(Reuters) – The U.S. Food and Drug Administration (FDA) has delayed announcing its advice on Moderna’s respiratory syncytial virus (RSV) vaccine until the end of May due to “administrative constraints,” the agency said. the American drugmaker said on Friday.
The FDA’s decision extends the wait time for Moderna’s second approved product, but the company said it is on track to have its vaccine reviewed by a panel of advisers to the US Centers for Disease Control and Prevention (CDC). ) on June 26 and 27.
At the meeting, CDC advisers must vote on recommendations on the use of the vaccine and the target population, with prior approval required for marketing the product.
Moderna shares fell almost 1% in pre-market trading on Friday.
Analysts expect sales of $340.8 million (316.20 million euros) this year for the RSV vaccine and more than $800 million in 2025, according to LSEG data.
If approved by the FDA and recommended by the CDC, Moderna’s vaccine will compete in the fall vaccination campaign in the United States with Pfizer and GSK, which dominates the market.
(Written by Patrick Wingrove and Leroy Leo in Bangalore, Augustin Turpin, edited by Kate Entringer)
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