FDA wants to simplify use and update of Covid-19 vaccines

Alzheimer's drug lecanemab gets accelerated FDA approval over safety concerns
Written by admin


The U.S. Food and Drug Administration wants to simplify the Covid-19 vaccine process to be more similar to what happens with the flu shot. documents It was posted online on Monday. This may include modernizing vaccine composition, vaccination schedules, and periodic updates of Covid-19 vaccines.

The FDA said it expects to evaluate circulating strains of the coronavirus at least annually and decide in June which strains to select for the fall season, much like the annual process of updating flu vaccines.

Going forward, most people may only need one dose of the latest Covid-19 vaccine to restore protection, the agency said, regardless of how many previous vaccines they have received. Two doses may be needed for the very young and unexposed, the elderly, or those with compromised immune systems, according to the FDA’s briefing for vaccine advisors.

The agency is calling for a transition to a single vaccine composition instead of a combination of monovalent vaccines currently used for primary vaccines and targeting only one strain, and bivalent vaccines currently used for booster doses targeting multiple strains.

The FDA briefing documents do not say whether the annual vaccine will include a single strain, two strains, or more. The annual flu vaccine provides immunity against four strains.

“Such simplification of vaccine composition should reduce complexity, reduce vaccine administration errors caused by the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing for clearer communication,” the FDA states.

The Vaccines and Related Biologicals Advisory Committee, the agency’s independent vaccine advisors, is scheduled to meet on Thursday to discuss the future of Covid-19 vaccine regimens. asked for votes On whether they recommend parts of the FDA plan.

Vaccine experts have had mixed reactions.

Dr. Gregory Poland of the Mayo Clinic, a former member of the FDA’s expert advisory panel, says the first thing he should do is outline what he expects annual vaccination to accomplish.

Studying how the body responds to vaccines, Poland said, “They will have to decide what the intended use of the current vaccines is.” “If it’s to prevent serious illness and death, we’re already there.”

Would have liked to see data on how effective current updated boosters are against the latest Omicron sub-variants before considering switching to annual boosters.

“The rapidly emerging data on the event precedes the BQ and XBB subvariables,” Poland said.

The committee also said it should seek full transparency from the FDA and drug manufacturers when weighing its decisions. He was very interested in the agency. didn’t share All the data he had on bivalent boosters with the advisory committee in June.

Dr. Peter Hotez, dean of the Baylor College of Medicine’s National School of Tropical Medicine, said he views the annual update plan as a balance between what science says is necessary to fight the virus and what’s actually practical.

“I think it’s a balance of trying to do what the science says, adapting and needing flexibility. Yet the unlikely practicality could cause companies to probably make this transition more than once a year,” he said.

However, he points out that this plan also has some weaknesses. Annual updates are appropriate as long as the virus continues to evolve gradually based on previously circulating viruses. But he questions whether the world has enough genomic surveillance to catch a radically different variant emanating from left field, as Omicron does.

“We don’t have surveillance mechanisms in place globally. We don’t have genome sequencing globally. We don’t have the carefully orchestrated dance that took decades to build for flu surveillance instead of coronavirus surveillance,” Hotez said.

Dr. John Wherry, director of the Institute of Immunology at the University of Pennsylvania, examines how second-line immune defenses called T cells hold up against strains of coronavirus.

The answer is that everything looks pretty good. Although our antibody levels drop about three months after the booster, our T cells seem to stay around longer (up to nine months so far), and they’re thought to be the component of immunity that protects against serious consequences like hospitalization. and death.

Wherry says that while there doesn’t seem to be much measurable decline in T cells over time, the FDA supports an annual Covid-19 vaccine plan.

“Recommending vaccinations regularly as part of your routine health care is something we should do,” he said. “An annual boost with the vaccine will actually help make your T-cells more viable, keep them updated, and put us in a position to protect us behind the antibodies.”

This means that boosters should offer some benefits in the short and long term.

About the author


Leave a Comment