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FDA Approves First COVID-19 Vaccine
Published: August 24, 2021
at 09:30 a.m.
By: Press Release from FDA (August 23, 2021)
FDA NEWS RELEASE
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health
Today, the U.S.
Food and Drug Administration approved the first COVID-19 vaccine. The
vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine,
and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in
individuals 16 years of age and older. The vaccine also continues to be
available under emergency use authorization (EUA), including for
individuals 12 through 15 years of age and for the administration of a
third dose in certain immunocompromised individuals.
“The FDA’s
approval of this vaccine is a milestone as we continue to battle the
COVID-19 pandemic. While this and other vaccines have met the FDA’s
rigorous, scientific standards for emergency use authorization, as the
first FDA-approved COVID-19 vaccine, the public can be very confident that
this vaccine meets the high standards for safety, effectiveness, and
manufacturing quality the FDA requires of an approved product,” said Acting
FDA Commissioner Janet Woodcock, M.D. “While millions of people have already
safely received COVID-19 vaccines, we recognize that for some, the FDA
approval of a vaccine may now instill additional confidence to get
vaccinated. Today’s milestone puts us one step closer to altering the
course of this pandemic in the U.S.”
Since Dec. 11,
2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in
individuals 16 years of age and older, and the authorization was expanded
to include those 12 through 15 years of age on May 10, 2021. EUAs can be
used by the FDA during public health emergencies to provide access to
medical products that may be effective in preventing, diagnosing, or
treating a disease, provided that the FDA determines that the known and
potential benefits of a product, when used to prevent, diagnose, or treat
the disease, outweigh the known and potential risks of the product.
FDA-approved
vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all
vaccines, the FDA evaluates data and information included in the
manufacturer’s submission of a biologics license application (BLA). A BLA
is a comprehensive document that is submitted to the agency providing very
specific requirements. For Comirnaty, the BLA builds on the extensive data
and information previously submitted that supported the EUA, such as
preclinical and clinical data and information, as well as details of the
manufacturing process, vaccine testing results to ensure vaccine quality,
and inspections of the sites where the vaccine is made. The agency conducts
its own analyses of the information in the BLA to make sure the vaccine is
safe and effective and meets the FDA’s standards for approval.
Comirnaty
contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used
by the body to make a mimic of one of the proteins in the virus that causes
COVID-19. The result of a person receiving this vaccine is that their
immune system will ultimately react defensively to the virus that causes
COVID-19. The mRNA in Comirnaty is only present in the body for a short
time and is not incorporated into - nor does it alter - an individual’s
genetic material. Comirnaty has the same formulation as the EUA vaccine and
is administered as a series of two doses, three weeks apart.
“Our scientific and
medical experts conducted an incredibly thorough and thoughtful evaluation
of this vaccine. We evaluated scientific data and information included in
hundreds of thousands of pages, conducted our own analyses of Comirnaty’s
safety and effectiveness, and performed a detailed assessment of the
manufacturing processes, including inspections of the manufacturing
facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for
Biologics Evaluation and Research. “We have not lost sight that the COVID-19
public health crisis continues in the U.S. and that the public is counting
on safe and effective vaccines. The public and medical community can be
confident that although we approved this vaccine expeditiously, it was
fully in keeping with our existing high standards for vaccines in the
U.S."
FDA Evaluation of
Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA,
issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16
years of age and older was based
on safety and effectiveness data from a randomized, controlled,
blinded ongoing clinical trial of thousands of individuals.
To support the
FDA’s approval decision today, the FDA reviewed updated data from the
clinical trial which supported the EUA and included a longer duration of
follow-up in a larger clinical trial population.
Specifically, in
the FDA’s review for approval, the agency analyzed effectiveness data from
approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and
older who did not have evidence of the COVID-19 virus infection within a
week of receiving the second dose. The safety of Comirnaty was evaluated in
approximately 22,000 people who received the vaccine and 22,000 people who
received a placebo 16 years of age and older.
Based on results
from the clinical trial, the vaccine was 91% effective in preventing
COVID-19 disease.
More than half of
the clinical trial participants were followed for safety outcomes for at
least four months after the second dose. Overall, approximately 12,000
recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical
trial participants who received Comirnaty were pain, redness and swelling
at the injection site, fatigue, headache, muscle or joint pain, chills, and
fever. The vaccine is effective in preventing COVID-19 and potentially
serious outcomes including hospitalization and death.
Additionally, the
FDA conducted a rigorous evaluation of the post-authorization safety
surveillance data pertaining to myocarditis and pericarditis following
administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined
that the data demonstrate increased risks, particularly within the seven
days following the second dose. The observed risk is higher among males
under 40 years of age compared to females and older males. The observed
risk is highest in males 12 through 17 years of age. Available data from
short-term follow-up suggest that most individuals have had resolution of
symptoms. However, some individuals required intensive care support.
Information is not yet available about potential long-term health outcomes.
The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety
Monitoring
The FDA and
Centers for Disease Control and Prevention have monitoring systems in place
to ensure that any safety concerns continue to be identified and evaluated
in a timely manner. In addition, the FDA is requiring the company to
conduct postmarketing studies to further assess
the risks of myocarditis and pericarditis following vaccination with
Comirnaty. These studies will include an evaluation of long-term outcomes
among individuals who develop myocarditis following vaccination with
Comirnaty. In addition, although not FDA requirements, the company has
committed to additional post-marketing safety studies, including conducting
a pregnancy registry study to evaluate pregnancy and infant outcomes after
receipt of Comirnaty during pregnancy.
The FDA granted
this application Priority
Review. The approval was granted to BioNTech Manufacturing GmbH.
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