Last Update: May 04, 2023, 00:27 AM IST
RSV usually causes mild, cold-like symptoms, but can be severe for people with weakened immune systems. (Image/PTI)
This marks the first such approval globally, with similar vaccines from other manufacturers including Pfizer expected to follow soon.
The United States on Wednesday approved GSK’s Arexi vaccine against respiratory syncytial virus (RSV), which can cause severe pneumonia and bronchiolitis in infants and the elderly.
This marks the first such approval globally, with similar vaccines from other manufacturers including Pfizer 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 deadly,” Peter Marks, a senior official at the US Food and Drug Administration (FDA), said in a statement.
RSV usually causes mild, cold-like symptoms, but can be severe for people with weakened immune systems.
According to the US Centers for Disease Control and Prevention, it causes about 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults aged 65 and older.
The vaccine was approved for people age 60 and older based on a study of 25,000 people that showed a single dose was 83 percent effective against disease caused by RSV, and against severe disease. was more than 94 percent effective.
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 Erexy and 4 participants who received a placebo.
GSK’s Arexy has been recommended for approval by the European Medicines Agency, the European Union’s drug watchdog, whose positive opinion is formally followed up by the European Commission.
Pfizer has said it expects a decision from the FDA in May for its more than 60 RSV vaccines.
In January, Moderna said it expected its RSV vaccine to be approved and available for the Northern Hemisphere winter later this year.
Last year, the European Union approved a preventive antibody treatment against RSV developed by British-Swedish pharmaceutical firm AstraZeneca and France’s Sanofi.
read all Breaking News Here
(This story has not been edited by News18 staff and is published from a syndicated news agency feed)
