FDA targets early September for COVID-19 booster strategy

The Food and Drug Administration (FDA) is anticipating having a national COVID-19 booster strategy ready by early September, several news outlets have reported.

The COVID-19 strategy would pertain to all vaccinated Americans and would lay out which groups of Americans should get their third shot and when. 

The Wall Street Journal, which first reported the news, said that the Biden administration has pushed the agency to roll out their strategy more quickly because certain individuals, including those who are immunocompromised and those age 65 years and older, could need booster shots as early as late August.

A White House official told CNN that a decision is expected sooner than early September from the FDA on when immunocompromised Americans should receive the third shot. 

“The FDA, along with the CDC [Centers for Disease Control and Prevention] and NIH [National Institutes of Health], are evaluating potential solutions to questions on the use of booster doses of COVID-19 vaccines,” a FDA spokesperson told The Hill in a statement. “The agencies are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”

“Regarding immunocompromised individuals, the FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals. The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future,” the spokesperson continued. 

The reporting follows comments that President Biden’s chief medical adviser Anthony Fauci made yesterday where he said that the administration was working to give booster shots to immunocompromised people “as quickly as possible.”

“It is extremely important for us to move to get those individuals their boosters, and we are now working on that and will make that be implemented as quickly as possible, because for us and for the individuals involved it is a very high priority,” Fauci said at a White House press briefing on Thursday.

Though the Biden administration has said that booster shots are not needed yet, Fauci’s comments and the FDA’s expected rollout of a national booster shot strategy underscore how the increasing spread of delta variant in unvaccinated communities and a plateau of vaccinations in the U.S. have complicated efforts to contain the coronavirus in the U.S.

According to data from the Centers for Disease Control and Prevention, 70 percent of Americans age 18 and older have received at least one dose and 61 percent are fully vaccinated.

The Hill has reached out to the White House for comment.