- Bivalent vaccine authorized as third 3-µg dose in the
three-dose primary series
- Consistent COVID-19 hospitalization rates in this age group
coupled with an overall surge in respiratory illnesses among
children under 5 in the United States creates urgent need to make
updated COVID-19 vaccines available
- Doses to ship immediately upon recommendation by CDC
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the U.S. Food and Drug Administration (FDA) granted
Emergency Use Authorization (EUA) of their Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose
in the three-dose primary series for children 6 months through 4
years of age. Children in this age group can receive a primary
series consisting of two 3-µg doses of the original Pfizer-BioNTech
COVID-19 Vaccine followed by a third 3-µg dose of the bivalent
vaccine to complete the primary series. Vaccine doses can be
delivered immediately upon receipt of a recommendation from the
U.S. Centers for Disease Control and Prevention ("CDC").
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221208005574/en/
On top of a persistent stream of COVID-19 cases, surging
seasonal respiratory illnesses in young children are straining
health systems across the U.S., with many states reporting more
than 90% of their pediatric hospital beds are occupied.iii Updated
COVID-19 vaccines may improve protection against severe illness and
hospitalization caused by SARS-CoV-2 in this age group.
“This authorization offers an opportunity for parents to help
better protect their young children against COVID-19, including
disease caused by Omicron sublineages,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “Nearly 40 million
Americans have received a booster dose of an updated vaccine. It is
critical that we all continue to do our part to help protect
ourselves by staying up to date with COVID-19 vaccinations, as
recommended by public health authorities, especially now as we plan
to gather for the holidays and head into the winter season.”
“As the virus evolves it remains our goal to be able to provide
access to variant-adapted vaccines against COVID-19 to a broader
population,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of
BioNTech. “With this authorization, the adapted vaccine based on
the Omicron sublineages BA.4 and BA.5 can become an important part
of the primary vaccination series for young children."
The amendment to the EUA is supported by clinical data from
adults who received the Omicron BA.4/BA.5-adapted bivalent vaccine,
post-authorization experience with this bivalent vaccine among ages
5 years and older, and post-authorization experience with the
original Pfizer-BioNTech COVID-19 Vaccine as a three-dose primary
series for children 6 months through 4 years of age. Additional
support is provided by clinical data from the companies’ Omicron
BA.1-adapted bivalent vaccine in adults as well as pre-clinical and
manufacturing data from the companies’ 3-µg Omicron
BA.4/BA.5-adapted bivalent vaccine. The Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine is currently authorized as a booster dose
for ages 5 years and older in the U.S. and European Union (EU).
An application to extend Pfizer and BioNTech’s Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization
in the EU to include children ages 6 months through 4 years is
under discussion with the European Medicines Agency (EMA).
The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) are based on
BioNTech’s proprietary mRNA technology and were developed by both
BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder
for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron
BA.4/BA.5) 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.
U.S. INDICATION & AUTHORIZED
USE
Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Original and
Omicron BA.4/BA.5)
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized
under Emergency Use Authorization (EUA) for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6
months through 11 years of age.
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized
to provide:
Primary Series
- 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
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is FDA
authorized to provide:
Booster Dose
- a single booster dose to individuals 5 through 11 years of age
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19
Vaccine, Bivalent are authorized to provide:
- a 3-dose primary series to individuals 6 months through 4 years
of age as follows:
- Dose 1: Pfizer-BioNTech COVID-19 Vaccine
- Dose 2: Pfizer-BioNTech COVID-19 Vaccine
- Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent
EMERGENCY USE AUTHORIZATION
Emergency uses of the 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 aged 6 months 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.
