FDA authorizes third vaccine dose for immunocompromised people

The Food and Drug Administration (FDA) on Thursday authorized a third dose of COVID-19 for certain people with compromised immune systems, a narrow move into the realm of booster doses amid a growing debate over their use.

The move will allow a third dose of both the Pfizer-BioNTech and Moderna vaccines, and applies to certain immunocompromised people, including those with organ transplants and those “diagnosed with conditions that are considered to have an equivalent level of immunocompromise,” the FDA said.

The agency emphasized that the general public does not need a third dose at the moment.

Slides presented at a Centers for Disease Control and Prevention advisory meeting last week said about 2.7 percent of U.S. adults are immunocompromised.

Federal health officials officials emphasized the group is small.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease,” said acting FDA Commissioner Janet Woodcock. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.”

But health officials have left the door open to third doses, stating that they may be needed eventually.

Anthony Fauci, the government’s top infectious disease expert, earlier Thursday said “inevitably” there will be a time when the wider public needs a booster, though now is not the time.

“Inevitably, there will be a time when we’ll have to give boosts,” Fauci said on NBC. “What we’re doing, literally, on a weekly and monthly basis is following cohorts of patients to determine if, when and whom should get it.”

A broader issuance of booster doses would be controversial given that many people around the world, including health care workers in some countries, are still waiting for their first dose.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Woodcock said.

“As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”