FDA Does a 180 on Moderna Flu Shot Review

The FDA has made a U-turn on Moderna's experimental flu shot. After refusing to even review the vaccine last week over concerns about how the pivotal trial was designed, the agency has now agreed to evaluate it for potential approval, Moderna said Wednesday, per the New York Times. The company split its request by age group: full approval for adults 50 to 64, and a faster, "accelerated" pathway for those 65 and up, paired with a promise to run another study in the older group if the vaccine hits the market.

The agency has set an August deadline for a decision, which could put the shot in play for older adults as soon as this fall's flu season. The vaccine uses messenger RNA (mRNA) technology—the same platform behind COVID shots that public health experts broadly consider safe, but that Health Secretary Robert F. Kennedy Jr. has criticized and moved to limit in federal recommendations. The initial rejection was signed by the FDA's top vaccine official, Dr. Vinay Prasad, who questioned the comparison vaccine used in seniors in a 41,000-person trial.

Moderna says it was aware of the FDA's initial concerns over the control vaccine, but it adds that the agency ultimately said that vaccine was fine to use, per STAT. Moderna, which poured hundreds of millions into the research, plus a $750 million investment from Blackstone, is also seeking approvals in Europe, Canada, and Australia. "We appreciate the FDA's engagement in a constructive ... meeting and its agreement to advance our application for review," says Moderna CEO Stephane Bancel in a release.