The Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults over 60.
The approval makes RSV the second disease for which an mRNA vaccine has been given the green light. There are currently two other RSV vaccines approved for adults over 60: GSK’s Arexvy and Pfizer’s Abrysvo. Moderna’s mRESVIA is now the third dose 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 serious outcomes of RSV infection and 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 on a multinational study involving nearly 37,000 adults over the age of 60 in 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% and 74.6%, respectively.
The most common side effects reported with mRESVIA were pain at the injection site, fatigue, headache, muscle pain, and joint stiffness.
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