The U.S. Food and Drug Administration (FDA) has finally amended the Emergency Use Authorizations (EUA) for the third dose of Pfizer-BioNTech and Moderna COVID-19 vaccines for immunocompromised people, according to NBC News.
The agency’s approval is specific to patients who have failed to develop an adequate immune response against the coronavirus, even after being fully vaccinated.
Experts say the additional dose in immunocompromised patients will offer the same level of protection that is seen in people without weakened immune systems.
The Centers for Disease Control and Prevention (CDC) says an estimated 2.7% of American adults are immunocompromised, which means they are either organ transplant recipients or have certain diseases such as cancer and HIV.
FDA Commissioner Dr. Janet Woodcock said in a statement, “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.”
The agency said 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.”
Please note that the current amended EUA applies only for the third dose of the Pfizer-BioNTech and Moderna vaccines.
CDC Director Dr. Rochelle Walensky said, “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.”
However, the agency’s approval does not apply to people without a weakened immune system. A booster dose 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, according to NBC News.
Dr. Anthony Fauci, the nation’s top infectious disease expert, said, “If the data show in fact that the degree of protection has gone down below a critical level, that’s when you’re going to be hearing about the implementation of boosters” in the general population.
However, he explained that the immunocompromised, “never really got a good response to begin with.”
A study, published Wednesday in the New England Journal of Medicine, found that a third dose of the Moderna vaccine increases antibody levels in organ transplant recipients.
Dr. Dorry Segev of Johns Hopkins University said, “Even if patients do not develop detectable levels of antibody with the first two doses, it doesn’t mean the shots aren’t working on some level.”
He said it is likely that the first two shots are “already priming the immune system,” adding, “all the immune system needs is one more exposure to the vaccine, one more exposure to the components of the spike protein, and then blossom into an immune response.”
However, it remains unclear how robust the response would be after administering the third dose.
Another study from Dr. Segev and his colleagues highlighted just how vulnerable organ transplant recipients are, even after being fully vaccinated.
The study, published last month in the journal Transplantation, looked at more than 18,000 fully vaccinated organ transplant recipients. The researchers found that they were 82 times more likely to get a breakthrough infection and 485 times more likely to have that infection lead to hospitalization or death, according to NBC News.
