European drugs body backs Moderna jab

Europe’s drug regulator has backed Moderna’s novel vaccine for respiratory syncytial virus, the US pharmaceutical firm announced on Friday.

Moderna said the European Medicines Agency’s Committee for Medicinal Products for Human Use had adopted a "positive opinion" recommending the granting of marketing authorisation in the European Union for the vaccine, known as mRESVIA.

The opinion was based on positive data from phase 3 clinical trials, which featured 37,000 adults in 22 countries, Moderna added.

Moderna’s mRESVIA vaccine is intended to protect adults aged 60 and over from lower respiratory track disease caused by RSV infection. RSV is a highly contagious seasonal respiratory virus, and causes around 160,000 adult hospital admissions every year in the EU.

It was developed using Moderna’s mRNA platform, which was used in its blockbuster Covid vaccine.

Stephane Bancel, chief executive, said: “The positive opinion…highlights the innovation and adaptability of our mRNA platform.

“mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration.

“We look forward to the decision on an EU-wide marketing authorisation from the European Commission.”

As at 1330 BST, shares in Nasdaq-listed Moderna were up 2% in pre-market trading.