FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose
For Immediate Release:
Today, the U.S. Food and Drug Administration amended the emergency
use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the
Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of
the vaccines for use as a single booster dose at least two months
following primary or booster vaccination. The bivalent vaccines, which
we will also refer to as “updated boosters,” contain two messenger RNA
(mRNA) components of SARS-CoV-2 virus, one of the original strain of
SARS-CoV-2 and the other one in common between the BA.4 and BA.5
lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a
single booster dose in individuals 18 years of age and older. The
Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a
single booster dose in individuals 12 years of age and older.
The monovalent COVID-19 vaccines that are authorized or approved by
the FDA and have been administered to millions of people in the United
States since December 2020 contain a component from the original strain
of SARS-CoV-2.
What you need to know:
The authorized bivalent COVID-19 vaccines, or updated boosters,
include an mRNA component of the original strain to provide an immune
response that is broadly protective against COVID-19 and an mRNA
component in common between the omicron variant BA.4 and BA.5 lineages
to provide better protection against COVID-19 caused by the omicron
variant.
The BA.4 and BA.5 lineages of the omicron variant are currently
causing most cases of COVID-19 in the U.S. and are predicted to
circulate this fall and winter. In June, the agency’s Vaccines and
Related Biological Products Advisory Committee voted overwhelmingly to
include an omicron component in COVID-19 booster vaccines.
For each bivalent COVID-19 vaccine, the FDA based its decision on
the totality of available evidence, including extensive safety and
effectiveness data for each of the monovalent mRNA COVID-19 vaccines,
safety and immunogenicity data obtained from a clinical study of a
bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1
lineage that is similar to each of the vaccines being authorized, and
nonclinical data obtained using a bivalent COVID-19 vaccine that
contained mRNA of the original strain and mRNA in common between the
BA.4 and BA.5 lineages of the omicron variant.
Based on the data supporting each of these authorizations, the
bivalent COVID-19 vaccines are expected to provide increased protection
against the currently circulating omicron variant. Individuals who
receive a bivalent COVID-19 vaccine may experience side effects commonly
reported by individuals who receive authorized or approved monovalent
mRNA COVID-19 vaccines.
With today’s authorization, the monovalent mRNA COVID-19 vaccines
are not authorized as booster doses for individuals 12 years of age and
older.
The agency will work quickly to evaluate future data and
submissions to support authorization of bivalent COVID-19 boosters for
additional age groups as we receive them.
Who is eligible to receive a single booster dose and when:
Individuals 18 years of age and older are eligible for a single
booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at
least two months since they have completed primary vaccination or have
received the most recent booster dose with any authorized or approved
monovalent COVID-19 vaccine.
Individuals 12 years of age and older are eligible for a single
booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has
been at least two months since they have completed primary vaccination
or have received the most recent booster dose with any authorized or
approved monovalent COVID-19 vaccine.
“The COVID-19 vaccines, including boosters, continue to save
countless lives and prevent the most serious outcomes (hospitalization
and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D.
“As we head into fall and begin to spend more time indoors, we strongly
encourage anyone who is eligible to consider receiving a booster dose
with a bivalent COVID-19 vaccine to provide better protection against
currently circulating variants.”
The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech
COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus. The
mRNA in these vaccines is a specific piece of genetic material that
instructs cells in the body to make the distinctive “spike” protein of
the original virus strain and the omicron variant lineages BA.4 and
BA.5. The spike proteins of BA.4 and BA.5 are identical.
“The FDA has been planning for the possibility that the
composition of the COVID-19 vaccines would need to be modified to
address circulating variants. We sought input from our outside experts
on the inclusion of an omicron component in COVID-19 boosters to provide
better protection against COVID-19. We have worked closely with the
vaccine manufacturers to ensure the development of these updated
boosters was done safely and efficiently. The FDA has extensive
experience with strain changes for annual influenza vaccines. We are
confident in the evidence supporting these authorizations,” said Peter
Marks, M.D., Ph.D., director of the FDA’s Center for Biologics
Evaluation and Research. “The public can be assured that a great deal of
care has been taken by the FDA to ensure that these bivalent COVID-19
vaccines meet our rigorous safety, effectiveness and manufacturing
quality standards for emergency use authorization.”
For each of the bivalent COVID-19 vaccines authorized today, the FDA
evaluated immunogenicity and safety data from a clinical study of a
booster dose of a bivalent COVID-19 vaccine that contained a component
of the original strain of SARS-CoV-2 and a component of omicron lineage
BA.1. The FDA considers such data as relevant and supportive of vaccines
containing a component of the omicron variant BA.4 and BA.5 lineages.
