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The Food and Drug Administration granted approval on Friday Modernas respiratory syncytial virus vaccine for adults 60 years and older, the company's second product ever to hit the U.S. market.
The decision is a victory for Moderna, which desperately needs another source of revenue amid falling demand for its Covid shot, its only commercially available product.
The approval of Moderna's shot is based on a late stage process in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and leads 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 be approved for a disease other than Covid. The company's shot is also the only RSV vaccine available in a prefilled syringe, which is designed to make it easier to administer to patients.
A advisory committee to the CDC will vote in June on recommendations for the use and target population of Moderna's shot. The company expects an equivalent recommendation to existing RSV recordings GSK And PfizerModerna executives said this during a May 1 earnings call.
A positive recommendation from the CDC would allow the Moderna vaccine to compete with GSK and Pfizer, which launched their respective shots in the US last fall. Pfizer's vaccine has so far lagged GSK's, but both shots have generated hundreds of millions in sales so far.
Moderna's full-year 2024 sales guidance of about $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 disease known as norovirus.
“The FDA approval of our second product, mRESVIA, builds on the power and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in a press release. “With mRESVIA, we continue to deliver results for patients by addressing the global public health threats associated with infectious diseases.”
The biotech company currently has more than 40 products in development, several of which are in advanced testing phases. This includes the combination shot against Covid and the flu, which could receive approval as early as 2025.
Moderna is also developing a standalone flu shot, a personalized cancer vaccine and injections against latent viruses, together with Merck.
Moderna has said it expects to return to sales growth in 2025 and break even with new product launches by 2026.
Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: The company's shares are up more than 60% this year, after falling nearly 45% in 2023.
Vaccine trial data
The FDA was initially expected to make a decision on Moderna's shot on May 12. The desk postponed approval, citing internal “administrative constraints.”
a phase three trial in about 37,000 people, Moderna's vaccine was found to be 83.7% effective in preventing at least two symptoms of RSV after about three months. New facts That study in February found that the injection's effectiveness had declined to 63% after 8.6 months.
At the time, these results raised concerns among investors that the shot's efficacy was declining faster than that of shots from GSK and Pfizer. Moderna in one rack said that comparisons cannot be made without head-to-head testing of shots.
The company added that its trial had different study populations, geographic locations and case definitions for RSV, among other things.
No significant safety issues were identified in patients who took the injection during the trial. Most side effects were mild to moderate and included injection site pain, fatigue, headache, muscle pain and joint pain.
