FDA Approves Moderna’s RSV mRNA Vaccine for Adults Over 60 

Image credits: thehill.com

United States—The Clinical and Post-Marketing Development of a vaccine is further enhanced with the FDA’s approval of Moderna’s RSV mRNA vaccine for adults over sixty years old. 

The approval places RSV as the second ailment for which an mRNA vaccine has been given clearance for administration. There are currently two other RSV vaccines approved for adults older than 60: The first and the second drugs are Arexvy, an anti-inflammatory drug produced by GlaxoSmithKline and Abrysvo, an antiplatelet drug produced by Pfizer. RSV and the fourth for Moderna as its mRESVIA is the third shot in the series, as reported by The Hills. 

“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.” 

Clinical Trial Success 

Employing a multinational trial with roughly 37,000 adults aged 18 years and above in 22 nations, the FDA approval was heralded by Moderna. On the efficacy of mRESVIA in RSV lower respiratory tract disease, the study revealed that its efficacy was only at 83.7 percent. 

Adverse Events and Safety Profile 

This reported efficacy is higher than the efficacy rates of Pfizer and GSK’s RSV vaccines, which are 77.8 percent and 74.6 percent, respectively. 

The tabulated adverse events reported from the administration of mRESVIA included injection site pain, fatigue, headache, muscle aches, and joint stiffness.