San Francisco Frontiers - EU approves Moderna's RSV vaccine for over 60s

RSV is a highly contagious seasonal virus that can cause severe symptoms in infants and the elderly -- one in 20 of whom contract it each year in Europe, according to the European Centre for Disease Prevention and Control (ECDC).

In the European Union, Norway and United Kingdom, RSV leads to the hospitalisation of around 158,000 adults each year, as well as some 213,000 children under five, according to ECDC data.

"Vaccination saves lives," the EU's commissioner for health and food safety, Stella Kyriakides, said in a statement announcing the approval of Moderna's mResvia vaccine.

"We are determined to ensure that everyone has access to the protection that they need against serious diseases."

The authorisation, which follows a similar step by the US Food and Drug Administration in May, is based on a positive assessment by the European Medicines Agency (EMA) in June.

The EMA approved the use of mResvia for the prevention of lower respiratory tract disease (LRTD), which is caused by RSV, in adults of 60 and older.

The EU had previously approved two vaccines for protecting against RSV, manufactured by Pfizer and GSK.

GSK and Pfizer's vaccines rely on traditional technology: introducing a pathogen component to the immune system to trigger a response.

In contrast, Moderna's vaccine utilises cutting-edge messenger RNA (mRNA) technology, instructing the body to produce a unique protein that stimulates an immune response, teaching it to defend against the infection.

"This approval of the first mRNA vaccine against RSV clearly shows the importance of innovation when it comes to protecting the health of our citizens," Kyriakides said.

Stephane Bancel, Moderna's chief executive, said the commission's approval was "an important milestone for public health and highlights Moderna's mRNA leadership."

T.Rivera--SFF