Nevertheless, although Moderna largely maintained its original plan to use a uniform dose for all participants, it modified its approach after receiving feedback. Specifically, it added a comparison involving a higher-dose vaccine for some older participants and provided the FDA with an additional analysis.
That still didn’t satisfy Prasad, who, according to the Journal’s sources, told FDA staff he plans to issue more refusal letters that seem to catch drug developers off guard. Review staff reportedly pushed back, arguing such actions break with agency practice and could expose it to lawsuits. Prasad is said to have dismissed concerns about possible litigation. Former Trump FDA Commissioner Marty Makary appeared similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”
A senior FDA official told Stat, meanwhile, that the door might not be completely shut on Moderna’s flu vaccine. The official said the company could discard the data for participants 65 and older and, perhaps, apologize.
“It is entirely feasible that if they come back, maybe even show some humility and say, ‘Yes, we didn’t follow your recommendation. Just take a look at the 50 to 65 group, where there’s a little more equipoise,’” the official told Stat. “Then the review team could say, ‘We’ll consider that cohort.’”
The Journal notes that Moderna is at least the ninth company to have received an unexpected rejection from Prasad and his team. The unpredictability is stoking fears about the industry’s ability to secure investment and continue innovating.
Prasad, a blood-cancer specialist without experience in vaccine regulation, is also confronting internal issues at the agency. His management style has created an atmosphere “rife with mistrust and paranoia,” according to Stat. The Journal reports several complaints have been filed against him, including allegations of sexual harassment, retaliation against subordinates, and verbally berating staff.
