The U.S. Food and Drug Administration will clear the third dose of COVID-19 coronavirus pandemic news for immune-compromised people

Health officials say that transplant patients and other people with weakened immune systems often do not respond adequately to their first course of vaccine treatment and are at the top of the list of potential COVID-19 boosters.

The US drug regulatory agency is preparing to eliminate the third dose of the Covid vaccine for people with weakened immune systems because a new study shows the benefits of one more injection for transplant patients.

Based on a comparison of additional injections for people with weakened immune systems and placebo, Moderna Inc.’s third dose of vaccine significantly increased the level of antibodies against coronavirus in transplant patients. According to an unnamed person familiar with the matter, the U.S. Food and Drug Administration will amend Moderna and Pfizer Inc.’s (Pfizer Inc.) vaccine licenses as soon as possible on Thursday to provide additional doses for people with compromised immune systems.

Transplant patients and other people with weakened immune systems often do not respond adequately to their first course of vaccine treatment and are at the top of the list of potential Covid-19 boosters. An advisory committee of the US Centers for Disease Control and Prevention will discuss booster injections for immunocompromised people this Friday.

According to an email from the FDA, the agency said it will share more information in the near future, and the agency is closely monitoring data from studies on additional doses for immune-compromised people.

The new study of 120 transplant patients looked at the effect of giving the third dose two months after the second dose. One month after the third injection, 55% of vaccinators developed antibody levels that could provide significant protection.

Researchers from the University of Toronto Health Network found that only 18% of patients who received a placebo injection instead of a third dose showed the required antibody levels. The findings of the Toronto Network’s Ajmera Transplant Center were published in the New England Journal of Medicine on Wednesday.

“I’m very excited about the results,” said study author Atul Humar, director of transplant medicine at Toronto General Hospital, which is one of several University of Toronto hospitals in the network. “This is a dunk.”

He said the results have been shared with Canadian regulars and the US Food and Drug Administration. Moderna was not involved in this research.

Higher quantity

According to Humar, Toronto researchers started the study after noting that transplant patients receiving two doses of the vaccine were still infected with Covid. They chose the Moderna vaccine for the three-dose study because it uses a higher volume of messenger RNA than similar mRNA injections from Pfizer and BioNTech SE.

The number of protective T cells (another key immune fighter) was also higher in patients who received a real third dose instead of a placebo. The additional injections are not associated with any organ rejection cases, and the typical side effects of Covid injections after the third injection are only slightly more common compared to placebo. The study is too small to assess whether the third injection can prevent people from contracting Covid.

“At this moment, the benefits of at least the third dose of the mRNA-1273 vaccine seem to outweigh the risks,” the two editors of the New England Journal concluded in an editorial for the study.

Humar said that bone marrow transplant patients and cancer patients undergoing chemotherapy are also thought to have highly suppressed immune systems.

NBC News reported that the FDA plans to clear the footage early on Wednesday.