- In a Phase 3 trial, the vaccine was 100% effective and
generally well tolerated in participants aged 12 to 15 years
- Data also submitted to European Medicines Agency (EMA) and
other global regulators, with additional authorizations expected in
coming weeks
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced
today that the U.S. Food and Drug Administration (FDA) has expanded
the Emergency Use Authorization (EUA) for their COVID-19 vaccine to
include individuals 12 to 15 years of age. This is the first
COVID-19 vaccine authorized in the U.S. for use in this age
group.
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“Today’s expansion of our EUA represents a significant step
forward in helping the U.S. government broaden its vaccination
program and help protect adolescents before the start of the next
school year,” said Albert Bourla, Chairman and Chief Executive
Officer, Pfizer. “We are grateful to all of our clinical trial
volunteers and their families, whose courage helped make this
milestone possible. Together, we hope to help bring a sense of
normalcy back to young people across the country and around the
world.”
The FDA based its decision on data from a pivotal Phase 3
clinical trial, which enrolled 2,260 participants aged 12 to 15
years. Topline results from this trial, announced on March 31,
2021, showed a vaccine efficacy of 100% in participants with or
without prior SARS-CoV-2 infection and robust antibody responses.
In the trial, the vaccine was also generally well tolerated.
Participants will continue to be monitored for long-term protection
and safety for an additional two years after their second dose.
As a next step following today’s FDA decision, the U.S. Centers
for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) will meet to discuss recommendations
for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12
to 15 years of age based on the amended EUA.
“Since securing the EUA in December for individuals 16 years and
older, we have been working tirelessly to get our COVID-19 vaccine
authorized around the world so that governments can provide it to
as many people as possible,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “Our work is not yet complete, as we
continue our research into the use of our vaccine in pediatric
populations. Our goal is to submit data for pre-school and
school-age children in September.”
Pfizer and BioNTech have submitted the data in adolescents 12 to
15 years of age for scientific peer review for potential
publication. The data also have been submitted to other regulators
around the world, including the European Medicines Agency
(EMA).
In addition, the pediatric study evaluating the safety and
efficacy of the Pfizer-BioNTech COVID-19 Vaccine in children 6
months to 11 years of age is ongoing. Pfizer and BioNTech expect to
have definitive readouts and, subject to the data generated, submit
for an EUA or a variation to Conditional Marketing Authorizations
for two cohorts, including children 2-5 years of age and 5-11 years
of age, in September. The readout and submission for the cohort of
children 6 months to 2 years of age are expected in the fourth
quarter.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech
proprietary mRNA technology, was developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder in the
European Union, and the holder of emergency use authorizations or
equivalents in the United States (together with Pfizer), United
Kingdom, Canada and other countries in advance of a planned
application for full marketing authorizations in these
countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or
licensed by the U.S. Food and Drug Administration (FDA), but has
been authorized for emergency use by FDA under an Emergency Use
Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) for use in individuals 12 years of age and older. The
emergency use of this product is only authorized for the duration
of the declaration that circumstances exist justifying the
authorization of emergency use of the medical product under Section
564 (b) (1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see Emergency
Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) and Full EUA
Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under
an 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 12
years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE
AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer‑BioNTech COVID-19 Vaccine to
individuals with known history of a severe allergic reaction (eg,
anaphylaxis) to any component of the Pfizer‑BioNTech COVID-19
Vaccine
- Appropriate medical treatment used to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of
Pfizer‑BioNTech COVID-19 Vaccine
Monitor Pfizer-BioNTech COVID-19 Vaccine
recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control and Prevention
guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)
- Syncope (fainting) may occur in association with administration
of injectable vaccines, in particular in adolescents. Procedures
should be in place to avoid injury from fainting
- Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
the Pfizer‑BioNTech COVID-19 Vaccine
- The Pfizer‑BioNTech COVID-19 Vaccine may not protect all
vaccine recipients
- In clinical studies, adverse reactions in participants 16 years
of age and older included pain at the injection site (84.1%),
fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills
(31.9%), joint pain (23.6%), fever (14.2%), injection site swelling
(10.5%), injection site redness (9.5%), nausea (1.1%), malaise
(0.5%), and lymphadenopathy (0.3%)
- In a clinical study, adverse reactions in adolescents 12
through 15 years of age included pain at the injection site
(90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle
pain (42.2%), fever (24.3%), joint pain (20.2%), injection site
swelling (9.2%), injection site redness (8.6%), lymphadenopathy
(0.8%), and nausea (0.4%)
- Severe allergic reactions, including anaphylaxis, and other
hypersensitivity reactions, diarrhea, vomiting, and pain in
