The Arexy vaccine from GSK against Respiratory Syncytial Virus (RSV), which may cause serious pneumonia and bronchiolitis in young children and the elderly, received approval from the United States on Wednesday.
It is the first such clearance on a worldwide scale, and Pfizer and other manufacturers are anticipated to release comparable vaccines in the near future.
According to top US Food and Drug Administration (FDA) official Peter Marks, “today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”
RSV often only produces minor, cold-like symptoms, but in persons with weakened immune systems, it may be life-threatening.
The US Centers for Disease Control and Prevention estimate that it causes 60,000 to 120,000 hospital admissions and 6,000 to 10,000 fatalities among those 65 and older.
Based on a 25,000-person research that shown a single dose of the vaccine was 83 percent effective against RSV sickness and more than 94 percent effective against severe disease, the vaccine was authorized for use in persons 60 and older.
The most frequent adverse effects were joint stiffness, muscular soreness, headaches, and pain at the injection site.
Less often, 10 subjects who took Arexy and 4 persons who received a placebo had an abnormal heartbeat.
The European Medicines Agency, which oversees medicines for the European Union and whose recommendations are often officially adopted by the European Commission, has recommended that GSK’s Arexy be approved.
According to Pfizer, a decision from the FDA on its own over-60s RSV vaccine is anticipated in May.
Moderna expressed anticipation in January that their RSV vaccine will be authorized and accessible for the next winter in the Northern Hemisphere.
A prophylactic antibody therapy for RSV was licensed by the EU last year and was created by the British-Swedish pharmaceutical company AstraZeneca and the French company Sanofi.
