Biotech giant Moderna will submit data on a new vaccine for respiratory syncytial virus (RSV) to the Therapeutic Goods Administration this year in hopes of getting a product approved for older Australians as soon as 2024.
The $US73.2 billion ($104.8 billion) global vaccine maker revealed on Wednesday morning that a phase 3 trial for its vaccine against the respiratory disease showed it was 83.7 per cent effective in preventing at least two symptoms of the virus in older adults aged over 60.
RSV is a seasonal virus that can cause coughing, congestion and a sore throat, but can also lead to serious illness in infants and older adults. It was first identified in the mid-1950s, and researchers have been working on a vaccine for the product ever since.
Cases of RSV climbed during the winter months last year, with the virus responsible for more paediatric admissions to Victorian hospitals than COVID-19 or the flu last July.
Moderna’s chief medical officer Dr Paul Burton told this masthead that the company was now finalising its data on the vaccine for older adults to submit the product for approval to regulators.
“We would hope that we would have approvals really by the end of 2023 into early ’24, for that Northern Hemisphere season, and then obviously, be ready for the subsequent Southern Hemisphere winter in 2024,” he said.
The company is also running trials of an RSV product for infants, toddlers and pregnant mothers. Burton said the strength of the data from the older adults trial is a good sign for the possible future use of the vaccine by other groups.
“I would be cautiously optimistic that we’ll see equally good, strong effectiveness and efficacy results in those other groups of people,” he said.
The vaccine could eventually be made in Australia at Moderna’s mRNA vaccine manufacturing plant in Melbourne, which the company is building with a view of providing a range of respiratory disease products beyond its current COVID-19 vaccine.
The company is also working on developing a range of combination vaccines, which could fight influenza, COVID-19 and RSV within a single shot.
Burton said Moderna had the capability and technology to bring multiple vaccine products into one dose and that this idea wasn’t too far away.
“I would be confident that by the middle of this decade, we could absolutely have those combination vaccines tested and potentially available to people,” he said.
The possibility of combination vaccines could be a challenge to biotech incumbents like CSL, which has long been a major supplier of influenza vaccines globally.
CSL is also investing in new vaccine technology, however, including inking a licensing deal last year for a range of next-generation mRNA vaccines developed by US biotech Arcturus.
While Moderna’s new vaccine has not yet secured approvals, Burton said he believed the Australian government would be keen to secure orders of doses.
“I think this would indeed be an important vaccine for Australia, it’s also been through a particularly bad RSV season, as we are right now up here in the Northern Hemisphere,” he said. “I would imagine that they would be eager to talk to us about this.”
Health Minister Mark Butler has been contacted for comment.
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Source: Thanks smh.com