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FDA and CDC Authorize Booster Doses for Targeted Population Groups

On September 22, 2021, the Food and Drug Administration (FDA) updated the Pfizer/BioNtech COVID-19 vaccine emergency use authorization (EUA) to allow for booster doses for select patient groups, including those who are over 65 or at increased risk of severe COVID-19 infection.

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The FDA also authorized booster doses of COVID-19 vaccine for individuals at risk from institutional or occupational exposure to SARS-CoV-2.  However, on September 23, the Advisory Committee on Immunization Practices (ACIP)  voted 6-9 against this recommendation, notably excluding healthcare workers from the inclusion criteria.  The Centers for Disease Control and Prevention (CDC)  overruled the recommendations from the ACIP on September 24 and released the following official guidance on who should and who may receive a booster dose of vaccine:

  • People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

  • People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.

  • People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

  • People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.