(Keep reading: Covid-19: there is a relationship between blood group A and an increased risk of infection)
“We are proud to announce these submissions for use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the United States. RSV is an important cause of lower respiratory tract infections in older adults and can place a significant burden on healthcare systems through hospitalizations and emergency care admissions,” said Stéphane Bancel, CEO of Moderna.
The trial met both efficacy endpoints, showing a vaccine efficacy (VE) of 83.7%.
(Also read: The serious increase in respiratory diseases in Bogotá in 2023)
The regulatory applications are based on positive data from a predetermined interim analysis of the ConquerRSV study, a randomized, double-blind, placebo-controlled trial that included approximately 37,000 adults aged 60 years and older in 22 countries.
The primary efficacy endpoints were based on two definitions of RSV-LRTD, which were determined as two or more symptoms or three or more symptoms of disease.
The trial met both efficacy endpoints, showing a vaccine efficacy (VE) of 83.7% against RSV-LRTD defined as two or more symptoms, and an VE of 82.4% against RSV-LRTD defined as three or more symptoms. The vaccine was well tolerated, presenting a favorable safety profile.
Most solicited adverse reactions were mild or moderate, with the most common in the mRNA-1345 group being injection site pain, fatigue, headache, myalgia, and arthralgia.
The ConquerRSV study is ongoing and additional efficacy analyzes are planned as more cases accumulate, including those of severe RSV. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled Phase 1 trial in pediatric populations.
In January 2023, the US FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults 60 years of age and older, and mRNA-1345 had previously received Breakthrough Therapy Designation for Fast Track by the FDA in August 2021. In Australia, the TGA submission will be reviewed under Priority Track, following the approval of the Priority Determination application for the mRNA-1345 vaccine in April 2023.
What is certain is that mRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNP) as in Moderna covid-19 vaccines.
(It may interest you: Classes are suspended due to an outbreak of respiratory viruses at the Santa Marta school)
The F glycoprotein is found on the surface of the virus and is required for infection as it helps the virus to enter host cells. It exists in two states, pre-fusion and post-fusion. The prefusion conformation is an important target of strong neutralizing antibodies, and the protein sequences are largely similar in the RSV-A and RSV-B subtypes.
