Nikos Pekiaridis | Light rocket | fake images
The Food and Drug Administration on Friday approved modern Respiratory syncytial virus vaccine for adults 60 years and older, the company's second product to enter the U.S. market.
The decision is a victory for Moderna, which desperately needs another source of income amid falling demand for its Covid vaccine, its only commercially available product.
The approval of Moderna's vaccine is based on a late-stage trial in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 older people each year and causes between 60,000 and 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.
A CDC advisory panel will vote in June on recommendations for the use and intended population of Moderna's vaccine. The company expects a recommendation equal to existing RSV vaccines from GSK and PfizerModerna executives said during a May 1 earnings conference call.
A positive recommendation from the CDC would allow Moderna's vaccine to compete with 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 seen hundreds of millions in sales.
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 Covid treatment. The biotech company is using that technology to address a variety of different diseases, including RSV, cancer and a highly contagious stomach virus known as norovirus.
The biotech company currently has more than 40 products in development, several of which are in the late stages of testing. They include its combined Covid and flu vaccine, which could gain approval as early as 2025.
Moderna is also developing a standalone flu vaccine, 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 break even in 2026, with the launch of new products.
Investors have high hopes for the long-term potential of Moderna's mRNA product portfolio: The company's shares are up more than 60% this year after falling nearly 45% in 2023.
Vaccine trial data
The FDA was initially scheduled to make a decision on Moderna's vaccine on May 12. The agency delayed approval, citing internal “administrative limitations.”
A phase three trial in about 37,000 people showed that Moderna's vaccine was 83.7% effective in preventing at least two RSV symptoms in about three months. New data from that February study showed that the shot's effectiveness dropped to 63% at 8.6 months.
At the time, those results raised concerns among investors that the shot's effectiveness would decline faster than that of the GSK and Pfizer shots. Moderna in a statement said comparisons cannot be made without direct testing of the shots.
The company added that its trial had different study populations, geographic locations, and RSV case definitions, among other differences.
No major safety concerns were identified in patients who received the injection in the trial. Most side effects were mild to moderate and included injection site pain, fatigue, headache, muscle pain, and joint pain.
