Last update: 04 May 2023, 00:27 HST
RSV normally causes mild, cold-like symptoms, but can be serious for people with weakened immune systems. (Image/PTI)
This is the first such approval in the world, with similar vaccines from other manufacturers, including Pfizer, expected to follow soon.
The United States on Wednesday approved GSK’s Arexy vaccine against respiratory syncytial virus (RSV), which can cause severe pneumonia and bronchiolitis in infants and the elderly.
It is the first such approval in the world, with similar vaccines from other manufacturers, including Pfizer, expected to follow soon.
“Today’s approval of the first RSV vaccine is an important public health step forward in preventing a potentially life-threatening disease,” said Peter Marks, senior Food and Drug Administration (FDA) official. ) of the United States, in a press release.
RSV normally causes mild, cold-like symptoms, but can be serious for people with weakened immune systems.
According to the US Centers for Disease Control and Prevention, it results in approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 and older.
The vaccine has been approved for people aged 60 and over, based on a study of 25,000 people which showed that a single dose was 83% effective against diseases caused by RSV and over 94% against serious diseases.
The most common side effects included pain at the injection site, fatigue, muscle aches, headaches, and joint stiffness.
An irregular heartbeat was a less common side effect, occurring in 10 participants who received Arexy and 4 participants who received a placebo.
GSK’s Arexy has been recommended for approval by the European Union’s medicines watchdog, the European Medicines Agency, whose positive opinions are normally formally followed by the European Commission.
Pfizer said it expects an FDA decision in May for its own RSV vaccine for over-60s.
In January, Moderna said it hoped its RSV vaccine would be approved and available for the Northern Hemisphere winter later this year.
Last year, the EU approved a preventive antibody treatment against RSV, developed by the British-Swedish pharmaceutical company AstraZeneca and the French Sanofi.
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(This story has not been edited by News18 staff and is published from a syndicated news agency feed)
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