FDA Advisers Unanimously Recommend Pfizer-BioNTech Booster Shot for Older Adults and Vulnerable Groups

Strategic Insights -

Friday's meeting of the FDA's advisory committee saw a consensus on recommending a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 65 years and older and those at risk of severe illness, paving the way for a decision from the agency expected by next week. The committee's deliberations revealed a range of opinions among top medical experts on the necessity, timing, and scope of booster shots, including concerns about the availability of safety data for younger adults.

Key Takeaways:

  • The FDA advisory committee voted unanimously to recommend a booster shot of the Pfizer-BioNTech vaccine for people 65 years and older and those at risk of severe illness, following Pfizer's recommendation.
  • The panel rejected a broadly available booster, with many members citing concerns about the lack of robust safety data for younger adults.
  • The debate highlighted divisions among experts on whether boosters are necessary and for whom, with some advocating for a narrower approach.
  • The FDA official overseeing coronavirus vaccines, Peter Marks, indicated that the final decision could encompass people who are at higher risk of infection because of their professions, such as health-care workers and front-line employees.
  • A Centers for Disease Control and Prevention advisory committee is slated to meet next week to recommend how a third shot should be used.

Statistics:

  • 88% protection against hospitalization for adults 75 and older (unpublished CDC data through July)
  • 11-fold lower risk of contracting an infection for people 60 and older who received a booster shot compared to those who did not (study published in the New England Journal of Medicine)
  • Cases doubling every 10 days in Israel, with a huge uptick in infections and severe cases among fully vaccinated individuals (study presented by Sharon Alroy-Preis)

Sources:

  • Carolyn Y. Johnson; Laurie McGinley; Joel Achenbach (The Washington Post)
  • Sharon Alroy-Preis (Israel's Ministry of Health)
  • William C. Gruber (Pfizer)
  • Anthony S. Fauci (National Institute of Allergy and Infectious Diseases)