Capitol Correspondence - 09.28.21

FDA Approves Booster for People 65+, People at Higher Risk of Severe COVID-19, and People with Increased Occupational Risk; CDC Follows Suit

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On Tuesday, September 22, the U.S. Food and Drug Administration approved the authorization of the Pfizer BioNTech COVID-19 booster for certain individuals, including those who are 65 years of age and older; people 18-64 years of age at high risk of severe COVID-19; and people 18-64 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.

Acting FDA Commissioner Dr. Janet Woodstock stated that the authorization will “allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

Less than a day later, the Centers for Disease Control and Prevention’s vaccine advisory committee endorsed the use of Pfizer and BioNTech’s Covid-19 booster shot, but only for people over 65 and those who may be at risk of developing severe disease—not for those whose occupational exposure placed them at higher risk.

However, later that day, CDC Director Dr. Rochelle Walensky broadened the recommendations made by the advisory panel. The CDC stated that people aged 65 years and older, residents in long-term care settings, and 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 completing their Pfizer-BioNTech primary series and that other groups of people, including those who have increased occupational exposure, may receive a booster shot based on their individual risk and benefit.

As a result, the CDC’s official guidance specifies that two groups should get a booster shot if they initially received the Pfizer vaccine at least six months ago, and if they:

  • Are individuals 65 years of age or older, OR
  • Are 50 years of age or older and at high risk of severe illness from COVID-19.

Additionally, the CDC guidelines stipulate that two groups may get a booster shot if they had their second Pfizer shot at least six months ago and they:

  • Are 18 and older and at high risk of severe illness from COVID-19, OR
  • Are 18 older and work in an occupation that puts them at higher risk than the general population for exposure to the SARS-CoV-2 virus.