Moderna, the biotechnology firm known for its COVID-19 vaccine, is facing significant hurdles in its pursuit of regulatory approval for a forthcoming flu vaccine. The company initially adhered to its plan of administering a standard dose to all trial participants. However, in response to feedback from regulators, it made strategic adjustments, including a comparison involving a high-dose vaccine targeted at older adults and submitting an additional analysis to the Food and Drug Administration (FDA).
Despite these efforts, tensions have arisen within the FDA. Reports indicate that a senior figure within the agency expressed intentions to send more refusal letters that could catch drug developers off-guard, raising concerns among FDA staff about the implications of such actions. The agency’s review team cautioned that these strategies diverge from established practices and could expose the FDA to potential litigation. The official reportedly downplayed these legal risks, mirroring sentiments expressed by former FDA Commissioner Marty Makary, who suggested that Moderna’s clinical trial might be deemed “unethical.”
The situation remains fluid, as a senior FDA official indicated that the door for approval of Moderna’s flu vaccine might still be ajar. One potential path forward for the company could involve withdrawing the data for participants aged 65 and older and approaching the FDA with a more conciliatory tone. This strategy could involve a focus on the 50 to 65 age group, which presents a more favorable balance of risk and benefit, allowing the review team to reconsider its decision.
Moderna’s predicament is not isolated; it marks at least the ninth instance where Prasad and his team have issued unexpected rejections to drug developers. This inconsistency has generated apprehension within the pharmaceutical industry regarding its capacity to attract investment and foster innovation.
Internally, Prasad, a specialist in blood cancer with no background in vaccine regulation, has come under scrutiny for his leadership style. Reports describe a workplace atmosphere laden with mistrust and paranoia. Allegations against him include sexual harassment, retaliation against staff, and instances of verbal abuse, further complicating the current state of affairs within the agency.
