Medicine watchdog EMA approves the first vaccine against the respiratory syncytial virus (RS virus) for people aged 60 and older.
A previous large international randomized placebo-controlled study showed that the vaccine provides protection against an RS virus infection in 83 percent of people and that protection remains high for at least six months. The most common side effects, such as headache and muscle pain, are usually mild and disappear after a few days.
Based on this research, the EMA has approved the RS vaccine (vaccine Arexvy, GSK) for people aged 60 and over, according to a recent press release from the drug watchdog. This makes this the first RS vaccine available for this target group. In general, the European Commission adopts sound recommendations from the EMA. A final decision is expected in July.
Arexvy targets the RSV fusion (F) glycoprotein, the Achilles’ heel of the virus. It elicits antibodies that target the prefusion form of this protein. Those antibodies are more efficient at neutralizing the RS virus than the antibodies that target the postfusion form.
The approval went through an accelerated process (accelerated assessment). In Europe, the virus causes approximately 250,000 hospital admissions and 17,000 deaths among people over the age of 65 each year.
Research is currently ongoing into, among other things, the effectiveness of one vaccine dose over several seasons and the need for a subsequent vaccination. In addition, other pharmaceutical companies also have RS vaccines in the pipeline.