The US Food and Drug Administration (FDA) has amended its emergency use authorizations for Pfizer and Moderna bivalent vaccines, allowing certain individuals to receive additional doses before this fall’s vaccination campaigns. The changes include increased eligibility for adults 65+, individuals with certain degrees of immunocompromise, unvaccinated individuals, and children ages 6 months through 5 years.
The U.S. Food and Drug Administration (FDA) has amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines, allowing certain individuals to receive additional doses before this fall’s vaccination campaigns.
Changes in Eligibility Criteria
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Adults ages 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months following their first dose.
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Most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second dose at least two months later. Additional doses may be administered at the discretion of their healthcare provider.
New Recommendations for Unvaccinated Individuals
The FDA has also simplified its recommendation for unvaccinated individuals, stating that most unvaccinated individuals may now receive a single dose of a bivalent vaccine, rather than multiple doses of the original single-strain vaccines. This change reflects the agency’s recognition that most Americans now have some immunity against Covid-19, either from vaccination or infection.
Additional Changes
The FDA has made additional changes to its emergency use authorizations, including:
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Children ages 6 months through 5 years who have not yet been vaccinated may now receive a two-dose series of the Moderna bivalent vaccine as their primary series.
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Children ages 6 months through 4 years who got started on their monovalent vaccines can now get a dose of a bivalent vaccine, but the number of doses they qualify for will depend on the number of doses they’ve already had and what kind of vaccine they got.
Background
Expert Reaction
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital, has been calling on the FDA to increase access to the bivalent boosters for those who want them. He says that for the most part, today’s guidance from the agency makes sense, but questions why the 65-year age cutoff was chosen.
Sources
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CNN Health
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FDA news release
