintain 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, 2021 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 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, bispecific immune checkpoint 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, Genentech, a member of the
Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For
more information, please visit www.BioNTech.com.
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 emergency use authorization in the U.S.
for persons 5 years of age and older of an Omicron-adapted COVID-19
bivalent vaccine based on the BA.4/BA.5 subvariant and planned
regulatory submissions, 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, any monovalent or bivalent vaccine candidates or any
future vaccine, in our clinical trials and/or in commercial use
based on data observations to date; the ability of BNT162b2, any
monovalent or bivalent vaccine candidates or any future vaccine, to
prevent COVID-19 caused by emerging virus variants; 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 Phase
1/2/3 or Phase 4 data), including the data discussed in this
release for BNT162b2, any monovalent or bivalent vaccine candidates
or any other vaccine candidate in BNT162 program in any of our
studies in pediatrics, adolescents, or adults or real world
evidence, including the possibility of unfavorable new preclinical,
clinical or safety data and further analyses of existing
preclinical, clinical or safety data; the expected time point for
additional readouts on efficacy data of BNT162b2, any monovalent or
bivalent vaccine candidates or any future vaccine, in our clinical
trials; 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 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, any monovalent or bivalent
vaccine candidates or any future vaccine, to support clinical
development and market demand, including our production estimates
for 2022; that demand for any products may be reduced or no longer
exist which may lead to reduced revenues or excess inventory; the
availability of raw materials to manufacture a vaccine; our
vaccine’s formulation, dosing schedule and attendant storage,
distribution and administration requirements, including risks
related to storage and handling after delivery by Pfizer; the
ability to successfully develop other vaccine formulations, booster
doses or potential future annual boosters or re-vaccinations or new
variant-based vaccines; the ability to maintain 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; 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; 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 Quarterly Report as Form 6-K for the
quarter ended June 30, 2022, filed with the SEC on August 8, 2022,
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.
CONTACT:
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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