- EUA is based on data that show children 5 through 11 years of
age had a robust immune response with a favorable safety profile
following a 10-µg booster dose of the Pfizer-BioNTech COVID-19
Vaccine at a time when Omicron was the prevalent variant
- Children 5 through 11 years of age now authorized to receive a
booster dose at least five months after the second dose of the
two-dose primary series
- To date, 4,500 children 5 through 11 years of age have
participated in the companies’ COVID-19 vaccine clinical trial
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the U.S. Food and Drug Administration (FDA) expanded
emergency use authorization (EUA) to include a booster dose after
completion of the primary series of the Pfizer-BioNTech COVID-19
Vaccine in children 5 through 11 years of age. The booster dose is
given at least five months after the second dose of the two-dose
primary series and is the same 10-µg dose of the Pfizer-BioNTech
COVID-19 Vaccine. To date, more than 8 million 5- to 11-year-olds
in the U.S. have completed a primary series.1
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220516005789/en/
The expanded EUA is based on data from the Phase 2/3 clinical
trial, which showed that a booster dose of the Pfizer-BioNTech
COVID-19 Vaccine elicited a strong immune response in this age
group, generating neutralizing antibodies against both the Omicron
variant and wild-type SARS-CoV-2 virus regardless of prior
SARS-CoV-2 infection. No new safety signals were observed. The
third dose was well tolerated, with a safety profile similar to the
two-dose primary series.
This Phase 2/3 data builds on efficacy data for the primary
two-dose series which showed 90.7% efficacy in children 5 through
11 without prior SARS-CoV-2 infection, measured from 7 days after
the second dose, at a period when Delta was the prevalent
strain.
The companies have already submitted an application to the
European Medicines Agency for a booster dose in this age group and
are planning to file with other regulatory agencies around the
world. The Pfizer-BioNTech COVID-19 Vaccine is the only COVID-19
vaccine authorized for use in the U.S. for children 5 through 11
years of age.
The Phase 1/2/3 clinical trial evaluating the safety,
tolerability, and immunogenicity of a 3-µg formulation of the
Pfizer-BioNTech COVID-19 Vaccine on a three-dose schedule in
children ages 6 months through 4 years (also known as under 5) is
ongoing. Initial data is expected in the coming weeks.
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 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 Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled up to 4,500 children
ages 6 months to under 12 years of age in the United States,
Finland, Poland, and Spain from more than 90 clinical trial sites.
Additional children have been enrolled in all age groups following
study amendments and the trial currently includes more than 10,000
children. The trial was originally designed to evaluate the safety,
tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19
Vaccine on a two-dose schedule (approximately 21 days apart) in
three age groups: ages 5 to under 12 years; ages 2 to under 5
years; and ages 6 months to under 2 years. Based on the Phase 1
dose-escalation portion of the trial, children ages 5 to under 12
years received a two-dose schedule of 10 µg each while children
under age 5 received a lower 3-µg dose for each injection in the
Phase 2/3 study. The trial enrolled children with or without prior
evidence of SARS-CoV-2 infection. In December 2021, Pfizer and
BioNTech announced the companies would test a third 3-µg dose given
at least two months after the second dose in children under age 5
and a third dose of the 10-µg formulation in children 5 to under 12
years of age.
U.S. Indication & 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 5
years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA
authorized to provide:
Primary Series
- 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 with certain kinds of immunocompromise
Booster Series
- a single booster dose to individuals 5 through 11 years of age
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
- a first 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 first booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
or approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
- a second booster dose to individuals 50 years of age and older
who have received a first booster dose of any authorized or
approved COVID-19 vaccine
- a second booster dose to individuals 12 years of age and older
with certain kinds of immunocompromise and who have received a
first booster dose of any authorized or approved COVID-19
vaccine
COMIRNATY® 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 16 years of age and older.
- COMIRNATY® is administered as a 2-dose primary
series
COMIRNATY® AUTHORIZED USES
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized
under Emergency Use Authorization (EUA) to provide:
Primary Series
- 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 with certain kinds of immunocompromise
Booster Dose
- a first booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- a first booster dose to individuals 18 years of age and older
who have completed primary vaccination with another authorized or
approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
- a second booster dose to individuals 50 years of age and older
who have received a first booster dose of any authorized or
approved COVID-19 vaccine
- a second booster dose to individuals 12 years of age and older
with certain kinds of immunocompromise and who have received a
first booster dose of any authorized or approved COVID-19
vaccine
Emergency Use
Authorization
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 either individuals 12 years of age and older, or in individuals
5 through 11 years of age, as appropriate. 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.
INTERCHANGEABILITY
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use
Authorization (EUA) for individuals 12 years of age and older can
be used interchangeably by a vaccination provider when prepared
according to their respective instructions for use.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine
authorized for use in children 5 through 11 years of age differs
from the formulations authorized for individuals 12 years of age
and older and should therefore not be used interchangeably. The
Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5
through 11 years of age should not be used interchangeably with
COMIRNATY® (COVID-19 Vaccine, mRNA).
IMPORTANT SAFETY
INFORMATION
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
- Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19
Vaccine, mRNA) may not protect all vaccine recipients
- You should not receive Pfizer-BioNTech COVID-19 Vaccine
or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have 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 or COMIRNATY®
- There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine
or COMIRNATY® (COVID-19 Vaccine, mRNA) 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 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 Seek medical attention right away if you 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
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
(COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and
hurt themselves. For this reason, your vaccination provider may ask
you 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 or
COMIRNATY® (COVID-19 Vaccine, mRNA)
- Additional side effects include injection site pain; tiredness;
headache; muscle pain; chills; joint pain; fever; injection site
swelling; injection site redness; nausea; rash; feeling unwell;
swollen lymph nodes (lymphadenopathy); decreased appetite;
diarrhea; vomiting; arm pain; and fainting in association with
injection of the vaccine
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
Click for Fact Sheets and Prescribing Information for
individuals 5 years of age and older:
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 (16
years of age and older), DILUTE BEFORE USE, Purple Cap COMIRNATY®
Full Prescribing Information (16 years of age and older), DO NOT
DILUTE, Gray 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 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 May XX, 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 emergency
use authorization in the U.S. of a booster dose after completion of
the primary series of the Pfizer-BioNTech COVID-19 Vaccine in
children 5 through 11 years of age, potential data readout of a
Phase 1/2/3 clinical trial evaluating a vaccine for children 6
months through 4 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) 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 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 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 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 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) 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, 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 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, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer. For more information, please visit
www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of
BioNTech within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may include,
but may not be limited to, statements concerning: BioNTech’s
efforts to combat COVID-19; the collaboration between BioNTech and
Pfizer including the program to develop a COVID-19 vaccine and
COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including emergency
use authorization in the U.S. of a booster dose after completion of
the primary series of the Pfizer-BioNTech COVID-19 Vaccine in
children 5 through 11 years of age, potential data readout of a
Phase 1/2/3 clinical trial evaluating a vaccine for children 6
months through 4 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; 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 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 BNT162, or any future vaccine, in additional
populations, or receipt of, any marketing approval or emergency use
authorization or equivalent, including or amendments or variations
to such authorizations; 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 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; 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 Annual Report as Form 20-F for the Year Ended December
31, 2021, 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.
1 Centers for Disease Control and Prevention. COVID-19
Vaccination Demographics in the United States,National. Available
at:
https://data.cdc.gov/Vaccinations/COVID-19-Vaccination-Demographics-in-the-United-St/km4m-vcsb/data.
Accessed May 11, 2022.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220516005789/en/
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
Pfizer (NYSE:PFE)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
Von Apr 2023 bis Apr 2024