The frontrunners in a crowded race to develop the first vaccine for respiratory syncytial virus (RSV) — pharmaceutical giants Pfizer and GSK — will face scrutiny from a panel of U.S. experts this week.
The company’s shots could be the first approved vaccines for the virus, which leads to 3.4 million hospitalizations and 100,000 deaths worldwide each year, and could help the firms gain a foothold in a market estimated at $5 billion to $10 billion US, according to analysts.
The U.S. Food and Drug Administration (FDA) is scheduled to decide on approval of the vaccines for people aged 60 and above by May, and typically follows the recommendations of its independent panel of experts.
That would enable the shots to be rolled out ahead of a seasonal surge typical in the winter.
RSV infections can feel like a mild cold, but the virus is also one of the leading causes of more serious health conditions, including bronchiolitis and pneumonia, in young children. It has also confounded researchers since the search for a vaccine began in the 1960s, but increased understanding of RSV’s biology in recent years has led to the development of several shots.
Merck, Moderna, and Johnson & Johnson are also conducting trials of their own RSV vaccines.
High efficacy in trials
“RSV is the last of the great big respiratory viruses that afflict our population on an annual basis,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center.
Pfizer and GSK grabbed a lead last year after data from separate late-stage studies showed their shots prevented respiratory disease caused by RSV.
GSK’s vaccine was nearly 83 per cent effective in preventing lower respiratory tract disease in people aged 60 and over, and roughly 94 per cent effective in preventing severe disease.
Meanwhile, Pfizer’s vaccine was close to 67 per cent effective in preventing RSV-related lower respiratory tract illness with over two symptoms, and 86 per cent effective against illness marked by over three symptoms.
Schaffner expects a positive vote on the vaccines when the advisory panel discusses Pfizer’s vaccine on Tuesday, and GSK’s vaccine on Wednesday.
As for when the shots may be approved in Canada, there’s no clear timeframe just yet, though as one report suggests, Health Canada does tend to take longer to approve new products than its counterparts south of the border or in Europe.
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