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



CNN

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to the same extent as the flu vaccine, according to a document posted online on Monday. That could include rescheduling vaccines, vaccination schedules and timely updates of Covid-19 vaccines.

The FDA said it expects to review the type of coronavirus at least annually and decide in June which type to choose for the fall season, as part of the process to improve the vaccine every year.

Going forward, the agency said, many people may need just one of the latest Covid-19 vaccines to restore protection, regardless of how many shots they received before. Two doses may be needed for younger unexposed, elderly or immunocompromised individuals, according to the FDA’s summary of its vaccine advisors.

The agency is encouraging a switch to only one vaccine instead of a combination of monovalent vaccines – currently used for primary vaccination and targeting only one species – and bivalent vaccines – which are -currently used for promotion processes and targeting more than one model.

The FDA brief does not say whether the annual shot will contain one type, two types or more. The annual influenza vaccine provides immunity against four strains.

“This simple formulation of vaccines should reduce confusion, reduce vaccine administration errors due to the confusion of the number of different vial indications, and may increase vaccine compliance by allowing clear communication ,” the FDA said.

The agency’s independent vaccine advisers, the Vaccine Advisory Committee, will meet Thursday to discuss the future of the Covid-19 vaccine system, and will be asked to vote on whether they support part of the FDA plan.

Vaccination experts have mixed responses.

Dr. Gregory Poland of the Mayo Clinic, a former member of the FDA’s expert advisory panel, said the first thing he needs to do is clarify what he expects the annual vaccine to achieve.

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

Before considering moving to annual boosters, he would like to see data on how effective the current updated boosters are against the new Omicron subvariants.

“The data that continues to go out in terms of efficacy is pre-BQ and XBB subvariants,” Poland said.

The committee should also seek full understanding from the FDA and drug manufacturers when considering its decision, he said. He was very concerned that the agency did not share all the data it had on bivalent stimulants with the advisory committee in June.

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

“I think it is a balance, trying to do what science says, which is the need for change and change. But it is effective that it is impossible that the companies can make the change more than once in years,” he said.

But the plan also has some weaknesses, he says. Annual updates are fine as long as the virus continues to spread, depending on the viruses that were circulating before. But he questions whether the world has enough genomic research to get the diversity that is emerging in the left field, as Omicron did.

“We don’t have a universal monitoring system. We do not have a universal genomic sequence. We don’t have the carefully planned tracks that took decades to build for influenza surveillance where there is for coronavirus surveillance,” Hotez said.

Dr. John Wherry, director of the Institute for Immunology at the University of Pennsylvania, has been studying how the second type of immune defense, called T-cells, supports the coronavirus.

The answer is that things are going well. Although our immune levels decline within about three months of stimulation, our T cells seem to stick around for a long time – up to nine months they are thought to be part of the immune system. -Protected against serious consequences such as hospitalization. and death.

Although it doesn’t seem like there will be a significant reduction in T cells over time, Wherry says, he supports the FDA’s plan for the annual Covid-19 vaccine.

“Recommending routine vaccinations as part of your routine health care is something we should be doing,” he said. “Getting a booster shot every year will help keep your T cells healthy, renew them and keep them in position to protect us in the wake of the vaccine.”

This means that lifters should provide some benefits in the short and long term.

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