The Food and Drug Administration (FDA) is expected to announce that it will authorize COVID-19 booster shots for immunocompromised individuals, according to multiple reports.

The booster would reportedly be a third shot of the two-dose Pfizer and Moderna COVID-19 vaccines.


What You Need To Know

  • The Food and Drug Administration will reportedly release updated emergency use authorizations for both the Pfizer and Moderna COVID-19 vaccines to approve a third booster shot in immunocompromised individuals

  • A spokesperson for the FDA told Spectrum News the agency is “closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals"

  • Several studies are looking at booster shots for certain at-risk groups — people with weakened immune systems, adults over 60 years old and health care workers

  • An untold number of Americans have managed to get COVID-19 booster shots by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated

The news was first reported by NBC News and confirmed by CNN. NBC News reports that the FDA’s update is expected to be formally announced on Thursday. 

A spokesperson for the FDA told Spectrum News the agency is “closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals,” adding that both the FDA and CDC are “evaluating potential options on this issue, and will share information in the near future.”

In an interview with CBS News on Thursday, Dr. Anthony Fauci said that such a decision is "imminent" on giving vaccines to the immunocompromised, and it is "likely" that all Americans will require booster shots against COVID-19 "in the future."

"It’s likely that that will happen at some time in the future,” Fauci said. “We’re already starting to see indications in some sectors about a diminution over time, that’s durability."

"We don't feel at this particular point that, apart from the immune compromised, we don't feel we need to give boosters right now," Dr. Fauci said, but noted that they are following data "in real time" and guidance could change.

Fauci said that "it is preferable" that people stick with the same brand when it comes to booster shots, and the FDA will provide guidance when the time comes.

"Inevitably there will be a time when we’ll have to get boosts," Dr. Fauci said on NBC's "TODAY Show" on Thursday, because "no vaccine, at least not within this category, is going to have an indefinite amount of protection."

People have compromised immune systems for a variety of reasons, including organ transplants, cancer or other conditions. Any authorization for an additional booster shot would come from the Federal Drug Administration.

Several studies are looking at booster shots for certain at-risk groups — people with weakened immune systems, adults over 60 years old and health care workers. 

But the verdict is still out on whether the general population might need them, said Dr. Michelle Barron, senior medical director for infection prevention at UCHealth, a not-for-profit health care system based in Aurora, Colorado. She said the best data in favor of possible boosters is for people whose immune systems are compromised.

The Advisory Committee on Immunization Practices (ACIP) is set to hold one of its thrice-annual meetings to discuss scientific data and review recommendations for vaccines on Aug. 13 in Atlanta, Georgia. One of the meeting’s first agenda items reads: “Updates on additional doses in immunocompromised individuals.” 

Just over a month ago, the FDA and CDC issued a joint statement saying “Americans who have been fully vaccinated do not need a booster shot at this time,” adding that the agencies were in the midst of a “rigorous” review process to determine when boosters might be necessary, and for whom. 

Already, an untold number of Americans have managed to get COVID-19 booster shots by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated.

Health care providers in the U.S. have reported more than 900 instances of people getting a third dose of COVID-19 vaccines in a database run by the CDC, an Associated Press review of the system’s data found. Because reporting is voluntary, the full extent of people who have received third doses is unknown. It’s also unknown if all of those people were actively trying to get a third dose as a booster.

This is a developing story. Check back later for further updates.

The Associated Press contributed to this report.