Moderna’s mRNA-based vaccine against RSV (respiratory syncytial (sin-SISH-uhl) virus) has shown positive results in older adults, according to preliminary topline results from an ongoing Phase III clinical trial the company announced Tuesday. was effective in preventing the disease of Moderna said it plans to seek regulatory approval for the vaccine in the first half of this year.
According to the company, the vaccine was 83.7% effective in preventing RSV-associated lower respiratory tract disease with 2 or more symptoms (RSV-LRTD) in adults aged 60 and older. In the same group he had 3 or more symptoms and the protective efficacy of RSV-LRTD was 82.4%. No safety concerns were identified.
Following the global success of its mRNA-based COVID-19 vaccine, the findings are another step forward for the mRNA vaccine platform that Moderna and other pharmaceutical companies have rapidly transitioned to combat a variety of other infections and diseases. One positive sign. mRNA-based vaccines are currently in development against everything from seasonal flu to HIV and certain cancers.
RSV is one of the top priorities for vaccine development. Seasonal respiratory viruses can be fatal not only to young children, but also to the elderly. This was particularly evident last year, as RSV and other seasonal viruses triggered an unusually large off-season wave of infections in the wake of the devastating spread of SARS-CoV-2. Typically, RSV sends about 3.6 million children to hospital worldwide each year, and he kills over 100,000 children under the age of five. to the Centers for Disease Control and Prevention. For the elderly in the United States, the virus causes approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths.
Researchers have been working on an RSV vaccine for decades. In the 1960s, tragedy struck early vaccine trials, effectively halting progress. It is only in the last decade or so that researchers have come to fully understand and overcome failure.
Decades of basic research now make Moderna’s mRNA-based candidate just one of many underway. In August, Pfizer announced that its protein-based RSV vaccine was about 86% effective in older people. Two months later, the company announced that it was 82% effective in preventing severe respiratory syncytial virus in infants three months of age after administering the vaccine to pregnant trial participants. In May, GSK announced that its protein-based RSV vaccine was approximately 83% effective against the disease in older adults.
In the Moderna trial, the company enrolled approximately 37,000 adults aged 60 and over in 22 countries. The interim analysis was based on 64 cases of RSV-LRTD with 2 or more symptoms, 55 of which occurred in the placebo group, the company reported.20 cases of RSV-LRTD with 3 or more symptoms. , 17 of which were observed in the placebo group.
“Today’s results represent an important step forward in preventing lower respiratory tract disease from RSV in adults 60 years and older,” said Stephan Bancel, CEO of Moderna, in a press release. It is promising and represents the second demonstration of positive Phase 3 trial results from our mRNA infectious disease vaccine platform, following our COVID-19 vaccine, Spikevax.” In addition to its RSV vaccine candidates, it said it would focus on the prevention of respiratory viruses in particular on its platform. We are working to develop a portfolio of organotypic mRNA vaccines.”
