The FDA has approved Moderna’s RSV vaccine for older adults.
Courtesy: modern
The U.S. Food and Drug Administration approved it Friday modern The respiratory syncytial virus vaccine for adults over 60 years old is the company’s second product to enter the U.S. market.
The decision is a win for Moderna, which desperately needs another revenue stream as demand for its coronavirus vaccine, its only commercial product, plummets.
Moderna’s shot gets approval based on late stage trial For older people, they are more susceptible to severe cases of RSV. According to statistics, the virus kills 6,000 to 10,000 older adults each year and causes 60,000 to 160,000 hospitalizations. Data from Centers for Disease Control and Prevention.
Moderna’s vaccine will be sold under the brand name mRESVIA. This is the first messenger RNA vaccine approved to treat a disease other than COVID-19. The company’s vaccine is also the only RSV vaccine that comes in a prefilled syringe, designed to make it easier for patients to administer it.
one advisory group The CDC will vote in June on recommendations for use and target groups of the Moderna vaccine. Company hopes to get recommendations on par with existing RSV vaccine GSK and PfizerModerna executives said during an earnings call on May 1.
The CDC’s positive recommendation would put Moderna’s vaccine in competition with GlaxoSmithKline and Pfizer, which launched their respective vaccines in the U.S. last fall. Pfizer’s vaccine has so far lagged behind GlaxoSmithKline’s, but both vaccines have so far sold hundreds of millions of dollars.
Moderna’s full-year 2024 sales guidance is about $4 billion, which includes revenue from its RSV vaccine.
This approval demonstrates the versatility of Moderna’s messenger RNA platform beyond treating COVID-19. The biotech company is using the technology to tackle a range of different diseases, including respiratory syncytial virus, cancer and a highly contagious stomach bug called norovirus.
“The FDA’s 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. “Through mRESVIA, we will continue to serve patients. , addressing global public health threats related to infectious diseases.”
The biotech company currently has more than 40 products in development, including some in late-stage trials. These include a combination vaccine against COVID-19 and influenza, which could be approved as soon as 2025.
Moderna is also developing products such as a standalone flu vaccine, a personalized cancer vaccine in partnership with Merck and a vaccine against latent viruses.
Moderna said it expects to resume sales growth in 2025 and achieve breakeven in 2026 as new products are launched.
Investors have high hopes for the long-term potential of Moderna’s mRNA product line: 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. Approval was delayed due to internal “administrative restrictions”.
A Phase 3 trial A study of about 37,000 people showed the Moderna vaccine was 83.7% effective in preventing at least two RSV symptoms for about three months. new data The February study showed that the shot’s efficacy dropped to 63% at 8.6 months.
At the time, the results raised concerns among investors that the vaccine’s effectiveness was declining faster than those from GlaxoSmithKline and Pfizer. modern in a statement Without head-to-head testing of the lenses, he said, comparisons can’t be made.
The company added that its trials had differences such as different study populations, geographic locations and RSV case definitions.
No major safety concerns were identified among patients who received the injection in the trial. Most side effects are mild to moderate and include injection site pain, fatigue, headache, muscle pain, and joint pain.
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