FDA close to approving 3rd COVID-19 shot for some immunocompromised people, reports say

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A health worker prepares a dose of the Pfizer-BioNTech vaccine against COVID-19 to inoculate a minor at a vaccination center in Asuncion, on July 23, 2021. – Paraguay started to inoculate children and teenagers from 12 to 17 years-old with underlying diseases. (Photo by NORBERTO DUARTE/AFP via Getty Images)

(NEXSTAR) – 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 was set to announce that people with compromised immune systems 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. However, clinical trials and laboratory research is still being done.

Study finds 3rd shot helps transplant patients

A 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 suppressed immune systems 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 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 wasn’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.

The Associated Press contributed to this report.

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