The United States Food and Drug Administration (USFDA) has approved the world’s first vaccine against respiratory syncytial virus (RSV). The vaccine, Arexvy, is manufactured by GSK plc.
According to Pharma major, the vaccine is approved for the prevention of lower respiratory tract disease (LRTD) caused by the virus in individuals 60 years of age and older. According to reports, this is the first RSV vaccine for older adults to be approved anywhere in the world.
“Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries,” Tony Wood, Chief Scientific Officer, GSK, said in a statement.
According to media reports, the vaccine still needs approval from the US Centers for Disease Control and Prevention before the roll-out.
RSV is a common respiratory virus that generally causes mild, cold-like symptoms, as per CDC. Although most people recover quickly from this diseases, the infection can be fatal for infants and older adults.
According to CDC, RSV is the most common cause of bronchiolitis and pneumonia in children younger than 1 year of age in the United States. On average, it kills 100-300 children under the age of 5 in the US every year, according to the CDC.
Reportedly, the was over 60 years in the making. According to a study published by the pharma major in February, the efficacy of this vaccine is at 82.6 percent.
In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the US. The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.