FDA considering second COVID-19 booster in coming months

Food and Drug Administration (FDA) officials are “very carefully” considering second booster doses of the mRNA COVID-19 vaccines, according to The Wall Street Journal.

FDA spokesperson Alison Hunt confirmed to CNN that the FDA “is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster doses.”

Hunt also said that there is still much uncertainty, but the FDA is evaluating whether another booster dose will be needed when the country moves into the fall of 2022, which would coincide with the typical administration of annual flu shots, CNN noted.

“As more data become available about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Hunt wrote to CNN. “Any determination that additional booster doses are needed will be based on data available to the agency.”

If the FDA approves another booster dose, it would then face approval by the Centers for Disease Control and Prevention (CDC). 

Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases (NIAID), said the “potential future requirement” for an additional booster is being “very carefully monitored in real time, and recommendations, if needed, will be updated according to the data as it evolves.”

Fauci also said that he believes the timing of when the second booster would be administered is critical and that it “doesn’t make much sense” to administer the fourth dose now as omicron begins to fade.

Fauci suggested that it would be best to administer a second booster, if needed, in the fall or winter, when a new variant is more likely to emerge, CNN reports.

Both Pfizer-BioNTech and Moderna are currently developing omicron-specific vaccines, and both companies believe a fourth dose will eventually be necessary to keep protection levels high.

However, the CEO of BioNTech said Thursday that stalls in data evaluation have lead to a weeks-long delay in the development, as it still unclear whether or not these altered vaccines will be needed. It is also unclear whether or not a potential fourth dose approved by the FDA would be tailored to a new variant use the same formulation as previous doses. 

Israel was the first country to approve a second booster shot for certain citizens in December, while Sweden approved another booster for residents over the age of 80 on Monday.

Immunocompromised people in the U.S. have been eligible for a second booster shot since October, according to CDC guidelines.