Moderna’s mRNA-based vaccine against RSV (respiratory syncytial virus (sin-SISH-uhl)) was effective in preventing the disease in the elderly, according to preliminary and critical results of an ongoing Phase III clinical trial. The company announced Tuesday. Moderna said it will now seek regulatory approval for the vaccine in the first half of this year.
According to the company, the vaccine was 83.7 percent effective in preventing RSV-related lower respiratory tract disease (RSV-LRTD) involving two or more symptoms in adults age 60 and older. It was 82.4 percent effective in preventing RSV-LRTD with three or more symptoms in the same group. No safety concerns have been identified.
The results are another positive sign for mRNA vaccine platforms in general, which Moderna and other drug companies have quickly turned to to combat it. Various infections and other diseases Due to the worldwide success of mRNA-based COVID-19 vaccines. mRNA-based vaccines are now being developed for everything from the seasonal flu to HIV and some types of cancer.
RSV has been among the top priorities for vaccine development. Seasonal respiratory virus is potentially fatal for young children and the elderly. This was particularly noticeable in the past year, as RSV and other seasonal viruses caused unusually large waves of infections in the off-season in the wake of the turbulent spread of SARS-CoV-2. RSV typically sends about 3.6 million children worldwide to hospital each year and kills more than 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 sends about 60,000 to 120,000 to the hospital, killing 6,000 to 10,000.
Researchers have been working on an RSV vaccine for decades. in the 1960s, Tragedy struck an early vaccine trial, almost halting progress. It has only been in the past decade or so that researchers have been able to fully understand and overcome failure.
Now, with decades of foundational research, Moderna’s mRNA-based candidate is just one of many in the works. in August, Pfizer announced The protein-based RSV vaccine was 86 percent effective in older adults. Two months later, the company announced that its vaccine was 82% effective in preventing severe RSV in an infant’s first 3 months of life After vaccinating pregnant participants in the experiments. And in October, GSK announced that a protein-based RSV vaccine was on the way 83% effectiveness disease in the elderly.
For Moderna’s trial, the company enrolled nearly 37,000 adults 60 or older in 22 countries. The company reports that the interim analysis was based on 64 cases of RSV-LRTD with two or more presentations, of which 55 occurred in the placebo group. There were 20 cases of RSV-LRTD with three or more symptoms, of which 17 were observed in the placebo group.
“Today’s findings represent an important step forward in the prevention of lower respiratory disease due to respiratory syncytial virus in adults 60 years of age and older,” Stefan Bancel, our chief executive officer, said in a press release. “These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after Spikevax, our COVID-19 vaccine.” Bancel went on to say that the company will focus on preventing respiratory viruses, in particular, through its platform. In addition to the RSV vaccine candidate, “we are committed to developing a family of respiratory mRNA vaccines to target the most important viruses that cause respiratory diseases, including COVID-19, influenza, and human metapneumovirus.”