The US Food and Drug Administration (FDA) has approved Moderna's mRNA Respiratory Syncytial Virus (RSV) vaccine, mResvia, for older adults. This marks the second product from Moderna to receive FDA approval after its Covid-19 vaccine. The RSV vaccine is designed to protect against lower respiratory tract disease caused by RSV infection in adults aged 60 and above.
Moderna plans to launch mResvia in time for the upcoming 2024-2025 RSV season, which typically starts in late fall. The company's vaccine had an 83.7% efficacy rate against RSV-associated lower respiratory tract disease after nearly four months of median follow-up.
The FDA approval comes as the US grapples with a growing number of cases and hospitalizations due to RSV infection, particularly among older adults. The virus can cause symptoms such as a runny nose, cough, fever, sneezing, wheezing and decreased appetite. In severe cases, it can lead to pneumonia or worsen underlying respiratory conditions like asthma or chronic obstructive pulmonary disease (COPD).
Moderna's mResvia will join two other RSV vaccines for older adults that have already received FDA approval: GlaxoSmithKline's Arexvy and Pfizer's Abrysvo. All three vaccines are expected to be crucial tools in protecting older adults during the upcoming RSV season.
The approval of Moderna's mResvia is a significant milestone for the company, which has faced a sharp revenue downturn since the COVID-19 pandemic began to ease. The vaccine is based on Moderna's messenger RNA platform and marks its second FDA approval after Spikevax, its Covid-19 vaccine.
Moderna is also testing mRNA candidates against influenza, HIV, Lyme disease, Zika and many other diseases.