FDA's Vaccine Policy Shift Jolts Moderna Shares

Moderna shares fell 10.3% following the FDA's refusal to review their influenza vaccine, highlighting shifts in U.S. vaccine policy. The FDA's decision, based on Moderna's chosen comparator vaccine, may prolong approval in the U.S. despite ongoing reviews in other regions, such as the EU and Canada.

Shares of Moderna plunged by 10.3% in premarket trading on Wednesday after a setback from the U.S. Food and Drug Administration. The regulatory body declined to review the pharmaceutical company's new influenza vaccine application, reflecting significant shifts in the country's vaccine policies.

According to Moderna, the key factor in the FDA's refusal was their comparison of the mRNA-1010 vaccine with an established standard-dose seasonal influenza vaccine. Analysts from Jefferies note this decision could prolong the U.S. approval timeline for both its standalone flu and combination flu/COVID vaccines.

Moderna has requested a meeting with the FDA to clarify the way forward, citing contradictions between the FDA's latest directive and previous communications. Despite the U.S. setback, the vaccine continues its review process in the EU, Canada, and Australia, potentially receiving approvals by 2026 or 2027.

(With inputs from agencies.)