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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and Covid combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot, which is due later this year.
The delay was largely expected after Moderna said earlier this month that it does not anticipate approval of the shot until 2026 due to the need for more data on the flu vaccine.
Its shares, which have fallen over 30% this year, were marginally higher at $24.20 in premarket trading.
However, the application withdrawal is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top US health job earlier this year.
Moderna's decision comes a day after the US Food and Drug Administration said it would require new clinical trials for approval of annual Covid-19 boosters for healthy people under 65.
The combination shot comprises a new Covid vaccine and an influenza vaccine, both under development by Moderna.
The company has previously said it does not expect a delay in the FDA's decision for the next-generation Covid vaccine, which is due by the end of the month.
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