extremity (arm) have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials
Additional adverse reactions, some of which
may be serious, may become apparent with more widespread use of the
Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer‑BioNTech COVID-19 Vaccine administered
to pregnant women are insufficient to inform vaccine-associated
risks in pregnancy
- Data are not available to assess the effects of Pfizer‑BioNTech
COVID-19 Vaccine on the breastfed infant or on milk
production/excretion
- There are no data available on the interchangeability of the
Pfizer‑BioNTech COVID‑19 Vaccine with other COVID-19 vaccines to
complete the vaccination series. Individuals who have received one
dose of Pfizer‑BioNTech COVID-19 Vaccine should receive a second
dose of Pfizer‑BioNTech COVID-19 Vaccine to complete the
vaccination series
- Vaccination providers must report Adverse Events in accordance
with the Fact Sheet to VAERS online at
https://vaers.hhs.gov/reportevent.html. For further assistance with
reporting to VAERS call 1-800-822-7967. The reports should include
the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description
section of the report
- Vaccination providers should review the Fact Sheet for
Information to Provide to Vaccine Recipients/Caregivers and
Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization
- Before administration of Pfizer-BioNTech COVID-19 Vaccine,
please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including Full EUA Prescribing Information available at
www.cvdvaccine-us.com
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 10, 2021.
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 BNT162 mRNA vaccine
program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)
(including qualitative assessments of available data, potential
benefits, expectations for clinical trials, the potential of
BNT162b2 for adolescents 12 to 15 years of age, evaluation of
BNT162b2 in children 6 months to 11 years old, anticipated timing
of regulatory submissions, regulatory approvals or authorizations
and anticipated manufacturing, distribution and supply) involving
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
risks associated with preclinical and clinical data (including the
topline data outlined in this release), including the possibility
of unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data
(including the topline data outlined 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 or in larger, more diverse populations following
commercialization; the ability of BNT162b2 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 (including the topline data
outlined in this release) 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 (including the topline data outlined in this
release) 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 a Biologics License Application for
BNT162b2 may be filed in the U.S. and whether and when 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, and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including a potential Biologics License
Application in the U.S. or 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 ultra-low temperature formulation,
two-dose 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; the risk that
we may not be able to create or scale up manufacturing capacity on
a timely basis or maintain access to logistics or supply channels
commensurate with global demand for our vaccine, which would
negatively impact our ability to supply the estimated numbers of
doses of our vaccine within the projected time periods as
previously indicated; whether and when additional supply agreements
will be reached; uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; challenges related
to public vaccine confidence or awareness; uncertainties regarding
the impact of COVID-19 on Pfizer’s business, operations and
financial results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. The Company exploits a wide array of
computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking 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 to develop a COVID-19 vaccine (including a potential second
booster dose of BNT162b2 and/or a potential booster dose of a
variation of BNT162b2 having a modified mRNA sequence); the
potential of BNT162b2 for adolescents 12 to 15 years of age,
evaluation of BNT162b2 in children 6 months to 11 years old,
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply); our expectations regarding the potential characteristics
of BNT162b2 in our clinical trials and/or in commercial use based
on data observations to date; the ability of BNT162b2 to prevent
COVID-19 caused by emerging virus variants; the expected time point
for additional readouts on efficacy data of BNT162b2 in our
clinical trials; the nature of the clinical data, which is subject
to ongoing peer review, regulatory review and market
interpretation; the timing for submission of data for, or receipt
of, any marketing approval or Emergency Use Authorization; our
contemplated shipping and storage plan, including our estimated
product shelf life at various temperatures; the risk that demand
for any products may be reduced or no longer exist; the ability of
BioNTech to supply the quantities of BNT162 to support clinical
development and market demand, including our production estimates
for 2021; and challenges related to public vaccine confidence or
awareness. Any forward-looking statements in this press release are
based on BioNTech’s 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 on Form 20-F for the Year Ended December
31, 2020, filed with the SEC on March 30, 2021, which is available
on the SEC’s website at www.sec.gov. All information in this press
release is as of the date of the release, and BioNTech undertakes
no duty to update this information unless required by law.
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Pfizer Contacts:
Media Relations Amy Rose +1 (212) 733-7410 Amy.Rose@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
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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