The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for the mRNA respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) to protect adults aged 60 years or older from lower respiratory tract disease caused by RSV infection.
RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It is a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults.
mResvia (Moderna Biotech) is an mRNA vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and helps it to enter and thus infect host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.
The CHMP’s decision was based on a phase 2/3 randomized placebo-controlled study that demonstrated the vaccine’s effectiveness in preventing lower respiratory tract disease in people older than 60 years.
It is the first mRNA vaccine targeting a pathogen other than SARS-CoV-2 to receive a positive opinion from the CHMP, the EMA said.
A final decision on whether to grant a marketing authorization for EU countries will be taken by the European Commission.
mRNA Vaccine for New SARS-CoV-2 Variant
At its June meeting, the CHMP also backed an update to the composition of the mRNA vaccine Comirnaty to target the new SARS-CoV-2 JN.1 variant.
The JN.1 variant is a descendant of BA.2.86 and has an additional mutation in the spike protein. The JN.1 SARS-CoV-2 variant has been the most widely circulating in the United States and globally, according to an update from the CDC earlier this year.
The revision of Comirnaty is in line with a recommendation issued by the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the JN.1 variant in EU countries during the 2024-2025 vaccination campaign. In April this year, the ETF said that targeting JN.1 would help to maintain the effectiveness of COVID-19 vaccines as SARS-CoV-2 continues to evolve.