FDA for approving additional boosters for those over 50

(Trends Wide) — The Joe Biden administration is expected to give seniors the option of receiving a second booster shot against Covid-19 as soon as next week.

Two sources familiar with the government’s plans said the US Food and Drug Administration (FDA) plans to license a fourth dose of Pfizer and Moderna’s mRNA vaccines for adults over 50. next week.

The US Centers for Disease Control and Prevention (CDC) is expected to follow soon after with what is known as a permissive recommendation, meaning the injections will not be officially recommended , but they can be given to people who want them, said a source who spoke to Trends Wide on condition of anonymity because they had not been given permission to discuss the details with reporters.

Details of the plans were first reported by The New York Times.

The decision to make the fourth dose available now will bypass the independent scientific advisory groups at both the FDA and the CDC, which would normally meet and publicly review the available science and then make recommendations to the agencies.

Dr. Eric Topol, a cardiologist and director of the Scripps Translational Research Institute in California, said the decision was expected next week, ahead of the April 6 meeting of the Vaccines and Related Biologics Advisory Committee (VRBPAC). acronym), a group of experts who advise the FDA on its decisions about vaccines. Boosters are on the agenda for discussion at that meeting, which will focus on future planning for variant-specific boosters and vaccines.

Topol, who was briefed on the FDA’s plans, said he understood the change would apply to both Pfizer/BioNTech and Moderna vaccines.

Topol also said he was in favor of giving Americans the option of a fourth dose.

“There is strong data from Israel for those over 60 years of age (the only group reported to date) for improved protection (against severe disease) for up to 3 months compared to 3 doses. It is reasonable to extend that and provide it as an option, as the third dose has a pronounced benefit starting at age 50,” Topol wrote in an email to Trends Wide.

Topol noted that the FDA move legitimizes what many Americans are doing anyway. Anyone who wants a fourth dose can go to a pharmacy and get it just by saying that she needs it because she is immunocompromised.

Others felt there was not yet enough science available to support the decision.

Dr. Eric Rubin, editor-in-chief of The New England Journal of Medicine who is part of the FDA’s VRBPAC, said he hadn’t yet seen enough data on the fourth dose to determine if they are necessary for anyone beyond those already are recommended to obtain: severely immunocompromised adults.

“The only data I’ve seen is from participants followed for just a few weeks. The most important information will be how well a fourth dose protects highly vulnerable people against serious illness and death, and I don’t know when that will be available.” Rubin said in an email to Trends Wide Rubin said the FDA might have access to that data, but hadn’t seen it yet.

Dr. Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia and a member of the FDA’s VRBPAC, also said he felt the administration was running ahead of the science.

“Where is the evidence that someone over the age of 50 benefits from a fourth dose? Because the evidence to date seems to support the possibility for people over the age of 65, even though we haven’t seen all the data,” Offit told him. to Trends Wide, speaking about the members of the VRBPAC committee.

“But where is the evidence for a 50- to 64-year-old person? Where is that evidence? Because without that evidence, then there shouldn’t be this recommendation,” he said.