GSK Plc’s vaccine for respiratory syncytial virus won clearance from US regulators, giving the drugmaker an edge in its race against Pfizer Inc. as its product becomes the first shot approved to protect older adults from the lung disease.
(Bloomberg) — GSK Plc’s vaccine for respiratory syncytial virus won clearance from US regulators, giving the drugmaker an edge in its race against Pfizer Inc. as its product becomes the first shot approved to protect older adults from the lung disease.
The vaccine was authorized for people aged 60 and above by the US Food and Drug Administration, GSK said Wednesday. The UK drugmaker has touted the shot, called Arexvy to sound like RSV, as a potential blockbuster.
After scientists spent decades working on the virus without much success, RSV is emerging as a market attracting multiple pharma companies that could generate up to $10 billion in sales by 2032. GSK plans to introduce the vaccine ahead of the next viral season, which normally starts in the months leading up to winter.
The new vaccine could help GSK reassert its role as a key industry player after falling behind in Covid-19. The FDA clearance also gives the UK drugmaker a short lead time to push its product before Pfizer gains permission to sell a rival shot, a decision also expected in May.
As the two vaccines will compete directly, any guidance or restrictions from the FDA and its advisors may help determine which drugmaker is better positioned to grab a bigger market share. A Centers for Disease Control and Prevention panel will meet in June to discuss both shots and make recommendations.
RSV causes only mild respiratory symptoms in healthy adults and older children. But for the elderly and babies, it can trigger severe infection and become life-threatening.
This authorization “is an important public-health achievement,” Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The FDA’s decision was based on trial data from GSK that showed overall efficacy for the shot of 82.6%.
Big Pharma is also targeting prevention in younger patients. AstraZeneca Plc and Sanofi are expecting US authorization for their passive immunization using a long-acting antibody to protect newborns and infants in the third quarter. And Pfizer also aims to target pregnant women with its vaccine in 2023, which extends protection to their babies for about six months.
RSV circulates in the colder months of the year, causing more than 177,000 hospitalizations and 14,000 deaths in adults in the US, according to GSK.
Prior to splitting off its consumer business last year, GSK cited RSV among its major growth drivers for the standalone vaccines and pharma business, with sales potential of more than £3 billion ($3.7 billion) annually.
(Updates with more details on vaccine starting in second paragraph)
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