FDA Does Sharp U-Turn On Application For Moderna Flu Vaccine

The FDA this week agreed to begin review of the latest Moderna flu shot after shooting it down. Why?

Well, the F.D.A. didn't give a detailed explanation yesterday as to why it suddenly changed direction. But the initial refusal to even consider the application drew a lot of public criticism, and startled Big Pharma as well as investors. Blackstone alone invested $750 million in Moderna’s development of a flu vaccine.

Industry executives have gotten vocal about expressing their opinions about the administration’s destruction of vaccine policy and the F.D.A.’s recent pattern of rejecting drugs after years-long agreements on study standards. A number of drug companies have also raised similar concerns after the F.D.A. refused to review their applications or denied approvals.

Dr. Stephen Hoge, Moderna’s president, said on Fox Business this week that Moderna and other drug developers needed clear and consistent rules from regulators. “What we can’t have is somewhat arbitrary changes to those rules after the game has been played,” he said.