The Food and Drug Administration authorized extra doses of a COVID-19 vaccine for people with fragile immune systems who were not sufficiently protected after the first vaccination regimen.
“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,” FDA Commissioner Janet Woodcock said.
OVER 1 MILLION PEOPLE HAVE OBTAINED COVID-19 BOOSTER SHOTS WITHOUT FDA APPROVAL
The agency revised the Emergency Use Authorization guidelines for the Pfizer-BioNTech and Moderna vaccines to allow for the so-called booster doses to be given to people who have received an organ transplant, are undergoing cancer treatments, and other medical conditions that weaken the person’s natural immune response to infections.
“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.”
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The FDA’s updated guidelines come less than a month after a panel of vaccine experts at the Centers for Disease Control and Prevention debated the necessity of the boosters for the relatively small portion of the population (2.7%) with compromised immune systems. While the panelists did not issue an endorsement for the boosters, they cited a growing body of evidence showing that immunocompromised patients would benefit from the extra shot.
The panel of experts met again on Friday and voted unanimously to support the new guidelines allowing immunocompromised patients to get the boosters. CDC Director Rochelle Walensky gave the final go-ahead within hours to begin distributing the boosters.
“At a time when the Delta variant is surging, an additional vaccine dose for some people with weakened immune systems could help prevent serious and possibly life-threatening COVID-19 cases within this population,” Walensky wrote.
To date, more than 71% of U.S. adults have received at least one shot, and 61% have been fully vaccinated.
