US approves first mRNA vaccine since Covid-19

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The US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“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 maximise ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than Covid-19.”

The approval is based on positive data from the Phase III clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries.

The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7%.

A follow-up analysis of the primary endpoint was performed during FDA review, and the results were consistent with the primary analysis. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.

mRESVIA consists of an mRNA sequence encoding a stabilised prefusion F glycoprotein. The prefusion conformation of the F protein is a significant target of potent neutralising antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna Covid-19 vaccines.

Diana Spencer, Senior Digital Content Editor, DDW

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