The FDA has approved Moderna’s RSV vaccine for older adults.
Courtesy: Modern
The Food and Drug Administration gave approval Friday Modernity Respiratory syncytial virus vaccine for adults age 60 and older, the company’s second-ever product to enter 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 vaccine is based on a late-stage trial in older adults, who are more susceptible to severe RSV cases. The virus kills between 6,000 and 10,000 seniors each year and results in 60,000 to 160,000 hospitalizations, according to the Centers for Disease Control and Prevention.
Moderna’s shot is marketed under the brand name mRESVIA. It is the first messenger RNA vaccine approved for a disease other than Covid. The company’s vaccine is also the only RSV vaccine available in a prefilled syringe designed to make it easier to administer to patients.
A CDC advisory panel will vote in June on recommendations for the use and intended population of the Moderna vaccine. The company expects an equivalent recommendation to existing RSV shots 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 seen hundreds of millions in sales so far.
Moderna’s full-year 2024 revenue forecast 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 uses this technology to combat a number of different diseases, including RSV, cancer and a highly contagious gastrointestinal pathogen called 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 press release. “With mRESVIA, we continue to impact patients by addressing global public health threats related to infectious diseases.”
The biotech company currently has more than 40 products in development, some of which are in late-stage testing. This includes the combination vaccination against Covid and the flu, which could be approved as early as 2025.
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Moderna is also developing, among other things, a stand-alone flu vaccination, a personalized cancer vaccine with Merck and vaccinations against latent viruses.
Moderna has said it expects to return to revenue growth in 2025 and reach breakeven 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 have risen more than 40% this year after falling nearly 45% in 2023.
Data on vaccination trials
The FDA was originally scheduled to make a decision on Moderna’s vaccine on May 12th. The agency delayed the approval, citing internal “administrative constraints.”
A Phase III trial involving about 37,000 people showed that Moderna’s vaccine was 83.7% effective in preventing at least two RSV symptoms after about three months. New data from that study in February showed the vaccine’s effectiveness fell to 63% after 8.6 months.
At the time, those results sparked concerns among investors that the vaccine’s effectiveness was fading faster than that of the GSK and Pfizer vaccines. Moderna said in a statement that comparisons were not possible without direct shot trials.
The company added that its study had, among other things, different study populations, geographic locations and case definitions for RSV.
No significant safety concerns were identified among patients who received the shot as part of the study. Most side effects were mild to moderate and included pain at the injection site, fatigue, headache, muscle pain and joint pain.
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2024-05-31 18:38:35
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