This article deals with the first respiratory syncytial virus (RSV) vaccine approved by the FDA Medical Device Regulation. Arexvy is the first respiratory syncytial virus (RSV) vaccine that the FDA Medical Device Regulation has licensed for use in the country. Arexvy is approved to treat people 60 years of age and older for the prevention of lower respiratory tract illnesses brought on by RSV.
RSV is a very contagious virus that infects the lungs and respiratory systems of people of all ages and its circulation often has a seasonal pattern that starts in the fall and peaks in the winter. This virus frequently contributes to lower respiratory tract disease (LRTD), a lung disorder that can cause bronchiolitis (inflammation of the small airways in the lungs) and potentially fatal pneumonia in elderly people. The U.S. Centers for Disease Control and Prevention estimate that RSV causes between 60,000 and 120,000 hospitalizations and 6,000 and 10,000 fatalities among persons 65 and over each year in the U.S.
Based on the FDA’s examination of data from ongoing, randomized, placebo-controlled clinical research in people 60 years of age and older carried out in the U.S. and abroad, Arexvy has been shown to be safe and effective. Arexvy’s primary clinical research was created to evaluate the efficacy and safety of a single dosage given to people 60 years of age and older. Before participants are removed from the experiment, three RSV seasons will have passed in order to assess the durability of efficacy as well as the advantages of recurrent vaccination. The FDA’s analysis was allowed to use data for a single Arexvy dosage from the study’s first RSV season. To know more about Arexvy, click here – FDA Approves First Respiratory Syncytial Virus
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Source: FDA Approves First Respiratory Syncytial Virus
