Moderna has announced positive top-line data from a phase 3 trial of its investigational mRNA respiratory syncytial virus (RSV) vaccine – mRNA-1345 – for adults aged 60 years and older.
The ConquerRSV study met its primary efficacy endpoints, demonstrating that the vaccine offers 83.7% protection against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms, such as cough and fever.
The other primary efficacy endpoint against RSV-LRTD, defined by three or more symptoms, was also met, with a vaccine efficacy of 82.4%. The trial is ongoing, with additional efficacy analyses planned as cases arise, including for severe RSV.
Based on these results, Moderna said it intends to submit the vaccine for regulatory approval in the first half of this year. The company will also submit the data for peer-reviewed publication and present it at an upcoming scientific meeting.
Commenting on the positive results, Moderna’s chief executive officer, Stéphane Bancel, said: “This data is encouraging and represents the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after Spikevax, our COVID-19 vaccine.
RSV is a contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults.
In the US alone, it is estimated that RSV infections in older adults account for approximately 60,000 to 120,000 hospitalisations and 6,000 to 10,000 deaths each year. There is currently no vaccine for the virus in this age population.
Pfizer and GSK have also submitted applications for their respective RSV vaccines to the US Food and Drug Administration (FDA).
AstraZeneca and Sanofi’s antibody treatment Beyfortus (nirsevimab) received European Commission approval in November 2022 to prevent RSV in newborns and infants and is currently under review by the FDA.
Bancel said: “Respiratory diseases are a major public health priority, given they have a significant health impact and are a leading cause of hospitalisation.
“For these reasons, in addition to our mRNA-1345 RSV vaccine candidate, we are committed to developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease, including COVID-19, influenza and human metapneumovirus.”
Moderna is also developing a personalised cancer vaccine alongside Merck & Co – known as MSD outside the US and Canada – which has been shown to benefit patients with high-risk melanoma.