NEW YORK and MAINZ, GERMANY, May 7, 2021 (GLOBE NEWSWIRE) --
Pfizer Inc. (NYSE: PFE) and
BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics
License Application (BLA) with the U.S. Food and Drug Administration
(FDA) for approval of their mRNA vaccine to prevent COVID-19 in
individuals 16 years of age and older. Data to support the BLA will be
submitted by the Companies to the FDA on a rolling basis over the coming
weeks, with a request for Priority Review. The Prescription Drug User
Fee Act (PDUFA) goal date for a decision by the FDA will be set once the
BLA is complete and formally accepted for review by the agency.
The Pfizer-BioNTech COVID-19 vaccine is currently available in the U.S.
under an Emergency Use Authorization (EUA)
granted by the FDA on December 11, 2020. Since then, the Companies have
delivered more than 170 million doses of the vaccine across the U.S.
Submission of a BLA, which requires longer-term follow-up data for
acceptance and approval, is the next step in the rigorous FDA review
"We are proud of the tremendous progress we've made since December in
delivering vaccines to millions of Americans, in collaboration with the
U.S. Government," said Albert Bourla, Chairman and Chief Executive
Officer, Pfizer. "We look forward to working with the FDA to complete
this rolling submission and support their review, with the goal of
securing full regulatory approval of the vaccine in the coming months."
"Following the successful delivery of more than 170 million doses to the
U.S. population in just a few months, the BLA submission is an important
cornerstone of achieving long-term herd immunity and containing COVID-19
in the future," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
"We are pleased to work with U.S. regulators to seek approval of our
COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and
clinical data needed to support licensure of the COVID-19 vaccine for
use in individuals 16 years of age and older. This includes
the most recent analyses from the pivotal Phase 3 clinical trial, where
the vaccine's efficacy and favorable safety profile were observed up to
6 months after the second dose. The Companies will submit the required
manufacturing and facility data for licensure in the coming weeks to
complete the BLA.
Pfizer and BioNTech also have submitted an application to expand the
current EUA for their COVID-19 vaccine to include individuals 12 to 15
years of age. The Companies intend to submit a supplemental BLA to
support licensure of the vaccine in this age group once the required
data 6 months after the second vaccine dose are available.
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 equivalent 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) for use in individuals 16
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
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 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 16 years of age and
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION
-- Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with
known history of a severe allergic reaction (e.g., 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/
-- 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
-- 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%).
-- Severe allergic reactions, including anaphylaxis, have been reported
following the Pfizer-BioNTech COVID-19 vaccine during mass vaccination
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
-- Available data on Pfizer-BioNTech COVID-19 vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks in
-- 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 at https://vaers.hhs.gov/reportevent.html
https://vaers.hhs.gov/reportevent.html or by calling 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
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) including Full
EUA Prescribing Information available at
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
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May 07, 2021 06:45 ET (10:45 GMT)