FDA seeks to simplify access and updating of COVID-19 vaccines


The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to see what happens with the flu vaccine, according to documents posted online on Monday. This may include streamlining vaccine composition, immunization schedules and periodic updates to COVID-19 vaccines.

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

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

The agency is urging a shift toward just one vaccine structure instead of 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 target more than one strain.

The FDA briefing documents do not say whether the annual shot will include one strain, two strains or more. The annual influenza vaccine immunizes against four strains.

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

The agency’s independent vaccine advisor, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet Thursday to discuss future COVID-19 vaccine regulations and will be asked to vote on whether to approve the FDA’s plan. Recommend parts of.

Vaccine experts had a mixed reaction.

Dr. Gregory Poland of the Mayo Clinic, a former member of the FDA’s expert advisory panel, says it should first outline what annual vaccination is expected to achieve.

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

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

“The data that are continuing to emerge with regard to efficacy are prior to the BQ and XBB subvariants,” Poland said.

He said the committee should demand full transparency from the FDA and drug makers when weighing their decisions. He was very concerned that the agency had not shared all the data on the bivalent booster with the advisory committee in June.

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

“I think it’s a balance, trying to do what the science says, which requires adaptability and flexibility. Yet the practicalities that are unlikely will make companies probably make that switch more than once a year.” Might,” he said.

But the plan also has some weaknesses, he notes. Annual updates are fine as long as the virus continues to evolve incrementally based on previously circulated viruses. But he questions whether the world has enough genomic surveillance to catch a radically different variant coming out of left field, as Omicron did.

“We do not have a monitoring mechanism globally. We don’t have genomic sequencing globally. We don’t have a carefully orchestrated dance of building up to influenza surveillance for coronavirus surveillance,” Hotez said.

Dr. John Wherry, director of the Institute for Immunology at the University of Pennsylvania, is studying how second-line immune defenders, called T-cells, are holding up against the coronavirus strain.

The answer is that things are looking pretty good. Even though our antibody levels drop within about three months after a booster, our T-cells stick around for a long time — up to nine months so far — and are thought to be the component of immunity that can lead to serious consequences, such as hospitalization. saves from and death.

Even though there doesn’t seem to be much measurable decline in T-cells over time, Verey says, he supports the FDA’s plan for an annual COVID-19 vaccine.

“Recommending vaccines routinely as part of your regular health care is something we should be doing,” he said. “An annual boost with the vaccine will really help make your T-cells more fit, keep them up to date and put them in a position to protect us on the back of antibodies.”

This means that the booster should provide some benefit in the short and long term.


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