Health
The FDA has set up to clear a third COVID shot for immunocompromised patients
As new studies show the benefits of additional injections in transplant patients, US drug regulators are set to clear a third dose of the COVID-19 vaccine for people with a weakened immune system.
A third dose of the Moderna Inc. vaccine significantly increased antibody levels against coronavirus in transplant patients, according to an additional shot comparison with placebo in people with a weak immune system. The Food and Drug Administration will amend vaccination approvals from both Moderna and Pfizer Inc. on Thursday to allow people with a weakened immune system to receive additional doses, according to someone familiar with the issue, who spoke on condition of anonymity. It’s a schedule.
Transplant patients and other patients with a weak immune system often do not respond adequately to the first vaccine course and are at the top of the list for potential COVID-19 boosters. The US Centers for Disease Control and Prevention Advisory Board Discuss A booster shot for people with weakened immunity on Friday.
The FDA is closely monitoring data on additional dose studies for people with immunodeficiency, and said it will share more information in the near future, according to an email from the FDA.
A new study of 120 transplant patients examined the effect of a third dose given two to two months later. One month after the third injection, 55% of those who received it developed antibody levels that could provide significant protection.
Researchers at the University Health Network in Toronto found that only 18% of patients who received placebo, rather than the third dose, showed desirable antibody levels. Findings from the Azimera Transplant Center on the Toronto network were published Wednesday at the New England Journal of Medicine.
“I’m very excited about the results,” said Atul Humar, research author and head of transplant medicine at the Toronto General Hospital, one of the University of Toronto hospitals in the network. “It’s a slam dunk.”
He said the results were shared with Canadian regulars and the US Food and Drug Administration. Moderna played no role in this study.
Researchers in Toronto began their studies after they realized that the two-vaccinated transplant patients were still ill with COVID-19, Humar said. They chose the Moderna vaccine for their triple-dose study because they use more messenger RNA than similar mRNAs taken from Pfizer and BioNTech.
The number of protected T cells, another important immune fighter, was also higher in patients who received the actual third dose rather than placebo. The extra shots were not associated with any case of organ rejection, and the typical side effects of COVID-19 shots were slightly higher after the third dose compared to placebo. The study was too small to assess whether the third shot prevented people from getting sick with COVID-19.
“At this point, the benefits of triple vaccination with at least the mRNA-1273 vaccine appear to outweigh the risks,” two editors of the New England Journal concluded in an editorial accompanying the study. ..
Bone marrow transplant patients and cancer patients receiving chemotherapy are also thought to have a high degree of suppression of the immune system, Humar said.
NBC News reported news of the FDA’s plans to clear the shot early Wednesday.
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Sources 2/ https://www.latimes.com/science/story/2021-08-11/fda-third-covid-19-shot-immunocompromised-patients The mention sources can contact us to remove/changing this article |
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