The U.S. Food and Drug Administration said it has amended the emergency use authorizations or EUAs of COVID-19 bivalent mRNA vaccines of ModernaTX Inc. and Pfizer-BioNTech to simplify the vaccination schedule for most individuals.
With the changes, the current bivalent vaccines, for original and omicron BA.4/BA.5 strains, can 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.
As per the authorized changes to the vaccination schedule, a single dose of a bivalent vaccine can be given to most individuals, who were previously vaccinated with a monovalent COVID-19 vaccine and not yet received a dose of a bivalent vaccine.
Further, 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.
Those 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. 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.
Meanwhile, most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose.
For children 6 months through 5 years of age, who are unvaccinated, may receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine. 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.
Further, 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.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “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. 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.”
According to the agency, the available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.
The FDA said it intends to make decisions about future vaccination after receiving recommendations on the strain composition of the COVID-19 vaccines for fall of 2023 at an FDA advisory committee in June.
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