Pfizer has said it will seek approval for a vaccine targeting respiratory syncytial virus (RSV) in older adults after reporting positive trial data as rival groups race to develop a jab for a market that analysts estimate will generate up to $10 billion of annual sales.
The US company on Thursday said a late-stage trial in adults aged 60 years and older demonstrated that its vaccine was safe and effective at preventing serious disease from the virus.
An application for regulatory approval will be submitted in the autumn, said Pfizer, which is hunting for new ways to boost revenues as sales of Covid-19 vaccines begin to moderate.
RSV is a contagious disease that can cause severe respiratory illness, particularly in older people and infants, where it is a common source of bronchiolitis. Each year about 336,000 older people are hospitalised worldwide because of RSV and there are 14,000 deaths a year in the US.
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The virus is one of the few major infectious diseases without a vaccine, although recent scientific advances have encouraged four large pharmaceutical companies — Pfizer, GSK, Johnson & Johnson and Moderna — to undertake late-stage trials of potential jabs.
GSK in June said it would apply for regulatory approval of its RSV vaccine for older adults following trial results that it said showed “statistically significant and clinically meaningful efficacy”.
J&J expects to publish late-stage clinical data for its vaccine in the coming months as does Moderna, which is aiming to develop a single “multivalent” jab that would protect against RSV, influenza and Covid-19.
Analysts say the revenues for a successful RSV jab would be significant, with SVB Leerink last year forecasting the market could eventually be worth up to $10 billion (€10 billion) a year.
Pfizer said its trial of 37,000 older adults demonstrated its vaccine was 85.7 per cent effective at preventing severe disease from lower respiratory tract RSV infection. The jab was well tolerated, with no safety concerns, it added.
Pfizer is also studying whether its shot can prevent RSV infection in infants from birth up to six months of age by vaccinating pregnant women. — Copyright The Financial Times Limited 2022
