US drug regulator approves world’s first RSV vaccine

The US FDA has approved a vaccine called Arexvy by GSK for respiratory syncytial virus (RSV), which is responsible for killing thousands of Americans every year. The vaccine needs approval from the US Centers for Disease Control and Prevention before being made available to the public. The vaccine is expected to be available to people over 60 years old within a few months.

RSV is a respiratory illness that causes cold-like symptoms in adults but can be dangerous for young children, the elderly, and people with underlying health conditions. RSV kills around 100-300 children under five years old annually, and between 6,000 to 10,000 adults over 65 years old, leading to about 60,000 to 120,000 hospital admissions. Dr Peter Marks, who leads the Center for Biologics Evaluation and Research at the FDA, stated that the approval of the first RSV vaccine is a significant public health achievement in preventing a life-threatening disease.

RSV can cause bronchiolitis, a condition characterized by inflammation in the lungs, leading to breathing difficulties in severe cases. Arexvy, the vaccine developed by GSK, is the first vaccine to win approval to prevent RSV worldwide after over 60 years of development.

According to a study by GSK published in February, the vaccine has an efficacy rate of 82.6%. The side effects of the vaccine are mostly mild to moderate and last for up to two days. The most common side effects are pain around the injection site and fatigue.

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