FDA approves Moderna RSV vaccine for seniors

The FDA has approved Moderna’s RSV vaccine for older adults.

Courtesy: Moderna

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

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

The approval of Moderna’s shot relies on a late-stage trial on older adults, who’re more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every 12 months and leads to 60,000 to 160,000 hospitalizations, in keeping with data from the Centers for Disease Control and Prevention.

Moderna’s shot shall be marketed under the brand name mRESVIA. It’s the primary messenger RNA vaccine to get approved for a disease aside from Covid. The corporate’s shot can also be the one RSV vaccine to be available in a pre-filled syringe, which is designed to make it easier to manage 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 corporate expects an equal advice to existing RSV shots from GSK and Pfizer, Moderna executives said during an earnings call on May 1. 

A positive advice from the CDC would allow Moderna’s vaccine to compete against GSK and Pfizer, which launched their respective shots within the U.S. last fall. Pfizer’s vaccine has thus far lagged behind GSK’s, but each shots have thus far recorded a whole lot of thousands and thousands in sales. 

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

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

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

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

Moderna can also be developing a stand-alone flu shot, a customized cancer vaccine with Merck and shots for latent viruses, amongst other products.

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

Investors have high hopes for the long-term potential of Moderna’s mRNA product pipeline: Shares of the corporate are up greater than 60% this 12 months after falling nearly 45% in 2023. 

Vaccine trial data

The FDA was initially slated to make a call 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 stopping at the least two symptoms of RSV at around three months. Recent data from that study in February showed the shot’s efficacy declined to 63% at 8.6 months. 

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

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

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