GlaxoSmithKline will apply for approval for its respiratory syncytial virus vaccine for older adults, after reporting data showing the shot is the first to work in the vulnerable age group for the major infectious disease.
The UK drugmaker said on Friday that an interim analysis showed statistically meaningful efficacy and no safety concerns for the vaccine.
Vaccine makers including GSK, Pfizer, Moderna and Johnson & Johnson, are racing to find a jab for RSV. The disease is common but can be severe in older adults and infants, causing 360,000 hospitalisations and 24,000 deaths a year.
Hal Barron, GSK’s chief scientific officer, said the results suggested the vaccine offered “exceptional protection” for older adults from the “serious consequences” of an RSV infection.
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“Given the importance of these 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 been under scrutiny from investors including US hedge fund Elliott Management.
Despite being one of the world’s largest vaccine makers, GSK has not yet developed a Covid-19 vaccine from scratch, but has instead only supplied its adjuvant to boost the efficacy of vaccines made by others, including Sanofi.
Elliott and other investors questioned whether GSK chief executive Emma Walmsley can improve the pipeline, given her lack of scientific background.
The announcement comes as the UK company is planning to spin off its consumer health division in a London listing next month to focus the remaining business on drugs and vaccines. GSK will receive a dividend of about £7 billion (€8.2 billion) and retain a stake in the business, to be named Haleon, to sell down over time, giving it more money to invest in R&D and potential deals.
Pharmaceutical groups have sought to address RSV because it is one of the few major infectious diseases without a vaccine, in a market that analysts estimate could be worth up to $5 billion (€4.7 billion) a year.
Janssen, the pharmaceuticals division of J&J, and Pfizer both started their phase three trials in September last year. In February, Moderna began its phase three trial for an RSV vaccine, hoping to ultimately create a jab that could prevent the disease, Covid-19 and influenza.
The success comes after GSK stopped a late stage trial for an RSV vaccine in pregnant women in February, and abandoned an earlier trial for infants last year.
- Copyright The Financial Times Limited 2022
