By Rashika Singh
Feb 11 (Reuters) – Shares of Moderna slumped nearly 9% in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to review the company’s application for approval of its experimental influenza vaccine, underscoring shifts in U.S. vaccine policy.
The decision deals a blow to Moderna’s ambitions to plug the decline in its COVID-19 vaccine revenue and demonstrate the long-term viability of its mRNA platform.
Sweeping changes to U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr., a longtime antivaccine activist, have led to reduced vaccine usage and sparked concerns about public health risks that may be difficult to reverse.
“It is hard for us not to think that the decision today fits in the broader scheme of how the Administration views the vaccine category more broadly and the mRNA technology more specifically,” said RBC Capital Markets analyst Luca Issi.
The U.S. last month ended its longstanding childhood immunization guidance that all children receive inoculations against flu, hepatitis A and other diseases.
Moderna said it was notified that the health regulator will not initiate a review of its application in a letter, signed by Center Director Vinay Prasad, which cited the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care.”
This raises the risk of a more protracted U.S. path for both the standalone flu shot and Moderna’s flu/COVID combination vaccine, given the FDA’s stance on the comparator, Jefferies analysts said.
The vaccine is currently under review in the European Union, Canada, and Australia, with the company expecting potential approvals to come in late 2026 or early 2027.
Several FDA-approved flu vaccines, including those produced by UK’s AstraZeneca and France’s Sanofi, are currently available in the U.S. market.
Moderna’s shares have risen about 42% so far this year after falling 29% in 2025.
(Reporting by Rashika Singh in Bengaluru; Additional reporting by Danilo Masoni in Milan and Mariam Sunny in Bengaluru; Editing by Amanda Cooper, Mrigank Dhaniwala and Leroy Leo)
