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FDA Approves and CDC Recommends Single Bivalent mRNA Vaccine

Last week, the Food and Drug Administration (FDA) approved and the Centers for Disease Control and Prevention (CDC) issued recommendations for a bivalent mRNA COVID-19 vaccine, replacing the monovalent mRNA vaccine (Moderna and Pfizer), which is now no longer authorized for use in the U.S.

The CDC's Interim Clinical Recommendations for Bivalent COVID-19 Vaccine, posted April 22, 2023, can be found hereThis page also provides a detailed vaccine schedule for various populations, ages, and health statuses. Providers should note that Department of Health (DOH) guidance on these recommendations has not yet been issued. Providers should offer this new vaccine to both staff and residents in accordance with the current State vaccine mandate provided in regulation and set forth in guidance.

Revision of the mRNA COVID-19 vaccination schedule is as follows:

  • At the time of initial vaccination, depending on vaccine product, children ages 6 months to 4 years are recommended to receive two or three bivalent mRNA vaccine doses; children age 5 years are recommended to receive one or two bivalent mRNA vaccine doses.
  • People ages 6 years and older who are unvaccinated or previously received only monovalent vaccine doses are recommended to receive one bivalent mRNA vaccine dose.
  • People ages 65 years and older may receive one additional bivalent mRNA vaccine dose.

People ages 65 years and older have the option to receive one additional bivalent mRNA vaccine dose at least four months after the first dose of a bivalent mRNA vaccine.

For information for individuals who are moderately or severely immunocompromised, click here.

Vaccination After COVID-19 Infection

COVID-19 vaccination is recommended for everyone ages 6 months and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection, including people with prolonged post-COVID-19 symptoms.

People with known current SARS-CoV-2 infection should defer any COVID-19 vaccination at least until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.

People who recently had SARS-CoV-2 infection may consider delaying a COVID-19 vaccine dose by three months from symptom onset or positive test (if infection was asymptomatic).

Interchangeability of Vaccines

Members asked about individuals who have received only the first monovalent mRNA vaccine of a two-dose series. Those individuals may move to the single bivalent at least eight weeks after the monovalent dose. More details are available here.

  • People ages 6 years and older who previously received one or more doses of a monovalent mRNA vaccine are authorized to receive either the bivalent Moderna or bivalent Pfizer-BioNTech COVID-19 vaccine.

The COVID-19 bivalent vaccine-specific FDA fact sheets and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures.

Contact: Meg Everett, meverett@leadingageny.org, 518-867-8871