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FDA Rules on COVID Booster Shot - 09/17/2021

FDA Rules on COVID Booster Shot - 09/17/2021

In a meeting last week, a panel of advisors to the Food and Drug Administration recommended against widespread approval of a Pfizer-BioNTech COVID-19 booster dose. The proposed booster dose would be given about 6 months after the primary 2-dose series to those ages 16 years and older. This panel of experts voted 16-2 against widespread approval, surprising many who expected approval to occur. However, the panel did vote 18-0 in support of the FDA approving a booster dose for those 65 years and older or at high risk for severe disease. The FDA also polled the panel members for advice on other populations that may be eligible for a booster dose. Although not an official vote, panel members were reported to unanimously support approval of a Pfizer booster dose for those with high occupational exposure risk, such as healthcare workers.

Just today, September 24, the CDC director overruled the CDC's own Advisory Committee on Immunization Practices concerning these recommendations, putting the CDC's guidance into alignment with the FDA's guidance. Per the CDC interim guidance, the following patient populations should or may receive a Pfizer-BioNTech booster vaccine at least 6 months after their primary vaccine series:

  • Should: people aged 65 years and older, nursing home/long-term care residents, people aged 50 through 64 years with underlying medical complications (eg, cancer, immunocompromised state, diabetes, heart conditions, etc)
  • May: people aged 18 through 49 years with underlying medical complications (same as "should" category), people aged 18 through 64 with increased risk for COVID-19 exposure/transmission based on occupational setting
    • For those falling in the "may" category, decision to receive a booster should be based on individual risk/benefit profile

As more data become available on long-term efficacy of the Moderna and J&J/Janssen vaccines, recommendations regarding those specific vaccines will be addressed.

The high infectivity of the Delta variant and evidence that protection from the Pfizer vaccine and immunity to COVID-19 decreases over time were 2 of the factors supporting use of a booster dose. However, data continues to show that those vaccinated with the 2-dose series are protected from severe disease, hospitalization, and death in the US. An analysis published on September 17 in the CDC's Morbidity and Mortality Weekly Report found that the Pfizer vaccine's protection against hospitalization with COVID-19 decreased from 91% to 77% after more than 120 days following complete vaccination.

This virus is a moving target. Sound research with systematic analyses of the data is most important to inform these important decisions affecting billions of people and impacting the trust of the public, both here and abroad.


Filed under: Health Policy and Trends, Infectious Diseases, Preventive Medicine, Public Health

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