The US Food and Drug Administration approved Moderna’s respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving it a shot at much-needed new revenue from a second product. Moderna’s vaccine was approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older, but with a label indicating the shot was 79% effective at preventing at least two symptoms of RSV, such as cough and fever. Moderna had filed for FDA approval in July on data from a late-stage trial that showed its vaccine was 84% effective at preventing those symptoms, and its shares were down more than 6% in afternoon trading.
Jeffries analyst Michael Yee said in a note that the lower efficacy label was still in line with GSK’s RSV shot Arexvy, the current market leader. Moderna had also previously said its vaccine could be used to treat RSV-associated acute respiratory disease as well as lower respiratory tract disease. RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults aged 65 and older.
The Cambridge, Massachusetts-based company has been banking on new vaccines to make up for vastly lower demand and sales for its Spikevax COVID-19 shot, its only marketed product. Moderna’s RSV shot is the first messenger RNA-based (mRNA) vaccine not for COVID-19 to be approved in the United States. It will be sold under the brand name mRESVIA.
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