The Food and Drug Administration is still determining whether it will approve COVID-19 vaccines for next winter, as there is a lack of data on the booster shots, according to Commissioner Dr. Marty Makary.
"We're taking a look," Makary said, reports CBS News Tuesday. "I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots."
He added that there is a "bit of a public trust problem" surrounding COVID-19 vaccine booster shots, leading many healthcare workers to skip them last winter.
"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," he said.
During the Biden administration, the FDA routinely backed plans to update the vaccines every year.
Last year, the updates for the Moderna and Pfizer vaccines were approved in August after the FDA earlier in the year issued its guidance on what strain the shots should target.
Now, the Centers for Disease Control and Prevention is considering whether it should narrow its recommendations for the shots altogether.
Meanwhile, Makary has delayed approval for Novavax's COVID-19 vaccine, which had been expected to be fully approved on April 1.
The pharmaceutical company said Monday the FDA wants it to conduct another clinical trial for the vaccine.
Makary told the "Inside Medicine" newsletter this week that, as there is broad immunity in the population, there are questions whether the Novavax vaccine would provide a benefit.
"Without a study on the new formulation and product, we can't give an honest, evidence-based answer to that question," he said.
Other companies are also being asked to do clinical studies "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.
Makary also praised his special assistant, Dr. Tracy Beth Høeg for her role in the approval of the Novavax application after The Pink Sheet, a trade industry publication, reported that she had been asked to step in on the Novavax application.
Høeg has called for more vaccine scrutiny and told FDA staff and high-ranking officials that the agency will be doing fewer vaccine approvals, reports NBC News, quoting three former government officials familiar with the matter speaking on the condition of anonymity.
Høeg is a sports medicine physician who became prominent during the COVID-19 pandemic after criticizing the vaccines, particularly for use in children.
Meanwhile, former FDA officials Phil Krause and Luciana Boro have criticized the agency's new leadership for intervening in vaccine approvals rather than entrusting the process to career science officials and called on the agency to "stick to its normal processes," reports CBS.
"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.
Sandy Fitzgerald ✉
Sandy Fitzgerald has more than three decades in journalism and serves as a general assignment writer for Newsmax covering news, media, and politics.
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