The FDA noted a higher incidence of atrial fibrillation (irregular heart rhythm) among vaccine recipients relative to the control group.
The studies found the side effects of the vaccine were limited.īut the most commonly reported side effects by people who received Arexvy were: People who received the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease (LRTD) by 82% and reduced the risk of developing severe RSV-associated LRTD by 94%.
There were approximately 12,500 participants that received the vaccine and 12,500 participants received a placebo. The FDA has now analysed data for a single dose of Arexvy from the first of the three RSV seasons of the study. Participants will remain in the study through three RSV seasons - three years - to assess the duration of effectiveness, and the safety and effectiveness of repeat vaccination. GSK's new vaccine for older adults helps train the immune system to recognise a protein on RSV's surface, and contains an ingredient that develops a stronger immune reaction.Ī clinical study of Arexvy will look at the safety and effectiveness of a single dose administered to individuals 60 years of age and older. However, scientists have now figured out a better way to develop these vaccines. There was a major setback in the 1960s after an experimental shot worsened infections in children. Why has it taken so long to come up with a vaccine? and internationally in individuals 60 years of age and older."ĭr Phil Dormitzer, GSK's senior vice president and global head of vaccines research and development, said the company is already manufacturing doses of the vaccine The firm also said the vaccine was "generally well tolerated with an acceptable safety profile".Īfter analysing the safety and effectiveness of the vaccine, the FDA said: "The safety and effectiveness of Arexvy is based on the FDA's analysis of data from an ongoing, randomised, placebo-controlled clinical study conducted in the U.S. against RSV-LRTD in adults aged 60 years and older". Pharmaceutical firm GSK said after its third trial, "the vaccine showed statistically significant and clinically meaningful overall efficacy. The FDA approved Arexvy for the prevention of lower respiratory tract disease caused by RSV in individuals who are 60 years of age and older. However, some people may experience a more severe RSV infection.
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