Moderna has secured approval from the US Food and Drug Administration (FDA) for its mRNA-based respiratory syncytial virus (RSV) vaccine mRESVIA (respiratory syncytial virus vaccine), for adults aged 60 and above.
The vaccine safeguards adults in this age group from lower respiratory tract disease (LRTD) caused due to RSV infection.
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The therapy designation marks the second mRNA product approval for the company.
mRESVIA (mRNA-1345) is the only RSV vaccine available in single-dose pre-filled syringes.
FDA approval comes after the successful Phase III ConquerRSV trial, which included 37,000 participants across 22 countries. The study showed an 83.7% efficacy in preventing LRTD caused by RSV.
The vaccine sustained protection over a median follow-up of 8.6 months. No serious safety issues were reported, with the most common adverse reactions being injection site pain and fatigue.
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By GlobalDataModerna CEO Stéphane Bancel stated: “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.
“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 maximise ease of administration, saving vaccinators’ time and reducing the risk of administrative errors.
“This approval is also the first time an mRNA vaccine has been approved for a disease other than Covid-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”
Moderna plans to make mRESVIA available for the 2024/2025 respiratory virus season in the US. It is also seeking approvals for mRNA-1345 in other global markets.
mRESVIA contains an mRNA sequence encoding a stabilised prefusion F glycoprotein, which is essential for viral entry into host cells.
In 2023, Moderna agreed to establish an mRNA manufacturing facility in Kenya.
The new advanced facility will have the capacity to produce up to 500 million vaccine doses annually.
