US FDA approves Moderna's RSV vaccine

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.

The company has said mRNA vaccines, which teach the body to make specific proteins that the immune system can recognize and attack, have the potential to treat multiple diseases and be more effective than conventional shots.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stephane Bancel said in a statement.

Analysts on average forecast sales for Moderna’s RSV vaccine of $340 million in 2024, growing to $830.5 million next year, according to LSEG data.

A panel of advisers at the U.S. Center for Disease Control and Prevention (CDC) will vote next month on recommendations for the vaccine’s use and intended population.

Moderna says it expects the shot to be available to eligible patients in the U.S. by the autumn vaccination season.

A positive CDC decision from the agency will allow Moderna to compete later this year against GSK and Pfizer, which has badly lagged its British rival since both launched their RSV shots last year.

GSK’s Arexvy is currently approved in the U.S. for adults aged 60 and over. British drugmaker has applied to extend the approved age group to include adults aged 50-59.

Pfizer’s Abrysvo is approved for adults aged 60 and older, as well as women at 32 through 36 weeks of pregnancy in order to protect their infants at birth.

The company’s shares fell last February, after data showed faster declines in the efficacy of its RSV vaccine when compared to the GSK and Pfizer shots.