As U.S. regulators authorize an extra dose of the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems, who is included and when can they get their booster dose?
The late-night announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
The announcement comes as the extra-contagious delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.
Importantly, the FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It’s not an opening for booster doses for the general population.
The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA's acting commissioner, said in a statement.
The authorization from the FDA applies only to "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."
It’s harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.
The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
"There has been a number of studies looking at how well does the vaccine perform in people with different underlying conditions? And the vaccine performs beautifully in the huge majority of Americans, but in people who are severely immunocompromised, for example after an organ transplant or people who are undergoing chemotherapy or who are on severe immune suppressing medications - not surprisingly, the goal of those medications and treatment is to suppress the immune system and so we don't see the immune system, in some cases, learning the lesson as well about how to fight off COVID," Chicago Department of Public Health Commissioner Dr. Allison Arwady said Thursday morning.
Chicago's top doctor says the city is "absolutely ready" to administer booster vaccines to people with compromised immune systems should the Food and Drug Administration approve it.
"We are absolutely ready," Arwady said. "We have vaccine available, especially because if this recommendation comes through, it would be for probably 2-3% of eligible Chicagoans where we think about even... kind of the outside estimate of who this might include."
The CDC's advisory panel is scheduled to meet to discuss the decision Friday.
Separately, U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.