This Phase 3 trial is being double-blinded with 37,000 people aged 60 and over in 22 countries, including the US. According to interim data, the potential messenger RNA vaccine showed almost 84% efficacy and was well tolerated. Of the 64 cases of patients with the virus showing two or more symptoms, 55 were in the placebo group versus 9 in the vaccinated group, the US lab says. The Boston-based biotech company is now set to apply for regulatory approval in several regions, including Europe, by mid-2023 for a potential winter 2023 market entry.
Bronchiolitis affects infants, but also the elderly
RSV is one of the viruses that causes bronchiolitis, a disease that mostly affects children. But it can also affect older people, for whom the vaccine is not marketed. Thus, among people aged 60 years and older in developed countries, about 5.2 million cases of the disease are registered annually, which leads to 500,000 hospitalizations per year.
Each year, the virus causes 30,000 deaths among elderly patients in rich countries, Dr. Paul Burton, Moderna’s medical director, told AFP: “This disease has a heavy toll that has been underestimated,” he continues. The number of potentially needed doses has yet to be determined. “A large proportion of RSV-related deaths occur in low-income countries where access to medical care is limited,” said Abdullah Baki, a professor at Johns Hopkins University and the lead author of the study.
The vaccine is currently in phase 1 clinical trials in children. Messenger RNA technology has proven to be key in the fight against the Covid-19 pandemic and is seen as promising in the fight against many other diseases.
Prophylactic treatment of bronchiolitis approved by the European Union
Moderna is not the only lab to take on the fight against RSV. In early November, the European Union approved a prophylactic treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Nirsevimab is not strictly speaking a vaccine, but acts with the same preventive purpose.
The American group Pfizer, for its part, recently announced positive trial results for a vaccine given to mothers during pregnancy that is designed to protect newborns from severe forms of bronchiolitis. Pfizer is also developing an RSV vaccine for people aged 60 and over, which is currently under review by US health authorities.