Furthermore, data pertaining to the safety and effectiveness of the
current mRNA COVID-19 vaccines, which have been administered to millions
of people, including during the omicron waves of COVID-19, contributed
to the agency’s evaluation.
Data Supporting the Moderna COVID-19 Vaccine, Bivalent Authorization
To evaluate the effectiveness of a single booster dose of the Moderna
COVID-19 Vaccine, Bivalent for individuals 18 years of age and older,
the FDA analyzed immune response data among approximately 600
individuals 18 years of age and older who had previously received a
two-dose primary series and one booster dose of monovalent Moderna
COVID-19 Vaccine. These participants received a second booster dose of
either the monovalent Moderna COVID-19 Vaccine or Moderna’s
investigational bivalent COVID-19 vaccine (original and omicron BA.1) at
least 3 months after the first booster dose. After 28 days, the immune
response against BA.1 of the participants who received the bivalent
vaccine was better than the immune response of those who had received
the monovalent Moderna COVID-19 Vaccine.
The safety of a single booster dose of the Moderna COVID-19 Vaccine,
Bivalent for individuals 18 years of age and older is supported by
safety data from a clinical study which evaluated a booster dose of
Moderna’s investigational bivalent COVID-19 vaccine (original and
omicron BA.1), safety data from clinical trials which evaluated primary
and booster vaccination with the monovalent Moderna COVID-19 Vaccine,
and postmarketing safety data with the monovalent Moderna COVID-19
Vaccine.
The safety data accrued with the bivalent 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.
The clinical study that evaluated the safety of a booster dose of the
bivalent vaccine (original and omicron BA.1) included approximately 800
participants 18 years of age and older who had previously received a
two dose primary series and one booster dose of the monovalent Moderna
COVID-19 Vaccine, and then at least 3 months later, received a second
booster dose with either the monovalent Moderna COVID-19 Vaccine or
Moderna’s investigational bivalent COVID-19 vaccine (original and
omicron BA.1).
Among the study participants who received the bivalent vaccine, the
most commonly reported side effects included pain, redness and swelling
at the injection site, fatigue, headache, muscle pain, joint pain,
chills, swelling of the lymph nodes in the same arm of the injection,
nausea/vomiting and fever.
Data Supporting the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Authorization
To evaluate the effectiveness of a single booster dose of the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of
age and older, the FDA analyzed immune response data among approximately
600 adults greater than 55 years of age who had previously received a
2-dose primary series and one booster dose with the monovalent
Pfizer-BioNTech COVID-19 Vaccine. These participants received a second
booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine
or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original
and omicron BA.1) 4.7 to 13.1 months after the first booster dose.
After one month, the immune response against BA.1 of the participants
who received the bivalent vaccine was better than the immune response of
those who had received the monovalent Pfizer-BioNTech COVID-19 Vaccine.
The safety of a single booster dose of the Pfizer-BioNTech COVID-19
Vaccine, Bivalent for individuals 12 years of age and older is based on
safety data from a clinical study which evaluated a booster dose of
Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original
and omicron BA.1), safety data from clinical trials which evaluated
primary and booster vaccination with the monovalent Pfizer-BioNTech
COVID-19 Vaccine, and postmarketing safety data with the monovalent
Pfizer-BioNTech COVID-19 Vaccine.
The safety data accrued with the bivalent vaccine (original and
omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine
are relevant to Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these
vaccines are manufactured using the same process.
The clinical study that evaluated the safety of a booster dose of the
bivalent vaccine (original and omicron BA.1) included approximately 600
participants greater than 55 years of age who had previously received a
2-dose primary series, one booster dose of the monovalent
Pfizer-BioNTech COVID-19 Vaccine, and then 4.7 to 13.1 months later,
received a second booster dose of either the monovalent Pfizer-BioNTech
COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19
vaccine (original and omicron BA.1). Among the study participants who
received the bivalent vaccine, the most commonly reported side effects
included pain, redness and swelling at the injection site, fatigue,
headache, muscle pain, chills, joint pain, and fever.
The fact sheets for both bivalent COVID-19 vaccines for recipients
and caregivers and for healthcare providers include information about
the potential side effects, as well as the risks of myocarditis and
pericarditis.
With today’s authorization, the FDA has also revised the EUA of the
Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to
remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19
vaccines for booster administration for individuals 18 years of age and
older and 12 years of age and older, respectively. These monovalent
vaccines continue to be authorized for use for administration of a
primary series for individuals 6 months of age and older as described in
the letters of authorization. At this time, the Pfizer-BioNTech
COVID-19 Vaccine remains authorized for administration of a single
booster dose for individuals 5 through 11 years of age at least five
months after completing a primary series of the Pfizer-BioNTech COVID-19
Vaccine.
The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.
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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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