“I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data,” Makary said.
His answer marks a change from during the Biden administration, when FDA officials backed plans to routinely update the COVID-19 vaccines each year.
Last year, the FDA issued guidance on what strain should be targeted by the shots for the following winter. Updates to Moderna and Pfizer’s COVID shots for the new strain were approved in August.
The Centers for Disease Control and Prevention is also now weighing whether to significantly narrow its recommendations for COVID-19 vaccines.
Makary’s remarks echo his justification for delaying Novavax’s COVID-19 vaccine, which was expected to get full approval on April 1. Novavax said Monday that the FDA had asked the company to commit to another clinical trial of the shot.
“Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question,” Makary told the newsletter “Inside Medicine” this week.
Multiple companies are now also being asked “to do clinical studies, a basic clinical study, so we can educate the population and have information to work with,” Makary told CBS News.
“It’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them,” he said.
He also praised his special assistant, Dr. Tracy Beth Høeg, when asked what role she played in the agency’s evaluation of Novavax’s application.
“Dr. Høeg is an amazing M.D.-Ph.D. who has joined my staff as a special assistant to the commissioner. And she is involved in reviewing data sets at the agency. And I’m really excited to have her in the process,” Makary said.
Trade industry publication The Pink Sheet previously reported that Høeg had been asked to step in on Novavax’s application. Høeg was also added to the CDC’s Advisory Committee on Immunizations, in a slot previously filled by a career vaccines official from the FDA.
Former FDA officials have criticized the agency’s new political leadership for their intervention in vaccine approvals, a process which is usually entrusted to career scientific officials.
In a commentary published this week, former officials Phil Krause and Luciana Borio called on the FDA to “stick to its normal processes.”
“Shifting standards and late-stage demands for new data — based on faulty scientific assumptions — erode trust, delay access to important tools, and discourage developers from advancing vaccine innovation,” they wrote.