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 ages 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’ bivalent Omicron BA.1-adapted vaccine, non-clinical
and manufacturing data from the companies’ 10-µg bivalent Omicron
BA.4/BA.5-adapted vaccine, and pre-clinical data from the
companies’ Omicron BA.4/BA.5-adapted vaccine in their decision. An
application to extend the Omicron BA.4/BA.5-adapted bivalent
vaccine marketing authorization to include children ages 5 through
11 years will be submitted to the European Medicines Agency (EMA)
in the coming days.
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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 Study
The Phase 1/2/3 pediatric clinical study will have four
substudies examining different bivalent vaccine dosing regimens,
dose levels and 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 had 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 had 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 for 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 had 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) INDICATION
COMIRNATY® (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 USES
COMIRNATY® (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 Cap
COMIRNATY® Full Prescribing Information (12 years of age and
older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (6 months through 4
years of age), DILUTE BEFORE USE, Maroon Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of
age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and
older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and
older), DO NOT DILUTE, Gray Cap
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 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 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 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 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.
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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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