SILVER SPRING, Md.,
Feb. 27, 2021 /PRNewswire/ -- Today,
the U.S. Food and Drug Administration issued an emergency use
authorization (EUA) for the third vaccine for the prevention
of coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the
Janssen COVID-19 Vaccine to be distributed in the U.S for use in
individuals 18 years of age and older.
"The authorization of this vaccine expands the availability
of vaccines, the best medical prevention method for COVID-19, to
help us in the fight against this pandemic, which has claimed over
half a million lives in the United
States," said Acting FDA Commissioner Janet Woodcock, M.D. "The FDA, through our open
and transparent scientific review process, has now authorized three
COVID-19 vaccines with the urgency called for during this pandemic,
using the agency's rigorous standards for safety, effectiveness and
manufacturing quality needed to support emergency use
authorization."
The FDA has determined that the Janssen COVID-19 Vaccine has met
the statutory criteria for issuance of an EUA. The totality of the
available data provides clear evidence that the Janssen COVID-19
Vaccine may be effective in preventing COVID-19. The data also show
that the vaccine's known and potential benefits outweigh its known
and potential risks, supporting the company's request for the
vaccine's use in people 18 years of age and older. 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 information.
The Janssen COVID-19 Vaccine is manufactured using a specific
type of virus called adenovirus type 26 (Ad26). The vaccine uses
Ad26 to deliver a piece of the DNA, or genetic material, that is
used to make the distinctive "spike" protein of the SARS-CoV-2
virus. While adenoviruses are a group of viruses that are
relatively common, Ad26, which can cause cold symptoms and pink
eye, has been modified for the vaccine so that it cannot replicate
in the human body to cause illness. After a person receives this
vaccine, the body can temporarily make 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.
"After a thorough analysis of the data, the FDA's scientists
and physicians have determined that the vaccine meets the FDA's
expectations for safety and effectiveness appropriate for the
authorization of a vaccine for emergency use," said Peter Marks, M.D., Ph.D., director of the FDA's
Center for Biologics Evaluation and Research. "With today's
authorization, we are adding another vaccine in our medical toolbox
to fight this virus. At the same time, the American people can be
assured of the FDA's unwavering commitment to public health through
our comprehensive and rigorous evaluation of the data submitted for
vaccines to prevent COVID-19."
FDA Evaluation of Available Safety Data
The Janssen COVID-19 Vaccine is administered as a single dose.
The available safety data to support the EUA include an analysis of
43,783 participants enrolled in an ongoing randomized,
placebo-controlled study being conducted in South Africa, certain countries in
South America, Mexico, and the U.S. The participants, 21,895
of whom received the vaccine and 21,888 of whom received saline
placebo, were followed for a median of eight weeks after
vaccination. The most commonly reported side effects were pain at
the injection site, headache, fatigue, muscle aches and nausea.
Most of these side effects were mild to moderate in severity and
lasted 1-2 days.
As part of the authorization, the FDA notes that it is mandatory
for Janssen Biotech Inc. and vaccination providers to report the
following to the Vaccine Adverse Event Reporting System (VAERS) for
Janssen COVID-19 Vaccine: serious adverse events, cases of
Multisystem Inflammatory Syndrome and cases of COVID-19 that result
in hospitalization or death.
It is also mandatory for vaccination providers to report all
vaccine administration errors to VAERS for which they become aware
and for Janssen Biotech Inc. to include a summary and analysis of
all identified vaccine administration errors in monthly safety
reports submitted to the FDA.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA include an analysis of
39,321 participants in the ongoing randomized, placebo-controlled
study being conducted in South
Africa, certain countries in South
America, Mexico, and the
U.S. who did not have evidence of SARS-CoV-2 infection prior to
receiving the vaccine. Among these participants, 19,630 received
the vaccine and 19,691 received saline placebo. Overall, the
vaccine was approximately 67% effective in preventing moderate to
severe/critical COVID-19 occurring at least 14 days after
vaccination and 66% effective in preventing moderate to
severe/critical COVID-19 occurring at least 28 days after
vaccination.
Additionally, the vaccine was approximately 77% effective in
preventing severe/critical COVID-19 occurring at least 14 days
after vaccination and 85% effective in preventing severe/critical
COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that
occurred at least 14 days after vaccination, and 348 cases of
COVID-19 in the placebo group during this time period. There were
66 cases of COVID-19 in the vaccine group that occurred at least 28
days after vaccination and 193 cases of COVID-19 in the placebo
group during this time period. Starting 14 days after vaccination,
there were 14 severe/critical cases in the vaccinated group versus
60 in the placebo group, and starting 28 days after vaccination,
there were 5 severe/critical in the vaccine group versus 34 cases
in the placebo group.
At this time, data are not available to determine 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 Feb. 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
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 alternatives.
The issuance of an EUA is different than an FDA approval
(licensure) of a vaccine, in that a vaccine available under an EUA
is not approved. In determining whether to issue an EUA for a
product, the FDA evaluates the available evidence to determine
whether the product may be effective and also assesses any known or
potential risks and any known or potential benefits If the product
meets the effectiveness standard and 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 Janssen COVID-19 Vaccine, be made
available to vaccination providers and vaccine recipients.
Janssen Biotech Inc. has submitted a pharmacovigilance plan to
the FDA describing its commitment to monitor the safety of Janssen
COVID-19 Vaccine. The pharmacovigilance plan includes a plan to
complete longer-term 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
Janssen COVID-19 Vaccine and ensuring that any safety concerns are
identified and evaluated in a timely manner.
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 Janssen COVID-19 Vaccine was issued to Janssen
Biotech Inc., a Janssen Pharmaceutical Company of Johnson &
Johnson. The authorization 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. The EUA for Janssen COVID-19 Vaccine may
be revised or revoked if it is determined the EUA no longer meets
the statutory criteria for issuance.
Additional Resources:
- Janssen COVID-19 Vaccine EUA Letter of Authorization
- Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare
Providers
- Janssen COVID-19 EUA Fact Sheet for Recipients and
Caregivers
- COVID-19 Vaccines
- Emergency Use Authorization for Vaccines Explained
- Emergency Use Authorization for Vaccines to Prevent COVID-19;
Guidance for Industry
- Development and Licensure of Vaccines to Prevent COVID-19;
Guidance for Industry
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: Email or 888-INFO-FDA
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.
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SOURCE U.S. Food and Drug Administration