A fourth COVID booster shot should be viewed as a “stop-gap” measure, concluding that “we simply can’t be boosting people as frequently as we are,” according to a top FDA official.
In a report by the TrialSite, the remark was made by Dr. Peter Marks, director of the Center for Biologics Evaluation and Research and the one who leads the Food and Drug Administration office responsible for vaccine safety and efficacy, at a recent meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee.
Marks, who announced the agency’s decision last week to authorize second boosters for certain groups, said he agreed that boosting people every four months wasn’t a long-term plan. In fact, he called the latest round of shots “a stopgap measure” until there was a better system in place to consider booster strategy more broadly. He said health authorities wanted to provide older adults, who’ve taken the brunt of Covid’s damage, with an extra layer of protection in the interim.
Data presented to the panel showed that current vaccines lose much of their effectiveness in preventing infections from the Omicron variant of the virus, but were better at preventing severe disease.
Marks told the committee:
“I think we are very much on board with the idea that we simply can’t be boosting people as frequently as we are.”
“I’m the first to acknowledge that this additional fourth booster dose that was authorized was a stopgap measure until we got things in place for the potential next booster given the emerging data.”
The FDA authorized fourth shots for adults ages 50 and older last month without consulting the committee, a decision that has divided scientists and physicians, some of whom believe that there isn’t sufficient data to support additional shots.
Marks acknowledged that there is a compressed timetable for deciding upon booster makeup, but there may be “some wiggle room” that could allow for a determination in May or June.
Marks said the FDA didn’t consult the committee because the drug regulator viewed the authorization as a way to give people more vulnerable to severe disease additional protection until a broader decision is made for the rest of the population.
Many of the outside scientists raised concerns that the agency’s preferred timeline would not allow manufacturers to run full trials to generate clinical data on a new vaccine’s effectiveness. They may instead have to rely on comparing immune responses generated by new vaccines to the old ones.
The FDA said it was hoping next-generation vaccines would be to tackle multiple variants.
“Pivoting toward a monovalent vaccine directed at something like Omicron runs the risk of really narrowing the breadth of coverage for people who might be getting that modified vaccine as their primary series,” FDA scientist Doran Fink said.
The advisory panel did not vote on any specific vaccines, but the agency said their discussions could help forge a strategy for future use of booster doses.