In his weekend tweet, FDA’s Makary referred to the Novavax vaccine as “a new product,” presumably because it had been updated to match last year’s common coronavirus strain.
“New products require new clinical studies,” Makary added.
An administration spokesman didn’t respond to specific questions about Pfizer and Moderna but suggested all COVID-19 vaccines could face stricter requirements.
“It’s now been years since COVID has presented the threat it once did, and the urgency to rush approval of boosters without normal oversight no longer exists,” said Andrew Nixon, a Health and Human Services spokesman, in a statement.
The FDA had been treating the annual COVID-19 strain updates exactly as it’s done for decades with flu vaccines — not as new products, but existing ones that are merely adjusted to protect against the latest strains, said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.
Offit said the companies still must perform tests in small numbers of people that show these updated vaccines produce levels of virus-fighting antibodies known to be protective, and they’re closely monitored for safety.
Nixon, the HHS spokesman, suggested the policy might not apply to the flu shot, “which has been tried and tested for more than 80 years.”
Under federal law, the FDA is required to follow established procedures when issuing requirements to drugmakers for approval. If the agency skips certain steps or imposes additional requirements for political reasons, experts say, it could be sued by drugmakers — or even patients, such as those who prefer the Novavax vaccine over its competitors because of an allergy or some other reason.
In addition to large clinical trials conducted before all three COVID-19 vaccines were cleared for use, there’s data on real-world use, said former Health Secretary Xavier Becerra, who oversaw COVID-19 vaccine policy during the Biden administration.
“At the point where I had left, we had put some 700 million COVID vaccines into the arms of Americans,” he said. “That’s a pretty good size clinical trial.”