Newsman: FDA authorizes 3rd vaccine shot for immunocompromised Americans. People of weaken immunity will be able to get a third shot of either of the mRNA vaccines, Pfizer or Moderna, the U.S. Food and Drug Administration announced late Thursday.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. 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,” acting FDA Commissioner Dr. Janet Woodcock said in a statement Thursday.
“This action is about ensuring our most vulnerable — who may need an additional dose to enhance their own biological responses to the vaccines — are better protected from Covid-19,” CDC Director Dr. Rochelle Walensky said earlier in the day during a White House Covid response team briefing.
A group of independent advisers to the CDC is scheduled to meet Friday to discuss the FDA’s amended emergency use authorization, and offer insights on whether to recommend the agency should make the change, Walensky said.
“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,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”
The FDA said that the additional doses are for “certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” The amended EUAs apply only third doses of the Pfizer and Moderna vaccines.
The FDA’s change does not apply to the general population. Such booster doses would be given only if protection from the vaccines was shown to fall below a certain threshold — though scientists are still working to determine precisely what that threshold is.
“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,” Woodcock continued. “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.”
If the data show in fact that the degree of protection has gone down below a critical level,” Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said Thursday on TODAY, “that’s when you’re going to be hearing about the implementation of boosters” in the general population.
The immunocompromised, however, “never really got a good response to begin with,” he said.
In July, the same panel of CDC advisers urged federal action on extra doses for immunocompromised patients.
Some immunocompromised people even had no immune response to the vaccines — a disappointment considering the high risk they have for getting severely ill from the virus. For example, in one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%.
But Centers for Disease Control and Prevention data shows that a booster shot could increase antibodies in an immunocompromised person by up to 50%.
