First attempt by British pharmaceutical giant GSK to approve a vaccine against respiratory syncytial virus (RSV) over 60s. As announced by the company itself, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion and now only a definitive green light is awaited from the European Commission. July. Respiratory syncytial virus, which causes bronchiolitis, causes 270,000 hospitalizations and approximately 20,000 hospital deaths in adults aged 60 and over each year in Europe.
To date, there is no vaccine available to prevent infection and its complications in this age group. CHMP’s decision is based on data from the phase III clinical trial of AReSVi-006, which showed an 82.6% vaccine efficacy in those in their 60s; In older adults with at least one underlying disease, such as cardiorespiratory or metabolic disease, efficacy was 94.6%.
According to the study, the vaccine was well tolerated with a generally acceptable safety profile, and the most common adverse events were injection site pain, fatigue, muscle and joint pain, and headache. The vaccine is also currently under review by other international regulatory authorities such as the US Food and Drug Administration, the Japanese Ministry of Health, Labor and Welfare, and some other regulatory agencies, with decisions expected in 2023. Reads a note from GSK.
The British lab isn’t the only one embarking on the fight against RSV. For example, the European Union approved a bronchiolitis preventive treatment jointly developed by AstraZeneca and Sanofi in late 2022. Nirsevimab, designed for infants, is not exactly a vaccine, but it works with the same preventive intent. Pfizer and Moderna are developing an RSV vaccine for the elderly that is currently under review.
Source: Today IT
Karen Clayton is a seasoned journalist and author at The Nation Update, with a focus on world news and current events. She has a background in international relations, which gives her a deep understanding of the political, economic and social factors that shape the global landscape. She writes about a wide range of topics, including conflicts, political upheavals, and economic trends, as well as humanitarian crisis and human rights issues.
