(Reuters) -Moderna announced on Friday that the U.S. Food and Drug Administration approved its respiratory syncytial virus (RSV) vaccine. This approval offers the company a chance for additional revenue from a second product.
The approved Moderna vaccine targets prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. The label specifies its efficacy at 79% in preventing at least two symptoms of RSV.
Moderna sought FDA approval in July based on data showing 84% efficacy in preventing symptoms. Its shares dropped over 6% in afternoon trading.
In a note, Jeffries analyst Michael Yee stated that the lower efficacy label aligned with GSK’s RSV shot Arexvy, the current market leader.
Moderna had also previously stated that its vaccine could 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, the first messenger RNA-based (mRNA) vaccine not for COVID-19, gained approval in the United States. It will be marketed under the brand name mRESVIA.
Supporters of the Moderna RSV vaccine argue that it signifies a substantial advancement in addressing RSV-related illnesses.
Despite the efficacy label indicating lower levels, they contend that the vaccine provides some protection and could alleviate the overall burden of RSV disease.
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