AIFA green light for mRNA vaccine against RSV

The Italian subsidiary of Moderna, known as Moderna Italy, has announced that the Italian Medicines Agency (AIFA) has published in the Italian Official Journal ‘Gazzetta Ufficiale’ its marketing classification determination for mRNA-1345, an mRNA vaccine designed to protect adults aged 60 years and over from lower respiratory tract diseases caused by Respiratory Syncytial Virus (RSV) infection. AIFA’s authorisation is after the favourable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and the marketing authorisation issued by the European Commission (EC) on 22 August. This authorisation is valid in all 27 member states of the European Union, in addition to Iceland, Liechtenstein, and Norway. The approval of mRNA-1345 was predicated on the positive results obtained from the Phase 3 ConquerRSV clinical trial, a multinational study encompassing approximately 37,000 adults aged 60 and above, conducted in 22 countries worldwide. The primary analysis, with a median follow-up of 3.7 months, revealed that the vaccine efficacy (EV) was 83.7% (CI 95.88%: 66.0%, 92.2%) in preventing lower respiratory tract disease (LRTD) caused by RSV. These findings were subsequently published in The New England Journal of Medicine.