• FDA authorizes third vaccine dose for immunocompromised,
Americans at high risk from COVID-19 because of severely weakened immune systems are now allowed to get a third vaccination in hopes of better protection, a policy change endorsed Friday by influential government advisers.
The Food and Drug Administration ruled that transplant recipients and other similarly immunecompromised patients can get a third dose of either the Pfizer or Moderna vaccine. But the decision offers an extra dose only to those high-risk groups — not the general public.
These patients have been clamoring for months for better protection, some of them traveling across state lines or lying to get another dose. About 1.1 million people already have gotten at least a third dose of the Pfizer or Moderna vaccines on their own, the Centers for Disease Control and Prevention revealed, although it’s not clear how many did so because they had weakened immune systems.
On Friday, UPMC announced it was scheduling patients for the third shot.
Advisers to the CDC grappled with exactly who qualifies before unanimously endorsing the FDA’s decision to limit the doses to immune-compromised patients..
It’s “an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination,” CDC Director Dr. Rochelle Walensky said in a statement after signing off on the recommendation.
The Pfizer and Moderna vaccines offer powerful protection for otherwise healthy people, but many who take immune-suppressing medications or have diseases that tamp down their immune systems generally get less benefit from the standard two doses. The CDC cited one study suggesting about 40% to 44% of people hospitalized for a so-called breakthrough case — infection after vaccination — are among the immune-compromised.
Those hospitalized patients “did all the right things — they’re just suffering from a lack of good vaccine protection,” said Dr. Camille Kotton of Massachusetts General Hospital, one of CDC’s advisers.
Roughly 7 million American adults are classified as immune-compromised, but the FDA singled out transplant recipients and others with similar levels of immune suppression. The FDA didn’t spell out exactly who falls into those other categories. But according to the CDC, people with blood cancers, those taking certain cancer chemotherapies and those taking certain medications such as rituximab for rheumatoid arthritis tend to have especially poor responses to vaccination.
For now, the new policy allows a third dose of the Pfizer vaccine for children as young as 12 who also meet the high-risk requirement, but adults only for a third Moderna dose. That’s because the Pfizer vaccine currently is the only authorized option for Americans under 18. That could change if Moderna’s vaccine eventually is allowed for teens.
The government isn’t requiring either a doctor’s note or a blood test. Patients just need to tell the vaccine provider why they’re seeking another dose. “We would want to make that as easy as possible,” said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University.
Shots given under FDA’s emergency use authorization are free.
A third dose helps at least some people. Canadian researchers this week reported 55% of transplant recipients given a third dose two months after standard vaccination had good antibody levels compared to 18% who were given a dummy third shot for comparison. Health experts urged these high-risk patients to continue masking and taking other precautions since there’s no guarantee a third dose will work.
The government also encourages the third dose to be the same as the first two but doesn’t mandate it.