Following days of lengthy debates, 3rd doses of the Pfizer-BioNTech COVID-19 vaccine or “boosters” can now be officially administered to certain individuals in the U.S., as endorsed by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), specifically for older individuals and other vulnerable populations at high risk of exposure to the virus.
The FDA has amended the emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to allow for boosters of older individuals and other vulnerable populations at high risk of exposure to the virus. The Pfizer COVID-19 vaccine is currently the only COVID-19 vaccine with full approval from the FDA for individuals 16 years of age and older as well as has EUA for individuals 12 through 15 years old and now for boosters for certain groups.
The FDA’s decision was based on its 18-member Vaccines and Related Biological Products Advisory Committee who first considered Pfizer's application for full approval to make boosters available to those 16 and older, but voted overwhelmingly against that proposition 16-2. The advisory committee then unanimously approved emergency authorization for boosters of the Pfizer COVID-19 vaccine for:
- people older than 65
- individuals 18 through 64 years old at a high risk for severe illness if infected with the virus (which has previously included people with diabetes, heart disease, obesity and other so-called comorbidities)
- individuals 18 through 64 years old at a high risk of institutional or occupational exposure to the virus
The FDA’s advisory committee members would like to review more data before authorizing boosters for the general population. Data presented showed that, while vaccine effectiveness against infection appears to be waning, effectiveness against severe illness and hospitalization in the U.S. remains high. Pfizer says the evidence shows boosters are needed to restore waning protection and reduce the spread of Delta and other emerging variants of the COVID-19 virus.
The CDC’s Advisory Committee on Immunizations Practices (ACIP) met to discuss Pfizer COVID-19 vaccine boosters and similar to the FDA’s authorization endorsed vaccine boosters for people older than 65, long-term care facility residents and people 50 and older with underlying conditions. However, the ACIP voted against recommending boosters for those individuals at a high risk of occupational exposure to the virus and thereby rejecting part of the FDA’s EUA. The CDC Director, Dr. Rochelle Walensky, has since announced that in addition to the ACIP’s recommendations the CDC’s recommendations will align with the FDA’s booster authorization and include adults at a high risk of institutional or occupational exposure to the virus.
The FDA and CDC along with its advisory committees will continue to consider use of COVID-19 vaccines as additional data is generated and reviewed as well as additional approvals or authorizations for emergency use are requested by COVID-19 vaccine manufacturers.
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