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FDA Expands EUA for Moderna and Pfizer COVID-19 Boosters
The boosters are now authorized for all people 18 years of age and older.
The FDA has extended both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all people 18 years of age and older.
Previously, a single booster dose of both vaccines was authorized for people 65 years of age and older and those at risk of severe COVID-19 or those with occupational exposure.
The boosters are now authorized for those after at least six months after completion of the primary series for the Moderna or BioNTech vaccines or at least two months after completion with the Janssen vaccine.
The EUA for a single booster is based on the FDA’s analysis of immune response data. For the Moderna booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it with the immune responses of 1,055 study participants after completing their two-dose series.
For the Pfizer-BioNTech booster dose, the FDA analyzed the immune response data from about 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the virus one month after a booster dose of the vaccine when compared with the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
Related: Pfizer Submits EUA for COVID-19 Vaccine Booster for All Adults
Both Pfizer and Moderna are conducting post-authorization studies to assess serious risks of myocarditis and pericarditis
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