Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in "radical" changes to how it signs off on new vaccines.
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN.
It isn't immediately clear which "new" vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.
An HHS spokesperson did not respond to Fierce Pharma’s request for comment. The Washington Post was the first to report the FDA policy change.
An HHS official told CNN the new policy pertains to COVID shots rather than flu vaccines. Flu shots have been "tried and tested” for decades, while COVID-19 vaccines are "new and must have more gold standard science to ensure safety and efficacy for the public," the official told the news outlet.
For years now, the FDA has allowed COVID-19 vaccine manufacturers to leverage prior clinical efficacy data—rather than results from new trials—when routinely updating their shots to match the latest variants. When the FDA endorsed updated COVID-19 vaccines last summer, for example, the agency said it considered “manufacturing and nonclinical data” to grant the OKs.
Last year, FDA advisors recommended variants for the updated shots in June, and the agency endorsed the tweaked vaccines in August. It's not immediately clear whether COVID-19 vaccine makers could meet the agency's new requirement in order to release their updated vaccines by the time virus circulation typically ramps up in the fall and winter.
Representatives for the two largest COVID-19 vaccine producers, Pfizer and Moderna, did not immediately respond to Fierce Pharma's request for comment.
While the announcement may come as somewhat of a surprise, in hindsight, there were indications this sort of policy change was in the works.
Before the official word came out from the HHS, FDA Commissioner Marty Makary, M.D., seemed to hint at changes happening behind the scenes at the agency.
Speaking with CBS News’ chief Washington correspondent Major Garrett earlier this week, Makary said the FDA is "taking a look" at whether to approve a new set of COVID-19 shots this year. While that statement alone raised some eyebrows, Makary went on to add that companies are being asked to run a “basic clinical study, so we can educate the population and have information to work with.”
Before that interview, Novavax had a high-profile regulatory mix-up with its COVID-19 vaccine. The company believed—and still does—that its shot was ready for approval by April 1. When the date came and went with no action from the FDA, reports emerged that the agency had issued a last-minute request for more data.
Later, Makary commented on X that the company was "trying to introduce" a new product "with a study of a different product from 2021." He added that the Trump administration would prioritize the "gold standard of science."
In response to the Novavax situation, former FDA officials Phil Krause, M.D., and Luciana Borio, M.D., wrote in BioCentury this week that the agency should "stick to its normal processes and trust its review teams."