FDA approves additional dose of Covid vaccine for immunocompromised people

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Millions of Americans whose immune systems have been undermined by disease or medical treatment, and who are already fully vaccinated against Covid with Pfizer or Moderna vaccines, will be allowed to receive a third dose, according to federal decisions taken Thursday evening and Friday.

Decisions by the Food and Drug Administration and the Advisory Committee on Immunization Practices, an external advisory group of the Centers for Disease Control and Prevention, have allowed U.S. health policy to catch up with research showing that transplant recipients and cancer patients are not fully protected by two injections, as well as to patients who were already receiving unapproved doses themselves. Indeed, it changes the series of vaccines authorized for people with weakened immune systems from two doses to three, the third dose being administered 28 days or more after the second.

But this is not a global change. It only covers people with what the FDA and ACIP call “moderate to severe immune compromise”. It only allows third injections for 12 years and over, because no vaccine has been authorized for pre-adolescents or children. And it does not approve any additional injections for immunocompromised people who are among the 12 million recipients of the Johnson & Johnson single-dose vaccine, because there are no data yet to predict their reactions.

The FDA and the committee were careful not to call the third doses “boosters,” in the hope of distinguishing between improving initial protection in people with low immunity and renewing immunity in those with low immunity. the rest of the population if the vaccine’s effectiveness wanes against future variants. But, overall, the move could still be controversial. The World Health Organization has pleaded with rich countries to stop providing extra doses until poor countries can get more vaccines.

The decision to add a dose for immunocompromised people has been around for some time. ACIP, which is a group of medical researchers and representatives of professional associations that help the CDC shaping vaccine policy, reviewed evidence of the move last month. CDC Director Rochelle Walensky signaled his imminent arrival Thursday afternoon during a briefing from the White House Covid-19 response team. “This action aims to ensure that our most vulnerable – who may need an extra dose to improve their biological responses to vaccines – are better protected against Covid-19,” she said.

FDA changed its orientation on vaccines late Thursday night, amending the emergency use permissions for the Pfizer and Moderna formulas to include the three-dose series and setting the stage for the committee, which had already scheduled a discussion on Friday morning. This meeting ended with a unanimous vote in favor of the third doses.

But the immediate trigger for the change, alongside the outbreak of the extra-contagious Delta variant that is overwhelming the United States, has been studies of Canada and France which were published on Wednesday and Thursday in the New England Journal of Medicine (although shared with federal agencies beforehand). The two documented that small groups of transplant recipients who had received two doses of the vaccine had low levels of antibodies, but gained significant immune protection after a third dose.

“I really believe these results are final; I think it’s a slam dunk, ”Atul Humar, a doctor and director of transplantation at the University of Toronto and lead author of the Canadian trial, said Thursday before the FDA and CDC acted. This study, involving 120 organ transplant patients, showed not only improvements in antibodies, but also higher T-cell responses in third-dose recipients compared to participants who received placebo. “I think the results are convincing enough that this will lead to a change in regulatory guidelines recommending a third dose for these patients,” he said.



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