Coronavirus (COVID-19) Update: FDA
Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and
Immunocompromised Individuals
Today, the U.S. Food and Drug Administration authorized a second
booster dose of either the Pfizer-BioNTech or the Moderna COVID-19
vaccines for older people and certain immunocompromised individuals. The
FDA previously authorized a single booster dose for certain
immunocompromised individuals following completion of a three-dose
primary vaccination series. This action will now make a second booster
dose of these vaccines available to other populations at higher risk for
severe disease, hospitalization and death. Emerging evidence suggests
that a second booster dose of an mRNA COVID-19 vaccine improves
protection against severe COVID-19 and is not associated with new safety
concerns.
The agency amended the emergency use authorizations as follows:
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or
Moderna COVID-19 Vaccine may be administered to individuals 50 years of
age and older at least 4 months after receipt of a first booster dose
of any authorized or approved COVID-19 vaccine.
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may
be administered to individuals 12 years of age and older with certain
kinds of immunocompromise at least 4 months after receipt of a first
booster dose of any authorized or approved COVID-19 vaccine. These are
people who have undergone solid organ transplantation, or who are living
with conditions that are considered to have an equivalent level of
immunocompromise.
A second booster dose of the Moderna COVID-19 Vaccine may be
administered at least 4 months after the first booster dose of any
authorized or approved COVID-19 vaccine to individuals 18 years of age
and older with the same certain kinds of immunocompromise.
“Current evidence suggests some waning of protection
over time against serious outcomes from COVID-19 in older and
immunocompromised individuals. Based on an analysis of emerging data, a
second booster dose of either the Pfizer-BioNTech or Moderna COVID-19
vaccine could help increase protection levels for these higher-risk
individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s
Center for Biologics Evaluation and Research. “Additionally, the data
show that an initial booster dose is critical in helping to protect all
adults from the potentially severe outcomes of COVID-19. So, those who
have not received their initial booster dose are strongly encouraged to
do so.”
Today’s action applies only to the Pfizer-BioNTech and Moderna
COVID-19 vaccines and the authorization of a single booster dose for
other age groups with these vaccines remains unchanged. The agency will
continue to evaluate data and information as it becomes available when
considering the potential use of a second booster dose in other age
groups.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the
FDA-approved Comirnaty can be used to provide the authorized booster
dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the
FDA-approved Spikevax are authorized to provide the authorized booster
dose(s).
Information to Support Authorization of a Second COVID-19 Booster Dose
The FDA has determined that the known and potential benefits of a
second COVID-19 vaccine booster dose with either of these vaccines
outweigh their known and potential risks in these populations. The
evidence considered for authorization of a second booster dose following
primary vaccination and first booster dose included safety and immune
response information provided to the agency as well as additional
information on effectiveness submitted by the companies.
A summary of safety surveillance data provided to the FDA by the
Ministry of Health of Israel on the administration of approximately
700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19
Vaccine given at least 4 months after the third dose in adults 18 years
of age and older (approximately 600,000 of whom were 60 years of age or
older) revealed no new safety concerns.
The safety of Moderna COVID-19 Vaccine, when administered as a second
booster dose, is informed by experience with the Pfizer-BioNTech
COVID-19 Vaccine and safety information reported from an independently
conducted study in which the Moderna COVID-19 Vaccine was administered
as a second booster dose to 120 participants 18 years of age and older
who had received a two-dose primary series and a first booster dose of
Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety
concerns were reported during up to three weeks of follow up after the
second booster dose.
Immunogenicity data from an ongoing, open-label, non-randomized
clinical study in healthcare workers at a single center in Israel were
reported in a publication provided to the FDA. In this study,
individuals 18 years of age and older who had received primary
vaccination and a first booster dose with Pfizer-BioNTech COVID-19
Vaccine were administered a second booster dose of Pfizer-BioNTech
COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120
individuals) at least four months after the first booster dose. Among
these individuals, increases in neutralizing antibody levels against
SARS-CoV-2 virus, including delta and omicron variants were reported two
weeks after the second booster as compared to 5 months after the first
booster dose.
The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.
