FDA approves World’s first RSV Vaccine

FDA approves World’s first RSV Vaccine | The Lifesciences Magazine

The initial RSV vaccine was given the go light by the Food and Drug Administration on Wednesday.

Results from the Trial

According to trial results, Arexvy, a novel vaccine created by GSK, formerly known as GlaxoSmithKline, was 82% effective in preventing lower respiratory tract illnesses brought on by RSV in persons 60 and older. Additionally, it had a 94% success rate in patients with at least one underlying medical condition.

Dr. Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research, said, “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

By the age of two, almost everyone has respiratory syncytial virus, which typically causes cold symptoms. However, it’s also the main reason why infants and young children are admitted to hospitals. The Centers for Disease Control and Prevention estimates that 58,000 to 80,000 children under 5 are hospitalized each year.

What is Arexvy? A look at the new, FDA-approved RSV vaccine

More Insights into the Vaccine

RSV also hits in later life, with older persons being hospitalized for more than 177,000 times a year and dying at a rate of 14,000 each year. The Guillain-Barré disease struck a 78-year-old lady in Japan around nine days after receiving the immunization, according to GSK researchers who presented their findings at an FDA advisory panel meeting in February.

The vaccination was nevertheless deemed safe and effective for older persons, according to the panel members, who decided to recommend it. According to the CDC, Guillain-Barré syndrome, also known as GBS, is a rare neurological condition in which the body’s immune system harms nerve cells, resulting in muscle weakness and occasionally paralysis. The National Institute of Neurological Disorders and Stroke estimates that 70% of persons with GBS recover fully. Although symptoms may last for years, most people recover within a few months, according to experts.

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