FDA wants to simplify the use and updating of Covid-19 vaccines



CNN

The U.S. Food and Drug Administration wants to streamline the Covid-19 vaccine process to resemble what happens with the flu vaccine, according to documents posted online Monday. This includes simplifying the vaccine formulation, the immunization schedule and updating the cycle 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, similar to the process of updating annual flu vaccines.

Going forward, the agency said, most people may need just one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they’ve already had. According to the FDA’s summary document for vaccine advisors, two doses may be needed for people who are very young and have not been exposed, who are elderly or who have weakened immune systems.

The agency is calling for a change to a combination of monovalent vaccines — which are currently used for primary shots and target only one strain — and bivalent vaccines — which are currently used for booster doses and Marks more than one stress.

The FDA summary documents do not say whether the annual shot will contain a single strain, two strains or more. The annual flu vaccine immunizes against four types.

The FDA said: “This simplification of vaccine formulation should reduce complexity, reduce vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication. ”

The agency’s independent vaccine advisers, the Advisory Committee on Vaccines and Related Biological Products, will meet Thursday to discuss the future of Covid-19 vaccine regimens and be asked to vote on whether they should be part of the FDA’s plan. suggests

Vaccine experts had mixed reactions.

The Mayo Clinic’s Dr. Gregory Poland, a former member of the FDA’s expert advisory panel, says the first thing to do is figure out what to expect from the annual vaccination.

“They have to decide what the purpose of using the current vaccines is,” said Poland, who studies how the body responds to vaccines. “If it’s going to prevent serious illness and death, we’re already there.”

Before moving to annual boosters is considered, he wants to see data on how effective the current updated boosters are against the latest omicron sub-variants.

“The data on efficacy that has been consistently debunked predates the BQ and XBB subtypes,” Poland said.

The committee should demand full transparency from the FDA and drug manufacturers when weighing its decisions, he said. He was very concerned that the agency had not shared all the information about the two-way boosters with the advisory committee in June.

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

“I think it’s a balance, trying to do what the science says, which is the need for adaptability and flexibility. Yet the practicality is that it’s unlikely companies might make the switch more than once a year,” he said.

But this plan also has some drawbacks, he noted. Annual updates are fine as long as the virus evolves gradually, based on previous outbreaks. But he questions whether the world has enough genomic oversight to catch a fundamentally different species that came out of left field, as Omicron did.

“We don’t have surveillance mechanisms at the global level. We don’t have genomic sequencing at the global level. We don’t have the carefully orchestrated dance that took decades to develop for the surveillance of the coronavirus to the surveillance of the flu,” Hotez said.

Dr. John Weary, director of the Institute of Immunity at the University of Pennsylvania, has studied how second-line defenders of the immune system, called T-cells, resist coronavirus strains.

The answer is that things look great. Although our antibody levels decline within about three months of a booster, our T-cells persist for a long time—up to nine months—and are believed to be part of the immune system that prevents serious outcomes such as Protects against hospitalization. and death

Although there doesn’t appear to be a measurable decline in T-cells over time, Weary says, he supports the FDA’s plan for an annual Covid-19 vaccine.

“Offering vaccines regularly as part of your routine health care is what we need to do,” he said. “An annual boost with the vaccine will actually help your T-cells become more fit, keep them fresh and in a position to protect us behind the antibodies.”

This means that the promoters must offer some benefits in the short and long term.

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