FDA Approves Moderna’s RSV Vaccine, Its Second Licensed Product
The Food and Drug Administration has given the green light to Moderna’s latest vaccine aimed at protecting older adults against respiratory syncytial virus (RSV). This marks the second licensed product for the company, following its successful Covid-19 vaccine, Spikevax.
Moderna’s RSV vaccine, known as mResvia, has been specifically approved for individuals aged 60 and above. Utilizing the same messenger RNA platform as its predecessor, mResvia has shown promising results in clinical trials.
In a pivotal Phase 3 trial involving nearly 37,000 participants across 22 countries, the vaccine demonstrated an impressive efficacy rate of 83.7% against lower respiratory tract disease caused by RSV. Subsequent analysis during the FDA review reaffirmed this efficacy at 78.7%, indicating sustained protection.
According to Moderna CEO Stéphane Bancel, the FDA’s approval of mResvia underscores the company’s commitment to innovation and the potential of mRNA technology in vaccine development.
The arrival of Moderna’s RSV vaccine comes on the heels of approvals for similar products from competitors such as GSK’s Arexvy and Pfizer’s Abrysvo, which target the same age group. Both GSK and Pfizer are now seeking extensions to market their vaccines to younger adults at high risk for severe RSV infection.
As the race to combat RSV intensifies, the approval of Moderna’s mResvia signals a significant advancement in the fight against respiratory illnesses in older populations.
Overall, the approval of Moderna’s RSV vaccine marks a pivotal moment in the ongoing battle against infectious diseases, showcasing the potential of mRNA technology in developing effective and timely vaccines.
By Helen Branswell, Senior Writer, Infectious Diseases. Follow her on Mastodon and Bluesky for more updates on outbreaks, research, and vaccine development.