IMPORTANT SAFETY INFORMATION
Tell your vaccination provider about all the vaccine
recipient’s medical conditions, including if the vaccine
recipient:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or is on a blood thinner
- is immunocompromised or is on a medicine that affects the
immune system
- is pregnant, plans to become pregnant, or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
- Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine
recipients
- The vaccine recipient should not receive Pfizer-BioNTech
COVID-19 Vaccine if the vaccine recipient had a severe allergic
reaction to any of its ingredients or had a severe allergic
reaction to a previous dose of Pfizer-BioNTech COVID-19
Vaccine
- There is a remote chance that Pfizer-BioNTech COVID-19 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, your vaccination provider may
ask the vaccine recipient to stay at the place where the vaccine
was administered for monitoring after vaccination. If the vaccine
recipient experiences a severe allergic reaction, call 9-1-1 or go
to the nearest hospital Seek medical attention right away if the
vaccine recipient has 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 a few days following receipt of the second dose of
vaccine. The chance of having this occur is very low
Seek medical attention right away if the vaccine recipient
has any of the following symptoms:
- Chest pain
- Shortness of breath or difficulty breathing
- Feelings of having a fast-beating, fluttering, or pounding
heart
- Fainting
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Persistent vomiting
- Persistent pain in the abdomen
- Unusual and persistent cool, pale skin
- Dizziness
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine. Sometimes people who
faint can fall and hurt themselves. For this reason, your
vaccination provider may ask the vaccine recipient to sit or lie
down for 15 minutes after receiving the vaccine
- Some people with weakened immune systems may have reduced
immune responses to Pfizer-BioNTech COVID-19 Vaccine
- Additional side effects include rash, itching, hives, swelling
of the face, injection site pain, tiredness, feeling weak or lack
of energy, 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, dizziness and irritability
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.
- You should always ask your 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. You can also report
side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by
calling 1-800-438-1985
Fact Sheets for individuals 6 months through 11 years of
age:
EUA Recipients and Caregivers Fact Sheet (6 months through 4
years of age)
EUA Recipients and Caregivers Fact Sheet (5 through 11 years
of age)
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 (5 through 11 years
of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE
USE, Orange 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 December 8, 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 EUA in
the U.S. for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5) as the third 3-µg dose in the
three-dose primary series for children 6 months through 4 years of
age, planned regulatory submissions, 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, including the risk that additional data
against newer Omicron sublineages could differ from the data
discussed in this release; 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-vaccinations), 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 submission in the EU for an
Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine), 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 vaccines, which would negatively impact our ability to supply
the estimated numbers of doses of our vaccines within the projected
time periods; 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 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 Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine, submission to the FDA for an Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose
in the three-dose primary series for children under 5 years of age,
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, real world data studies, and/or in commercial
use based on data observations to date; preclinical and clinical
data (including Phase 1/2/3 or Phase 4 data), including the
descriptive data discussed in this release, for BNT162b2 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, including the risk that final or formal results
from the clinical trial could differ from the topline data; the
ability of BNT162b2 or a future vaccine to prevent COVID-19 caused
by emerging virus variants; the expected time point for additional
readouts on efficacy data of BNT162b2 and its adapted vaccine
variations in our clinical trials; the nature of the clinical data,
which is subject to ongoing peer review, regulatory review and
market interpretation; widespread use of BNT162b2 and its adapted
vaccine variations 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 timing for
submission of data for BNT162, or any future vaccine, in additional
populations, ( potential future annual boosters or
re-vaccinations), or receipt of, any marketing approval or
emergency use authorization or equivalent, including or amendments
or variations to such authorizations, 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; the
development of other vaccine formulations, booster doses or
potential future annual boosters or re-vaccinations or new variant
based vaccines; 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 and its
adapted vaccine variations to support clinical development and
market demand, including our production estimates for 2022;
challenges related to public vaccine confidence or awareness;
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; the availability of raw material to manufacture BNT162
or other vaccine formulation; 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; 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
September 30, 2022, filed with the SEC on November 7, 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.
______________ i U.S. Department of Health & Human Services.
COVID-19 Reported Patient Impact and Hospital Capacity by State.
Available at:
https://healthdata.gov/dataset/COVID-19-Reported-Patient-Impact-and-Hospital-Capa/6xf2-c3ie
ii Open letter by Mark Wietecha, CEO of Children’s Hospital
Association and Mark Del Monte, JD, CEO of American Academy of
Pediatrics. Available at:
https://downloads.aap.org/DOFA/Final%20AAP-CHA%20emergency%20declaration%20request%2011-14-22.pdf?_ga=2.102761028.596846312.1670424107-410496428.1670424107
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221208005574/en/
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
Pfizer (NYSE:PFE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Sep 2023 to Sep 2024