FDA approves Moderna’s mRNA RSV vaccine

The Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults 60 years of age and older.

With this approval, RSV infection becomes the second disease for which an mRNA vaccine has been approved. There are currently two other RSV vaccines approved for adults aged 60 and over: GSK’s Arexvy and Pfizer’s Abrysvo. Moderna’s mRESVIA becomes the third additional vaccine against RSV.

“The FDA approval of our second product, mRESVIA, further reinforces the strength and versatility of our mRNA platform,” Moderna CEO Stephane Bancel said in a statement.

“mRESVIA protects older adults from the severe outcomes of RSV infection and is the only RSV vaccine available in a prefilled syringe designed to maximize ease of administration, saving vaccine recipients time and reducing the risk of administration errors.”

According to a Moderna statement, the FDA’s approval was based on a multinational study of approximately 37,000 adults aged 60 years or older across 22 countries. The study found that mRESVIA demonstrated 83.7 percent efficacy against respiratory syncytial virus lower respiratory tract disease.

This reported efficacy exceeds the vaccine efficacy rates reported for the Pfizer and GSK RSV vaccines, which were 77.8 percent and 74.6 percent, respectively.

The most commonly reported side effects with mRESVIA were pain at the injection site, fatigue, headache, muscle pain, and joint stiffness.