Moderna withdraws its flu-COVID combo vaccine application, citing the need for more efficacy data. Increased FDA scrutiny raises concerns in the industry.
Moderna Postpones Flu-COVID Combo Vaccine Approval Amid Rising Regulatory Hurdles
Moderna Withdraws Application, Cites Data Requirements
Biotechnology giant Moderna has decided to pull back its application for approval of its flu and COVID-19 combination vaccine. The company announced on Wednesday that it would await efficacy data from a crucial late-stage trial of its influenza shot, expected later this year.
Approval Delayed Until 2026
The decision aligns with Moderna’s earlier statements indicating that the shot is unlikely to receive regulatory clearance before 2026 due to insufficient flu vaccine data. Despite this setback, Moderna’s stock saw a slight increase, trading at $24.20 in premarket hours, though the company has faced a 30% decline in its shares this year.
Regulatory Scrutiny Intensifies
Moderna’s withdrawal comes amidst heightened scrutiny over vaccine approvals following Robert F. Kennedy Jr.’s appointment as the head of the U.S. Department of Health and Human Services earlier this year. The FDA has tightened its review process, recently announcing the requirement for new clinical trials before granting approval for annual COVID-19 boosters for individuals under 65.
Impact on Moderna’s Business Strategy
The combination shot includes a new COVID vaccine and an influenza vaccine, both under development. Moderna has clarified that while this setback affects its combo shot, the FDA’s decision on its next-generation COVID vaccine remains on track for the end of the month.
Financial and Industry Implications
Moderna has been counting on new mRNA vaccines to compensate for declining COVID-19 revenues. Investor sentiment has been shaken by Kennedy’s appointment, given his skeptical stance on vaccines. Meanwhile, rival Novavax secured FDA approval for its COVID-19 vaccine last week, though its use has been restricted to individuals at higher risk due to the illness.
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