Moderna's Vaccine Ambitions Hit by FDA Roadblock
Moderna faces a setback as shares drop 9% due to the FDA's refusal to review its influenza vaccine application. This decision highlights shifts in U.S. vaccine policies under Health Secretary Robert F. Kennedy Jr., impacting the company's mRNA platform prospects and raising public health concerns.
Shares of Moderna plunged nearly 9% in premarket trading on Wednesday as the U.S. Food and Drug Administration decided not to review the company's application for its experimental influenza vaccine, indicating changes in U.S. vaccine policy. This setback hampers Moderna's efforts to compensate for declining COVID-19 vaccine revenue and underscores doubts about the mRNA platform's long-term potential.
The FDA's decision aligns with broader policy shifts under Health Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, leading to reduced vaccine usage and heightened public health concerns. Under this new framework, longstanding childhood vaccine guidelines have been revoked, impacting immunizations like those for flu and hepatitis A.
Moderna learned that the FDA, in a letter from Center Director Vinay Prasad, declined the review due to the absence of a well-controlled study with a comparator arm. As Moderna's flu and flu/COVID combo vaccines await review in regions like the EU and Canada, analysts suggest U.S. approval may be delayed, despite other flu vaccines already in the market.
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