The TGA has granted a priority review to the mRNA-1345 vaccine for people over age 60.
The TGA has fast-tracked a review of the mRNA-1345 vaccine against respiratory syncytial virus (RSV) in adults 60 years and older.
Moderna announced the news, saying the potential vaccine was deemed vital and lifesaving. With a 150 working day turnaround expected, mRNA-1345 aims to be registered up to three months earlier than via the traditional route.
The manufacturer said that mRNA-1345 uses the same lipid nanoparticles as in their covid vaccines. It consists of a single mRNA sequence which encodes for a stabilized perfusion F glycoprotein, which is on the surface of the virus and is required to enter the host cells.
The ConquerRSV study in January of this year of around 37,000 adults in 22 countries was a phase III, randomised, double-blind, placebo-controlled study of adults 60 years of older. Review by an independent Data and Safety Monitoring Board identified no significant safety concerns and concluded that the efficacy of the mRNA-1345 vaccine was 83.7%.
The vaccine is currently also in phase one paediatric trials. Clinical trials are underway for combination vaccines against significant viruses causing respiratory disease including RSV, SARS-CoV-2 and influenza.
Morbidity and mortality due to RSV is comparable to that of influenza and represents a serious threat, particularly to children, older adults, and the immunocompromised. RSV infection can be debilitating and life-threatening, yet there are no licensed vaccines available anywhere in the world.
Diagnosis and awareness of RSV has been increasing in Australia, first becoming a notifiable disease in September 2022. Cases are more common in children, with 63,000 hospitalisations between 2006-2015, but RSV-related deaths are more numerous in adults, with 59% occurring in those aged 65 or above.
