COVID-19, Federal | October 22, 2021

FDA, CDC Greenlight Moderna, Johnson & Johnson COVID-19 Boosters for Certain Populations

Following last week’s unanimous recommendation from the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) relative to COVID-19 booster vaccines, both the FDA and the U.S. Centers for Disease Control and Prevention (CDC) this week officially approved the use of booster doses for specified populations.

On Wednesday, the FDA formally accepted the VRBPAC recommendations by amended the emergency use authorizations (EUAs) for both the Moderna and Johnson & Johnson COVID-19 vaccines. The FDA’s authorizations include:

  • A single booster dose of the Moderna COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals:
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • A single booster dose of the Janssen (Johnson & Johnson) COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older
  • The use of each of the available COVID-19 vaccines as a heterologous (“mix-and-match”) booster dose in eligible individuals following the completion of primary vaccination with a different available COVID-19 vaccine
  • To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after the completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

On Thursday, the CDC Advisory Committee on Immunization Practices (ACIP) similarly took steps to recommend a booster shot of the COVID-19 vaccine in certain populations. CDC Director Dr. Rochelle Walensky endorsed the ACIP recommendations, enabling specified Americans to receive a COVID-19 vaccine booster, including a “mix-and-match” booster dose.

Additional information from the FDA is available here. Additional information from the CDC is available here.

UPDATE: On October 22, 2021, the Western States Scientific Safety Review Workgroup completed its review of data associated with the above boosters and aligned its recommendations with the FDA and CDC. More information is available here.