FDA advisors look to simpler vaccinations for the future

The FDA is ready to move COVID vaccinations to a flu-like model, in which the agency would release a single booster shot each fall, based on its best guess at what variants will be circulating in winter.
The agency convened its vaccine advisory committee Jan. 26 to discuss the potential shift and the questions it raises.
A key question for the committee was whether the agency should simplify the nation’s vaccine offerings.
Currently, people who get the primary series receive original-formula vaccines, which were designed to match the coronavirus strain that emerged in Wuhan more than three years ago. This fall’s booster, in contrast, is a mix of that vaccine plus one tailored to the omicron strain.
Committee member Dr. David Kim, who directs the Department of Health and Human Services’ National Vaccine Program, noted that the current situation has forced pharmacists and physicians to rely on complex diagrams and flow charts just to pick out the right vial for each patient.
The committee unanimously voted that the FDA should simplify the process by dropping the old vaccine formula and using the current bivalent shot for all vaccinations going forward.
“Bivalent is better, simple is better,” said temporary voting member Dr. Mark Sawyer of UC San Diego.
It’s not clear exactly when the change will take place.
The real-world value of the current bivalent shots remains uncertain, notes Keren Landman, who lays out the latest evidence at Vox.
Experts say it’s not feasible to chase after a vaccine for every new variant, but that improvements to the vaccine over time are still possible.
The FDA floated the idea of picking a new vaccine formula every June, which would give Pfizer and Moderna time to produce new mRNA vaccines by September. Releasing vaccines in early fall would, theoretically, allow the populace to be vaccinated and ready for a winter surge.
But Novavax, which makes a protein-based vaccine, said it would need six months to reformulate its product for a fall campaign. Several committee members urged the FDA not to overlook Novavax, which claims its shots provide broader immunity to variants than the mRNA vaccines.
Committee members also cautioned that the coronavirus is not influenza, and that copying the vaccine design process and schedule from the flu may not be the most appropriate strategy.
Other experts have noted that the coronavirus has yet to settle into a clear seasonal schedule like flu, and that there’s not enough evidence to assume one annual shot is the way to go, as reports Cecelia Smith-Schoenwalder at U.S. News & World Report.
The advisory committee also questioned what the goal of annual vaccination campaigns would be: Are we trying to prevent transmission, severe infection, or deaths?
“The goal is to keep people out of the hospital,” said committee member Dr. Paul Offit of the Children’s Hospital of Philadelphia. Current vaccines, he said, already do that.
Offit echoed his colleagues’ comments when he said the committee needs more data on who’s still dying from the coronavirus to decide “who gets vaccinated, with what, and when.”
Emergency room visits for all three “tripledemic” viruses have declined. CDC