FDA, CDC Take Steps to Expand Use of COVID-19 Vaccines

Early this week, the U.S. Food and Drug Administration (FDA) took steps to expand the use of the Pfizer-BioNTech COVID-19 Vaccine among key populations throughout the country. The FDA amended the emergency use authorization (EUA) for the vaccine to:

  • Expand the use of a single booster dose to include use in individuals ages 12-15
  • Shorten the time between the completion of primary vaccination series and a booster dose to at least five months
  • Allow for a third primary series dose for certain immunocompromised children ages 5-11

Following the actions by the FDA, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened to review the latest available data and update its vaccine recommendations. The ACIP voted 13-1 to recommend that the CDC support booster doses for 12–15-year-olds at least five months after their primary series.

CDC Director Dr. Rochelle Walensky on Wednesday endorsed the ACIP’s recommendation, paving the way for adolescents aged 12 to 17 years old to receive a booster dose against COVID-19. The Western States Scientific Safety Review Workgroup similarly recommended booster eligibility for adolescents ages 12-15 in California. The Office of Governor Gavin Newsom issued a statement following the workgroup’s decision. California Health and Human Services Secretary Dr. Mark Ghaly and California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón also issued a statement following the group’s recommendation and urged residents to receive their vaccine when eligible.  

The CDC additionally updated its recommendations to align with the FDA’s shortened Pfizer booster timeframe from six months to five months and allow for at third primary series dose for certain immunocompromised children.

Today, the FDA took a similar step for the Moderna COVID-19 booster dose, updating the emergency use authorization (EUA) to shorten the timeframe between a primary series and booster dose from six months to five months. The CDC is anticipated to soon update its recommendations for the Moderna vaccine to align with the FDA.