FDA close to approving 3rd COVID-19 shot for some immunocompromised people, reports say
immunocompromised
WASHINGTON — The U.S. Food and Drug Administration is set to authorize a COVID-19 vaccine booster
shot for certain groups within the next 48 hours, according to multiple reports.
NBC News first reported the FDA set to announce that immunocompromised people will be allowed
to get a third shot of the Pfizer or Moderna vaccine.
The timing of the announcement could still shift, a source told CNN but added that, as of Wednesday, that
was the projected timeframe.
Both Pfizer and Moderna have made statements saying a booster shot may be needed to better protect
against mutating strains of the virus in the coming months. clinical trials and laboratory research is still
being done.
The study finds 3rd shot helps transplant patients.
The third dose of Moderna’s COVID-19 vaccine substantially improved protection for organ transplant
recipients whose weak immune systems don’t always rev up enough with the standard two shots,
Canadian researchers reported Wednesday.
The study, published in the New England Journal of Medicine, was small but it’s the most rigorous type of
third- dose testing so far for this vulnerable group.
Moderna and similar vaccines provide robust protection for most people, even as the highly contagious
delta variant is surging. But millions with immunocompromised because of transplants, cancer, or
other disorders don’t always get that benefit. There’s limited evidence that an extra dose helps some of
them, something France and Israel already recommend and the U.S. is considering.
Researchers at Toronto’s University Health Network enrolled 120 transplant recipients and two months after their
The second Moderna shot gave half a real third dose and the rest a dummy shot.
Soon after, 55% of the third-dose recipients had a high level of virus-fighting antibodies in their blood,
compared to 18% who only got two doses plus a placebo. Antibodies are only one of the body’s defenses;
third-dose recipients also had more (T cells) that help prevent severe disease. Side effects were mild.
The findings offer “yet more evidence” that many transplant recipients could benefit from an extra dose,
said Dr. Dorry Segev, a Johns Hopkins University transplant surgeon who doesn’t involved with the new
research. But it’s important to check patients’ antibody levels before offering another shot, as some study
participants had pretty good immune responses to regular vaccination added Segev, who is leading a U.S.
study of extra shots in unprotected transplant recipients.
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SOURCE:
FDA close to approving 3rd COVID-19 shot for some immunocompromised people, reports say
