FDA, CDC Act on Pfizer COVID-19 Boosters for Certain Populations
Following last week’s recommendation by the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) to recommend COVID-19 vaccine boosters for older adults and high-risk groups, the FDA and the CDC took similar steps this week to authorize and recommend the boosters for certain populations.
On Wednesday, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose to be administered at least six months after completion of the primary series in:
- Individuals 65 years of age and older
- Individuals 18 through 64 years of age at high risk of severe COVID-19
- Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19
The booster dose authorized by the FDA applies only to the Pfizer-BioNTech COVID-19 vaccine.
On Thursday, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend a booster dose of the Pfizer-BioNTech COVID-19 vaccine in certain populations. Today, CDC Director Dr. Rochelle Walensky endorsed the ACIP’s recommendations. The CDC now recommends:
- People 65 years and older and residents in long-term care settings should receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series
- People aged 50-64 years with underlying medical conditions should receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series
- People aged 18-49 with underlying medical conditions may receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks
- People aged 18-64 years who are at an increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks
According to the CDC, many of the people who are now eligible to receive a booster dose received their initial vaccine early in the vaccination program and will benefit from additional protection.
Following the FDA’s authorization for booster doses, California Health and Human Services (CHHS) Agency Secretary Dr. Mark Ghaly and California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón issued a statement reassuring residents of the safety and efficacy of the COVID-19 vaccines and expressing support for the administration of booster doses among certain populations. The state officials also indicated the Western States Scientific Safety Review Workgroup would be assessing available data, the FDA’s authorization, and the CDC’s recommendations today.
The Western States Workgroup this afternoon issued a statement on the Pfizer-BioNTech COVID-19 vaccine booster following their meeting today. The Workgroup concurred with the CDC’s recommendations and aligned their guidance with the federal government’s.
The Workgroup additionally strongly endorsed “CDC’s recognition that long-standing systemic health and social inequities have increased the risk of severe illness from COVID-19.” Therefore, the Workgroup recommends that social determinants of vulnerability be included in the assessment of conditions that qualify individuals for booster doses. The Workgroup also called on the FDA and CDC to quickly identify solutions to sustain the protection of the most vulnerable individuals who received Moderna or Johnson & Johnson (Janssen) COVID-19 vaccines.
Additional information from the Office of Governor Gavin Newsom is available here.