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



CNN

The U.S. Food and Drug Administration wants to simplify the Covid-19 vaccine process to mimic what the flu vaccine does, according to documents posted online Monday. This may include improving the vaccine composition, vaccination schedules and timely updates of the Covid-19 vaccines.

The FDA said it expects to assess the spread of the coronavirus at least every year and update the annual flu shots in June, which strains to choose for the fall season.

Going forward, the agency says, most people may need just one dose of the latest Covid-19 vaccine to restore protection, regardless of how many previous shots they’ve had. According to an FDA briefing document to the vaccine advisors, two doses may be needed for very young and unexposed, elderly or immunocompromised people.

The agency urged a shift to just one vaccine composition, rather than a combination of monovalent vaccines — currently used for primary vaccines and targeting only one species — and bivalent vaccines — currently enriched and targeting more than one species.

The FDA briefing documents do not say whether the annual shot contains a single strain, two strains or more. The annual flu vaccine protects against four types.

“This simplification of vaccine preparation should reduce complexity, reduce vaccine administration errors due to the complexity of multiple vial approaches, and increase vaccine compliance by allowing more transparent communication,” the FDA said.

The agency’s independent vaccine advisers, the Advisory Committee on Vaccines and Related Biological Products, are scheduled to discuss the future of the Covid-19 vaccine system Thursday and will be asked to vote on whether to recommend parts of the FDA’s plan.

Vaccinationists had mixed reactions.

Dr. Gregory Poland of the Mayo Clinic, who was a member of the FDA’s expert advisory panel, said the first step is to set expectations for achieving the annual vaccination.

“They need to decide what the goal of using the current vaccines is,” said Poland, who studies the body’s response to vaccines. “If it comes to preventing 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 upgraded boosters are with the latest Omicron subversions.

“Effectiveness data is coming out before the BQ and XBB subtypes,” Poland said.

The committee should demand full transparency from the FDA and drug manufacturers as it weighs its decision, he said. He was very concerned that the agency did not share all of the information on bivalent incentives with the advisory committee in June.

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, sees the annual update plan as a balance between what science says is needed to fight the virus and what’s actually happening.

“Trying to do what the science says, I think it’s a balance of adaptability and flexibility. However, the unlikely practicality is that the companies may make this change more than once a year,” he said.

But he notes that this plan also has some drawbacks. Annual updates are fine as long as the virus continues to evolve based on previously circulated viruses. But to capture a radically different variant coming out of left field, as Omiron did, would require the world to have sufficient genomic surveillance.

“We do not have monitoring mechanisms at the international level. We don’t have genomic sequencing on a global scale. “We don’t have the carefully coordinated dance that took decades to build for influenza surveillance for the coronavirus,” Hotez said.

Dr. John Weary, director of the Institute of Immunity at the University of Pennsylvania, has been studying how T-cells, the second-line immune system, deal with different types of the coronavirus.

The answer is that things look great. Although our antibody levels decline within three months, our T-cells appear to last longer – up to nine months – and are thought to be part of the immune system that protects against serious outcomes such as hospitalization. and death.

Although there doesn’t seem to be much of a measurable decline in T-cells over time, Wiry says it supports the FDA’s plan for an annual Covid-19 vaccine.

“Routinely recommending vaccinations as part of your routine health care is something we should be doing,” he said. “A yearly boost with the vaccine helps your T-cells become more adaptive, up-to-date, and able to protect us behind antibodies.”

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

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