FDA approves Moderna’s mRNA RSV vaccine

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

The approval makes RSV the second disease for which an mRNA vaccine has been greenlighted. There are two other RSV vaccines approved for adults older than 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 older than 60 across 22 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 82.6 percent, respectively.

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

“Older adults, especially those with underlying health issues like heart or lung disease or compromised immune systems, are highly susceptible to severe illness from RSV,” an FDA spokesperson said in a statement to The Hill. 

“Today’s approval of mRESVIA for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older provides another available vaccine for the prevention of this potentially life-threatening disease and underscores the FDA’s ongoing commitment toward helping advance the development of safe and effective vaccines for use in the U.S.,” they added.

Updated at 1:51 p.m. June 4