FDA backpedals on covid boosters, says not to take them
FDA Recommends People Only Take One mRNA COVID Vaccine, No More Boosters
by Kyle Becker
The U.S. Food and Drug Administration (FDA) has revised the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines to simplify the vaccination schedule for most individuals.
The updated EUAs authorize the use of the current bivalent vaccines, covering the original strain and the omicron BA.4/BA.5 strains, for all doses given to individuals aged 6 months and older, including additional doses for certain populations. However, the monovalent versions of the Moderna and Pfizer-BioNTech vaccines are no longer authorized for use in the United States.
Key Points to Note:
- Individuals previously vaccinated with a monovalent COVID-19 vaccine who haven’t received a bivalent vaccine may receive a single dose of the bivalent vaccine, depending on their age.
- Individuals who have already received a single dose of the bivalent vaccine are currently not eligible for an additional dose. The FDA will make decisions regarding future vaccinations after receiving recommendations from an FDA advisory committee meeting in June to discuss the fall strain composition.
- Individuals aged 65 and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months after their initial bivalent dose.
- Most individuals with specific types of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose at least 2 months after a dose of the bivalent vaccine. Additional doses can be administered based on the discretion and guidance of healthcare providers. However, eligibility for additional doses for immunocompromised individuals aged 6 months to 4 years will depend on the previously received vaccine.
- Unvaccinated individuals can receive a single dose of a bivalent vaccine instead of multiple doses of the original monovalent mRNA vaccines.
- Children aged 6 months to 5 years 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 old can receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children aged 6 months to 5 years who have received one, two, or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, depending on the vaccine and their vaccination history.
“Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines,” the FDA said.
“Most Americans who have already received a bivalent booster will not be eligible for another dose for now,” the agency added.
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