GlaxoSmithKline will seek approval for its respiratory syncytial virus vaccine for the elderly, after reporting data showing the vaccine is the first to work in the vulnerable age group for the major infectious disease.
The British drugmaker said on Friday that an interim analysis had shown statistically significant efficacy and no safety concerns for the vaccine.
Vaccine makers including GSK, Pfizer, Moderna and Johnson & Johnson are racing to find an RSV vaccine. The disease is common but can be severe in the elderly and infants, causing 360,000 hospitalizations and 24,000 deaths annually.
Hal Barron, scientific director of GSK, said the results suggested the vaccine offered “exceptional protection” to older people against the “serious consequences” of RSV infection.
“Given the importance of this data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022,” he said.
If approved, the vaccine will bolster GSK’s drug pipeline, which has come under intense scrutiny from investors including US hedge fund Elliott Management.
Despite being one of the world’s largest vaccine makers, GSK has yet to develop a Covid-19 vaccine from scratch, but has instead only supplied its adjuvant to boost efficacy. vaccines made by others, including Sanofi.
Elliott and other investors wondered if GSK chief executive Emma Walmsley could improve the pipeline, given her lack of scientific knowledge.
The announcement comes as the British company plans to spin off its consumer healthcare division in a London listing next month, to focus the remaining businesses on medicines and vaccines. GSK will receive a dividend of around £7 billion and will retain a stake in the business, which will be called Haleon, to sell over time, giving it more money to invest in R&D and potential transactions.
Pharmaceutical companies have sought to tackle RSV because it is one of the few major infectious diseases without a vaccine, in a market that analysts say could be worth up to $5 billion a year.
Janssen, the pharmaceutical division of Johnson & Johnson, and Pfizer both began phase 3 trials in September last year. In February, Moderna began its Phase 3 trial for an RSV vaccine, hoping to eventually create a vaccine that could prevent the disease, Covid-19 and the flu.
The success comes after GSK stopped a late-stage trial for an RSV vaccine in pregnant women in February and dropped an earlier trial for infants last year.