The GSK-RSV vaccine for older adults offers long-term safety
Viral vaccine against respiratory syncytial virus in research.
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GlaxoSmithKline announced on Wednesday that its vaccine to protect adults age 60 and older against respiratory syncytial virus (RSV) has remained effective through two seasons of the disease.
A single dose of the shot was 67.2% effective in preventing lower respiratory tract disease over two RSV seasons, according to new results from a phase III clinical trial. This compares to 82% after a virus season, which typically lasts from October to March in the northern hemisphere.
Vaccination was also 78.8% effective against severe RSV disease after two seasons compared to 94% after one season. Serious illness is defined as cases that make normal, daily activities impossible.
The London-based company said the high levels of effectiveness are maintained in older adults with underlying conditions, who are most at risk of serious RSV infection.
GSK also evaluated the effectiveness of an annual vaccination schedule that involves giving a second dose of its vaccine after one year. The company stated that the cumulative efficacy of two doses was 67.1%, “suggesting that revaccination at 12 months does not appear to add any additional benefit to the general population.”
That means the vaccine may only need to be given every two years, which could give GSK an edge over competitors like RSV vaccines Pfizer and make it easier for seniors to protect themselves from the virus.
RSV usually causes mild, cold-like symptoms. The virus kills between 6,000 and 10,000 seniors and a few hundred children under the age of 5 each year, according to the Centers for Disease Control and Prevention.
GSK presented the findings to a CDC advisory committee on Wednesday. The committee will develop a recommendation on when and how often to vaccinate the company’s RSV — and a competitor’s vaccine Pfizer – should be administered in the US
The Food and Drug Administration approved the GSK vaccine just last month, making it the world’s first approved vaccine against RSV.
Pfizer’s RSV shot was the second to be allowed shortly after. The company also presented new clinical trial data on its vaccine on Wednesday.
This vaccine was approximately 49% effective against lower respiratory tract disease with two or more symptoms at 18 months, a sharp decrease from the vaccine’s effectiveness of 66.7% at one year.
None of the drugmakers have set a list price for their vaccine.