A vaccine from GlaxoSmithKline showed potential to protect adults aged 50 to 59 years from later-stage respiratory syncytial virus clinical trialthe company announced on Wednesday.
Initial trial results suggest that GSK’s vaccine, known as Arexvy, could help protect a wider population from RSV, a disease that causes thousands of hospitalizations and deaths in older Americans each year. Arexvy is currently approved in the US, Europe, Japan and other countries for adults 60 years of age and older.
A single dose of the British pharmacist’s vaccine produced an immune response in adults aged 50 to 59 who are at increased risk of getting RSV because of certain underlying medical conditions.
The immune response was no worse than that seen in adults aged 60 and over, GSK said in a statement. ONE previous test at last stage in this age group found that the shot was almost 83% effective in preventing lower respiratory tract disease caused by RSV.
Safety data in adults aged 50 to 59 were also consistent with data in adults aged 60 and over, according to GSK.
The drugmaker said it plans to present final results from the trial at an upcoming medical conference and submit them for publication in a peer-reviewed journal. GSK added that it is “on track” to become the first company to submit data on this age group to the Food and Drug Administration and other regulators and expects a decision on a possible label extension in 2024.
“We will submit these data for regulatory review as soon as possible with the aim of offering adults in this age group the option of a vaccine for the first time,” Tony Wood, GSK’s chief scientific officer, said in a statement.
Pfizer is the only other company with an approved RSV vaccine on the market. The company’s vaccine is approved for adults 60 and older and expectant mothers who can pass protection to their fetuses.
Pfizer did not immediately respond to a request for comment on whether it would present its own data for adults ages 50 to 59.
US health officials are counting on shots from Pfizer and GSK to help the country deal with this year’s RSV season. RSV and other respiratory viruses like the flu are already circulating, but so far at slower rates than this time last year, the Centers for Disease Control and Prevention said last week.
The US suffered an unusually severe RSV season last year. Cases of the virus in children and the elderly have overwhelmed hospitals across the country, largely because the public has stopped practicing Covid pandemic health measures that had helped keep the spread of RSV down.
RSV usually causes mild cold-like symptoms. But each year the virus kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to the CDC.
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