The FDA is planning to amend the emergency use authorization orders for the Pfizer and Moderna COVID vaccines to allow a third dose for certain immunocompromised people who may not have had adequate protection from just two doses.
The FDA is planning to amend the emergency use authorization orders for the Pfizer and Moderna COVID-19 vaccines on Thursday to allow a third dose for certain immunocompromised people who may not have had adequate protection from just two doses, a source confirmed to CBS News.
The FDA’s amendment, long telegraphed by White House and federal officials, is a key step towards allowing some immunocompromised Americans to bolster their immunity to COVID-19.
Technically, vaccine providers still cannot administer additional doses to any Americans under the current federal agreement governing the shots. Even after the FDA amends its emergency use authorization, vaccinators must wait for the CDC director and the agency’s advisers to formally recommend the move. The CDC’s independent panel of vaccine advisers is scheduled to meet Friday morning to discuss the issue.
An FDA spokesperson declined to comment on the timing of the decision, saying that the agency is “evaluating potential options on this issue, and will share information in the near future.”
A small share of American adults, less than 3%, are estimated to have compromised immune systems and often need additional doses of other vaccines to build sufficient protection against viruses.
Dr. Anthony Fauci, the president’s chief medical adviser, recently told CNN that he believes some immunocompromised people should get a booster “very soon.”
“When you look at immune compromised people, namely those with cancers, those on chemotherapy for a variety of diseases, those who have immune depression of some sort of another, they likely never got a good immune response to begin,” Fauci said.
“We think they should get that additional boost sooner rather than later. Very soon,” he added.
An array of drug companies and researchers, including the National Institutes of Health, are also launching studies to examine third doses in immunocompromised people.
The CDC recently acknowledged that some Americans had resorted to seeking out additional doses ahead of federal authorities allowing it.
“We can discern between people who have gotten second and third shots. We are trying hard to encourage people to report on the safety side if people have taken the initiative to get their third shot — again, not recommended — but we have the capacity and are looking at those data right now,” CDC Director Rochelle Walensky said earlier this month.
While federal officials have long promised that they planned to accelerate regulatory approval for immunocompromised Americans to receive a third shot, it could still be months until Americans who aren’t immunocompromised can seek additional doses of the vaccine.
A growing body of evidence suggests at least some Americans may eventually need at least one additional shot to boost their immunity to the virus, though federal health officials have insisted the current batch of vaccines currently appear to remain effective even against the Delta variant.
“I suspect, again, by sometime in September, we’ll be able to make some more coherent statement about what the recommendation will be here,” Dr. Peter Marks, a top FDA official overseeing the vaccine approvals, said last month.
Max Bayer contributed to this report.