FDA approves Moderna's RSV vaccine for seniors, the company's second-ever product

The Food and Drug Administration on Friday approved Moderna's vaccine for respiratory syncytial virus for adults ages 60 and above, the company's second-ever product to enter the U.S. market. 

The decision is a win for Moderna, which desperately needs another revenue source amid plunging demand for its Covid jab, its only commercially available product. 

The approval of Moderna's shot is based on a late-stage trial on older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.

Moderna's shot will be marketed under the brand name mRESVIA. It is the first messenger RNA vaccine to get approved for a disease other than Covid. The company's shot is also the only RSV vaccine to be available in a pre-filled syringe, which is designed to make it easier to administer to patients.

An advisory panel to the CDC will vote in June on recommendations for the use and intended population of Moderna's shot. The company expects an equal recommendation to existing RSV shots from GSK and Pfizer, Moderna executives said during an earnings call on May 1. 

A positive recommendation from the CDC would allow Moderna's vaccine to compete against GSK and Pfizer, which launched their respective shots in the U.S. last fall. Pfizer's vaccine has so far lagged behind GSK's, but both shots have so far recorded hundreds of millions in sales. 

Moderna's full-year 2024 sales guidance of roughly $4 billion includes revenue from its RSV vaccine. 

The approval demonstrates the versatility of Moderna's messenger RNA platform beyond treating Covid. The biotech company is using that technology to tackle a range of different diseases, including RSV, cancer and a highly contagious stomach bug known as norovirus. 

"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Moderna CEO Stéphane Bancel said in a release. "With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases."

The biotech company currently has more than 40 products in development, several of which are in late-stage trials. They include its combination shot targeting Covid and the flu, which could win approval as early as 2025.

Moderna is also developing a stand-alone flu shot, a personalized cancer vaccine with Merck and shots for latent viruses, among other products.

Moderna has said it expects to return to sales growth in 2025 and to break even by 2026, with the launch of new products. 

Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: Shares of the company are up more than 40% this year after falling nearly 45% in 2023. 

The FDA was initially slated to make a decision on Moderna's jab on May 12. The agency delayed the approval, citing internal "administrative constraints." 

A phase three trial on roughly 37,000 people showed that Moderna's vaccine was 83.7% effective at preventing at least two symptoms of RSV at around three months. New data from that study in February showed the shot's efficacy declined to 63% at 8.6 months. 

At the time, those results raised concerns among investors that the shot's efficacy declined faster than that of shots from GSK and Pfizer. Moderna in a statement said comparisons can't be made without head-to-head trials on shots.

The company added that its trial had different study populations, geographic locations and case definitions for RSV, among other differences. 

No significant safety concerns were identified in patients who took the shot in the trial. Most side effects were mild to moderate and included injection site pain, fatigue, headache, muscle pain and joint pain.