MORE VACCINES ON THE WAY
GSK’s vaccine contains a “subunit” or part of the virus to help train the immune system should it encounter the real thing.
It was approved based on a study of 25,000 people aged 60 and older that showed a single dose was 83 per cent effective against disease caused by RSV, and more than 94 per cent effective against severe disease.
Researchers will continue to follow volunteers in the study to assess the duration of protection as well as the safety and efficacy of more doses.
The most common side effects included injection site pain, fatigue, muscle pain, headaches and joint stiffness.
An irregular heartbeat was a less common side effect, occurring in 10 participants who received Arexvy and four participants who received placebo.
Safety issues were also found in two other studies of the drug involving approximately 2,500 people aged 60 and up. 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 other study, one participant developed Guillain-Barre syndrome, in which the immune system damages nerve cells, causing muscle weakness and sometimes paralysis.
GSK’s Arexvy was recommended for approval last week by the European Union’s drug watchdog, the European Medicines Agency, whose positive opinions are normally formally followed by approval from the European Commission.
Pfizer has said that it expects a decision from the FDA in May for its own RSV vaccine, also for those over 60 years old.
In January, Moderna said it hopes its RSV vaccine will be approved and available in time for the Northern Hemisphere’s winter later this year.
Several other companies are also developing RSV vaccines.
Last year, the EU approved a preventative antibody treatment against RSV, developed by British-Swedish pharmaceutical firm AstraZeneca and France’s Sanofi, which confers temporary protection.
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