The Medical Letter on Drugs and Therapeutics
COVID-19 Update: FDA Expands Bivalent Vaccine Use, Revises Vaccination Schedules
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Med Lett Drugs Ther. 2023 May 1;65(5063):1   doi:10.58347/tml.2023.5063a

The FDA has amended its Emergency Use Authorizations (EUAs) for the bivalent mRNA COVID-19 vaccines (original and Omicron BA.4/5 strains) manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit their use for all doses administered to persons ≥6 months old. The monovalent Pfizer and Moderna vaccines are no longer authorized for use in the US.1

All persons ≥6 months old who completed a primary series with the Pfizer or Moderna monovalent vaccine may now receive a single dose of bivalent vaccine; an additional bivalent dose can generally be given to persons ≥65 years old and to those with significant immunocompromise. For unvaccinated persons ≥5 years old (Pfizer) or ≥6 years old (Moderna), a single bivalent dose is now recommended for primary immunization; multiple doses are recommended for younger children. The new recommendations for the Pfizer and Moderna vaccines are summarized in Table 1.1-3

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