FDA and CDC Update COVID-19 Vaccine Recommendations

This article first appeared on our sister brand, Contagionlive.com.

Following the US Food and Drug Administration (FDA) authorization on April 18, 2023, the US Centers for Disease Control and Prevention (CDC) has significantly changed its COVID-19 vaccine recommendations.

The most significant update is that the FDA and CDC now recommend that the Moderna and Pfizer-BioNTech mRNA bivalent mRNA vaccines (original and Omicron BA.4/BA.5 strains) be used for all future vaccinations in the US. This means both agencies are officially moving away from the initial, monovalent COVID-19 vaccines.

The CDC now recommends:

• Adults 65 years and older receive an additional dose of the Moderna or Pfizer-BioNTech COVID-19 bivalent mRNA vaccine.

• Everyone 6 years and older receive an updated bivalent mRNA vaccine (unless they have already).

• Individuals unvaccinated against COVID-19 receive a single dose of an authorized bivalent vaccine rather than multiple doses of original monovalent mRNA vaccines to complete a primary series.

Immunocompromised individuals may be eligible to receive additional doses of a bivalent vaccine, even if they have already. Individuals with comorbidities or otherwise immunocompromised should consult a health care provider to determine their needs and ensure they can mount an adequate immune response to vaccination.

The new regulations were announced tonight, April 19, after the CDC’s Advisory Committee on Immunization Practices (ACIP) met to discuss these changes to their COVID-19 vaccine recommendation.

Most individuals who have already received a single dose of the bivalent Pfizer-BioNTech or Moderna booster are only eligible for another dose if they are immunocompromised or 65 years and older. The FDA will likely announce future vaccination recommendations after determining fall’s vaccine strain composition in their June advisory meeting.

Alternative options are still available for individuals unable to receive an updated bivalent COVID-19 vaccine. Today's decision did not affect the CDC’s recommendation of the (monovalent) Novavax or Johnson & Johnson’s Janssen COVID-19 vaccines.

Keep up with COVID-19 on Infection Control Today^®.