The US health regulatory agency on Wednesday authorised the world's first respiratory syncytial virus (RSV) vaccine.
The Food and Drug Administration said that GlaxoSmithKline Biologicals' Arexvy vaccine can help protect people over 60 from RSV health risks.
"Older adults, in particular those with underlying health conditions such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV," Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research, said in a statement.
RSV is a common respiratory virus that can bring cold-like symptoms, but seriously threaten infants and elderly people.
The US Centres for Disease Control and Prevention says it causes as many as 80,000 hospital admissions for children younger than five each year.
It also causes up to 160,000 hospital admissions a year for people over 65.
RSV results in between 6,000 and 10,000 deaths a year in adults over 65, and 100 to 300 deaths in young children, according to the CDC.
The virus had a resurgence amid the Covid pandemic this winter. Hospitals in the UK and US saw a rise in cases in emergency rooms and paediatric health centres.
"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," Dr Marks said.
The FDA said that GSK's Arexvy vaccine was tested in a clinical study of 25,000 people over 60 years old.
The results found it was more than 82 per cent effective against the virus, and 94 per cent effective against severe disease from infection.
There are other RSV vaccines — made by Pfizer and Moderna — for which eventual approval is being sought.
