FDA approves Moderna’s mRNA RSV vaccine

May 31, 2024

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

The approval makes RSV the second disease for which an mRNA vaccine has been greenlighted. There are currently two other RSV vaccines approved for adults over 60: Arexvy by GSK and Abrysvo by Pfizer. Moderna’s mRESVIA is now the third shot added to the arsenal against RSV.

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

“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.”

According to Moderna’s announcement, the FDA approval was based off a multinational study involving around 37,000 adults over 60 across 22 different countries. The study found that mRESVIA had an efficacy against RSV lower respiratory tract disease of 83.7 percent.

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

The most common side effects reported from mRESVIA were injection site pain, fatigue, headache, muscle pain and join stiffness.