The vaccine demonstrated 83.7% efficacy in preventing RSV lower respiratory tract disease in adults aged 60 and older.
RT’s Three Key Takeaways:
- FDA Approval: The FDA has approved mRESVIA, an mRNA vaccine, for protecting adults aged 60 and older from lower respiratory tract disease caused by RSV infection, marking the first mRNA vaccine approved for a disease other than COVID-19.
- Clinical Efficacy: The approval is based on positive results from the phase 3 ConquerRSV trial, which included approximately 37,000 participants aged 60 and older across 22 countries. The trial demonstrated an 83.7% efficacy in preventing RSV lower respiratory tract disease.
- Safety and Availability: The phase 3 trial reported no serious safety concerns, with the most common side effects being injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna plans to have mRESVIA available for eligible US populations by the 2024/2025 respiratory virus season.
The US Food and Drug Administration (FDA) has approved mRESVIA, an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. mRESVIA is manufactured by Moderna ModernaTX, Inc.
“mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors,” says Stéphane Bancel, chief executive officer of Moderna, in a release. “This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”
Phase 3 Clinical Trial Data
The FDA’s approval of mRESVIA is based on positive data from the phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease of 83.7%. These results were published in The New England Journal of Medicine.
A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis and were included in the US package insert. An additional longer-term analysis showed continued protection against RSV lower respiratory tract disease over 8.6 months median follow-up.
No serious safety concerns were identified in the phase 3 trial. The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.
Moderna expects to have mRESVIA available for eligible populations in the US by the 2024/2025 respiratory virus season.
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