FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines
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This action includes authorizing the current
bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all
doses administered to individuals 6 months of age and older, including for an
additional dose or doses for certain populations. The monovalent Moderna and
Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the
United States.
What You Need to Know:
Most individuals, depending on age,
previously vaccinated with a monovalent COVID-19 vaccine who
have not yet received a dose of a bivalent vaccine may receive a single dose of
a bivalent vaccine.
Most individuals who have already
received a single dose of the bivalent vaccine are
not currently eligible for another dose. The FDA intends to make decisions
about future vaccination after receiving recommendations on the fall strain
composition at an FDA advisory committee in June.
Individuals 65 years of age and older
who have received a single dose of a bivalent vaccine may
receive one additional dose at least four months following their initial
bivalent dose.
Most individuals with certain kinds of
immunocompromise who have received a bivalent COVID-19 vaccine may
receive a single additional dose of a bivalent COVID-19 vaccine at least 2
months following a dose of a bivalent COVID-19 vaccine, and additional doses may
be administered at the discretion of, and at intervals determined by, their
healthcare provider. However, for immunocompromised individuals 6 months
through 4 years of age, eligibility for additional doses will depend on the
vaccine previously received.
Most unvaccinated individuals may
receive a single dose of a bivalent vaccine, rather than multiple doses of the
original monovalent mRNA vaccines.
Children 6 months through 5 years of age
who are unvaccinated may receive a two-dose series of
the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose
series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of
age). Children who are 5 years of age may receive two doses of the Moderna
bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent
vaccine.
Children 6 months through 5 years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.
“At this stage of the pandemic, data support simplifying
the use of the authorized mRNA bivalent COVID-19 vaccines and the agency
believes that this approach will help encourage future vaccination,” said Peter
Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and
Research. “Evidence is now available that most of the U.S. population 5 years
of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19,
either from vaccination or infection that can serve as a foundation for the
protection provided by the bivalent vaccines. COVID-19 continues to be a very
real risk for many people, and we encourage individuals to consider staying
current with vaccination, including with a bivalent COVID-19 vaccine. The
available data continue to demonstrate that vaccines prevent the most serious
outcomes of COVID-19, which are severe illness, hospitalization, and death.”
Available data show that almost all of the U.S. population 5
years of age and older now have antibodies as a result of either vaccination or
infection against SARS-CoV-2. The use of bivalent COVID-19 vaccines for all
doses administered to individuals 6 months of age and older is supported by the
data described below, as well as post-marketing data, including real-world
data, with the monovalent and bivalent mRNA COVID-19 vaccines, which have been
administered to millions of people, including young children. A second bivalent
dose for individuals 65 years of age and older is supported by data showing the
waning of immunity in this population over time and its restoration by an
additional dose. Additionally, based on evidence from studies conducted
previously, immunocompromised individuals may require additional doses.
Moderna COVID-19 Vaccine, Bivalent
The safety and effectiveness of Moderna COVID-19 Vaccine,
Bivalent is based on FDA’s previous analyses of clinical trials data of
monovalent Moderna COVID-19 Vaccine in individuals 6 months of age and older
and an investigational bivalent Moderna COVID-19 vaccine (original and omicron
BA.1) in individuals 18 years of age and older.
In addition, effectiveness of a single dose is supported by the
FDA’s analysis of immune response data from clinical studies in which 145
individuals 6 years of age and older who had evidence of prior SARS-CoV-2
infection and 1,376 individuals 6 years of age and older without evidence of
prior SARS-CoV-2 infection had received two doses of monovalent Moderna
COVID-19 Vaccine. The immune response after one dose of vaccine among
participants with evidence of prior infection was comparable to the immune
response after two doses among participants without evidence of prior
infection.
The data accrued with the investigational bivalent Moderna
COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna
COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because
these vaccines are manufactured using the same process.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
The safety and effectiveness of Pfizer-BioNTech COVID-19
Vaccine, Bivalent is based on the FDA’s previous analyses of clinical trials
data of monovalent Pfizer-BioNTech COVID-19 Vaccine for use in individuals 6
months of age and older, an investigational bivalent Pfizer-BioNTech COVID-19 vaccine
(original and omicron BA.1) in individuals greater than 55 years of age, as
well as safety data with Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original
and omicron BA.4/BA.5) in individuals 6 months of age and older and immune
response data in individuals 6 months through 4 years of age.
In addition, effectiveness of a single dose is supported by
observational data from England on the effectiveness of one dose of monovalent
Pfizer-BioNTech COVID-19 Vaccine. Among individuals 12 to 17 years of age who
had received only one dose of Pfizer-BioNTech COVID-19 Vaccine, those who had
evidence of previous infection with alpha, delta or omicron variants had
increased protection against symptomatic omicron infection compared with those
with no evidence of previous infection.
The data accrued with the investigational Pfizer-BioNTech
bivalent COVID-19 vaccine (original and omicron BA.1) and with the monovalent
Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19
Vaccine, Bivalent because these vaccines are manufactured using the same
process.
With today’s authorizations, the fact sheets have been updated
and consolidated for the Moderna COVID-19 Vaccine, Bivalent and the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Each vaccine now has one fact sheet
for healthcare providers and one fact sheet for recipients and caregivers,
rather than different fact sheets for the various authorized age groups.
Vaccines and Related Biological Products Advisory
Committee
Today’s authorizations follow discussions that occurred during a
meeting with the FDA’s Vaccines and Related Biological Products Advisory
Committee (VRBPAC) on Jan. 26. At that time, by a unanimous vote, the committee
recommended harmonizing the strain composition of COVID-19 vaccines used in the
U.S. There was also support for simplifying the vaccine dosing schedule.
In June, the FDA will hold a meeting of its VRBPAC to discuss
the strain composition of the COVID-19 vaccines for fall of 2023. Much like the
FDA does yearly with the influenza vaccines, the agency will seek input from
the committee on which SARS-CoV-2 variants and lineages are most likely to
circulate in the upcoming year. Once the specific strains are selected for the
COVID-19 vaccines, the FDA expects manufacturers to make updated formulations
of the vaccines for availability this fall.
The amendments to the EUAs were issued to ModernaTX Inc. and
Pfizer Inc.
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