GSK's Arexvy: FDA Approves Historic RSV Vaccine for Adults Aged 60+

The Food and Drug Administration has given the green light to GSK's respiratory syncytial virus (RSV) vaccine, marking a significant advancement after scientists first tried to create a vaccine for the virus nearly 60 years ago.

The RSV vaccine, a single-dose injection intended for persons 60 and older, decreased the probability of symptomatic disease by 83% and severe illness by 94% in a late-stage clinical study.

The vaccine manufactured by GSK still has to be approved by the Centers for Disease Control and Prevention (CDC) before it can be made accessible to the general public, and an advisory group is due to meet in June to talk about its use, per NBC News.

RSV is a serious illness that may kill people of any age. In the US, it is estimated that 159,000 people 65 and over are hospitalized each year with RSV, causing 10,000 to 13,000 fatalities.

For older people, particularly those with underlying medical issues like heart or lung disease or compromised immune systems, RSV presents a significant risk of a severe infection.

According to Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, the FDA's clearance of the first RSV vaccine in the world is a noteworthy development in public health since it helps to avoid a condition that might be fatal and shows the agency's continued dedication to promoting the "development of safe and effective vaccines" in the United States, as per a CNN report.

How Safe Is The GSK-Made Vaccine?

GSK researchers presented a few examples of neurological diseases that followed immunization at an FDA advisory panel meeting in February, including a case of Guillain-Barré syndrome in a 78-year-old lady in Japan approximately nine days after getting the injection, according to USA Today.

Despite these reports, panelists still advocated for the vaccination because they believed it to be safe and effective for older adults.

According to the CDC, Guillain-Barré syndrome is a rare neurological condition that causes muscle weakness and, in some instances, paralysis when the immune system attacks nerve cells.

The National Institute of Neurological Disorders and Stroke stated that around 70% of persons with GBS attain complete recovery.