US becomes first country to approve respiratory syncytial virus vaccine

RSV is a common virus that usually causes mild, cold-like symptoms. (Representative)


The United States on Wednesday approved the world’s first vaccine for respiratory syncytial virus (RSV), the culmination of a decades-long hunt to protect vulnerable people from the common disease.

Drugmaker GSK’s ErxV was given the green light for adults 60 and older, with similar shots from other makers including Pfizer and Moderna expected to follow soon.

“Today’s approval of the first RSV vaccine is a significant public health achievement in preventing a disease that can be life-threatening,” Peter Marks, a senior US Food and Drug Administration (FDA) official, said in a statement.

“The decision marks a turning point in our effort to reduce the significant burden of RSV,” said Tony Wood, GSK’s chief scientific officer.

RSV is a common virus that usually causes mild, cold-like symptoms, but can be severe in infants and the elderly, as well as those with weakened immune systems and underlying conditions.

In severe cases it can lead to pneumonia and bronchiolitis, an inflammation of the small airways inside the lungs.

According to the US Centers for Disease Control and Prevention, RSV causes about 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults age 65 and older.

Awareness of the disease has grown in recent years, as it has put a strain on hospital systems over the past two winters.

RSV and flu rates fell during the Covid-19 lockdown, but when restrictions were lifted, young children were hit harder.

Pharmaceutical companies have been chasing an RSV vaccine for years. According to the report, given the recent breakthroughs in this area, analysts estimate that the market could exceed $10 billion in the next decade.

– More vaccines on the way –

GSK’s vaccine contains a “subunit,” or part of the virus, that helps train the immune system when it encounters the real thing.

It was approved based on a study of 25,000 people age 60 and older that showed a single dose was 83 percent effective against disease caused by RSV and more than 94 percent effective against severe disease. .

Researchers will continue to follow the volunteers in the study to assess the duration of protection as well as the safety and efficacy of higher doses.

The most common side effects include pain at the injection site, fatigue, muscle pain, headache, and joint stiffness.

An irregular heartbeat was a less common side effect, which occurred in 10 participants who received Erexvi and four participants who received placebo.

Safety issues were also found in two other studies of the drug, which included nearly 2,500 people age 60 and older. In one of these studies, two volunteers developed a rare type of inflammation that affects the brain and spinal cord, and one of them died.

In the second study, one participant developed Guillain-Barré syndrome, in which the immune system damages nerve cells, leading to muscle weakness and sometimes paralysis.

GSK’s Arexvy was last week recommended for approval by the European Medicines Agency, the European Union’s drug watchdog, whose positive opinion is usually formalized after approval from the European Commission.

Pfizer has said it expects a decision in May from the FDA on its own RSV vaccine, also for people over age 60.

Moderna said in January that it expected its RSV vaccine to be approved and available in time for the northern hemisphere winter later this year.

Several other companies are also developing RSV vaccines.

Last year, the European Union approved a preventive antibody treatment against RSV developed by British-Swedish pharmaceutical firm AstraZeneca and France’s Sanofi, which provides temporary protection.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)