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FDA Takes Key Action in Fight Against COVID-19 By Issuing
Emergency Use Authorization for First COVID-19 Vaccine
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing
Quality Information by FDA Career Scientists, Input from Independent Experts
For Immediate Release:
December 11, 2020
Español (/news-events/press-announcements/la-fda-toma-accion-clave-en-la-lucha-contra-el-covid-19-al-emitir-una-autorizacion-de-uso-de)

Today, the U.S. Food and Drug Administration issued the first emergency use authorization
(EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and
older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be
distributed in the U.S.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a
significant milestone in battling this devastating pandemic that has affected so
many families in the United States and around the world,” said FDA
Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and
transparent review process that included input from independent scientific and
public health experts and a thorough evaluation by the agency’s career scientists to
ensure this vaccine met FDA’s rigorous, scientific standards for safety,
effectiveness, and manufacturing quality needed to support emergency use
authorization. The tireless work to develop a new vaccine to prevent this novel,
serious, and life-threatening disease in an expedited timeframe after its
emergence is a true testament to scientific innovation and public-private
collaboration worldwide.”
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria
for issuance of an EUA. The totality of the available data provides clear evidence that PfizerBioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support
that the known and potential benefits outweigh the known and potential risks, supporting the
vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In
making this determination, the FDA can assure the public and medical community that it has
conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic
material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs
cells in the body to make the virus’s distinctive “spike” protein. When a person receives this
vaccine, their body produces copies of the spike protein, which does not cause disease, but
triggers the immune system to learn to react defensively, producing an immune response
against SARS-CoV-2.
“While not an FDA approval, today’s emergency use authorization of the PfizerBioNTech COVID-19 Vaccine holds the promise to alter the course of this
pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the
FDA’s Center for Biologics Evaluation and Research. “With science guiding our
decision-making, the available safety and effectiveness data support the
authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s
known and potential benefits clearly outweigh its known and potential risks. The
data provided by the sponsor have met the FDA’s expectations as conveyed in our
June and October guidance documents. Efforts to speed vaccine development have
not sacrificed scientific standards or the integrity of our vaccine evaluation
process. The FDA’s review process also included public and independent review
from members of the agency’s Vaccines and Related Biological Products Advisory
Committee. Today’s achievement is ultimately a testament to the commitment of
our career scientists and physicians, who worked tirelessly to thoroughly evaluate
the data and information for this vaccine.”
FDA Evaluation of Available Safety Data
Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart.
The available safety data to support the EUA include 37,586 of the participants enrolled in an
ongoing randomized, placebo-controlled international study, the majority of whom are U.S.
participants. These participants, 18,801 of whom received the vaccine and 18,785 of whom
received saline placebo, were followed for a median of two months after receiving the second
dose. The most commonly reported side effects, which typically lasted several days, were pain at
the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more
people experienced these side effects after the second dose than after the first dose, so it is
important for vaccination providers and recipients to expect that there may be some side effects
after either dose, but even more so after the second dose.
It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine
Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine
administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome
(MIS), and cases of COVID-19 that result in hospitalization or death.
FDA Evaluation of Available Effectiveness Data

The effectiveness data to support the EUA include an analysis of 36,523 participants in the
ongoing randomized, placebo-controlled international study, the majority of whom are U.S.
participants, who did not have evidence of SARS-CoV-2 infection through seven days after the
second dose. Among these participants, 18,198 received the vaccine and 18,325 received
placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical
trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group.
Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were
classified as severe. At this time, data are not available to make a determination about how long
the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission
of SARS-CoV-2 from person to person.
The EUA Process
On the basis of the determination by the Secretary of the Department of Health and Human
Services on February 4, 2020, that there is a public health emergency that has a significant
potential to affect national security or the health and security of United States citizens living
abroad, and then issued declarations that circumstances exist justifying the authorization of
emergency use of unapproved products, the FDA may issue an EUA to allow unapproved
medical products or unapproved uses of approved medical products to be used in an emergency
to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available
The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. In
determining whether to issue an EUA for a product, the FDA evaluates the available evidence
and assesses any known or potential risks and any known or potential benefits, and if the
benefit-risk assessment is favorable, the product is made available during the emergency. Once
a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then
evaluates the request and determines whether the relevant statutory criteria are met, taking into
account the totality of the scientific evidence about the vaccine that is available to the FDA.
The EUA also requires that fact sheets that provide important information, including dosing
instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19
Vaccine, be made available to vaccination providers and vaccine recipients.
The company has submitted a pharmacovigilance plan to FDA to monitor the safety of PfizerBioNTech COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longerterm safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance
plan also includes other activities aimed at monitoring the safety profile of the Pfizer-BioNTech
COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to
continue their clinical trials to obtain additional safety and effectiveness information and pursue
approval (licensure).
The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be
effective until the declaration that circumstances exist justifying the authorization of the
emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated,
and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria
for issuance.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for regulating tobacco products.

 FDA O ce of Media Affairs (
 301-796-4540
 888-INFO-FDA

Related Information
Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Patients
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