FDA suggests revamping COVID vaccinations to once-a-year shot similar to flu

WASHINGTON – The FDA wants to simplify the process for COVID-19 vaccinations, perhaps moving toward an annual shot much the same way as Americans now get flu shots.

In documents released Monday, the Food and Drug Administration outlined changes, including revamping the vaccines themselves.

The agency proposes to retire the original monovalent vaccines, which targeted only one form of coronavirus, and using bivalent vaccines for all primary and booster shots.

The bivalent vaccines could target several strains of COVID-19, much like the annual flu vaccinations contain protection against four strains of flu.

The proposal took some scientists by surprise, including a few of the FDA’s own advisers, The New York Times reported. Those advisers are to discuss the country’s vaccine strategy on Thursday, including which doses should be offered and how they should be scheduled.

“I’m choosing to believe that they are open to advice, and that they haven’t already made up their minds as to exactly what they’re going to do,” Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said of FDA officials in an interview with The Times.

In the documents, the FDA suggests that it could establish a process for gathering vaccine strain recommendations, like the system used for seasonal influenza vaccines. Those selections, based on prevailing and predicted variants, would take place by June to allow for vaccine production by September.

The change is warranted, FDA said, given that COVID-19 has a worldwide impact.

“Similar to the approach with influenza, the global nature of [coronavirus] strain evolution warrants a global response when evaluating and recommending vaccine strain composition changes,” FDA said. “Ideally, any change in vaccine composition, when appropriate, would be implemented broadly and would be coordinated by the World Health Organization with national regulatory authorities.”

Unlike influenza, though, there is no current highly coordinated structure for semi-annual vaccine composition evaluation, FDA said. Given the diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines, developing that global system could be “quite challenging.”

Dr. Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, told CNN developing annual updates would balance what science says is needed to fight the virus and what is actually practical.

He questioned whether companies could make vaccine switches more than once a year. And the world will have to develop genomic surveillance to catch a radically different variant that pops out of left field, as Omicron did.

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

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