After 20 years of work, global researchers are just one step away from releasing a breakthrough vaccine targeting RSV, the world’s second leading cause of infant mortality after the first month of life.
The announcement, published August 8th in The Lancet Infectious Diseases, means that a long-lasting monoclonal antibody treatment for infants could be brought to Western markets within 12 months, followed closely by the approval of a maternal vaccine to provide newborns with protection against the virus.
RSV infects the lungs and can lead to life-threatening complications such as bronchiolitis and pneumonia, and globally, it is responsible for the deaths of more than 100,000 children each year in low and middle-income nations, as well as some 3.6 million hospitalisations.
Recent modelling also suggests that RSV has a similar disease burden to seasonal influenza in adults over the age of 65 years.
The review, Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape, was written in conjunction with researchers from the Telethon Kids Institute, UNSW Sydney and UWA, with the Telethon Kids Institute one of the lead sites contributing to the development of the maternal vaccine.
Professor Peter Richmond, Head of Paediatrics at UWA and Head of the Vaccine Trials Group at the Wesfarmers Centre of Vaccines and Infectious Diseases, said the team from the Institute are now in the final stages of development for several preventative antibody treatments and RSV vaccines.
“Observations from multiple studies conducted worldwide have shown there are nine potential candidates in Phase 3 clinical trials –the final stage prior to licensing for use – including two antibody immunisation treatments for prevention in babies and two maternal vaccines designed to be given to pregnant mothers,” Professor Richmond said.
“This is an especially exciting time for us – we started our first Phase 1 and 2 studies looking at RSV vaccines all the way back in 2000 and it has been a long journey to get to this point.”
Professor Richmond explained that several of the early studies were unsuccessful and ceased in the development stages, but in 2016 the team began to see positive results for a Phase 2 study looking at a monoclonal antibody treatment called Nirsevimab.
“We recently completed Phase 3 studies on Nirsevimab here in Perth, and there have been positive results reported from the northern hemisphere pre-COVID-19, so it is expected to be licensed for use as the very first RSV prevention treatment in the USA/Europe by late 2022 or early 2023,” he said.
“This week we began a Phase 3 study on the second potential antibody treatment, which hopes to provide long-lasting protection for babies at highest risk of being hospitalised with RSV, including those born prematurely, or those with congenital heart disease or chronic lung disease.
“I am very keen to make the most of this opportunity here in Australia, as I believe the potential burden of disease, we may be able to prevent will be even greater than first thought, including decreasing the amount of antibiotics that are prescribed, reducing ear infections in young babies, and decreasing more serious bacterial pneumonias that are associated with RSV infection,” Professor Richmond explained.
“In the next 10 years I hope to see licensed vaccines and preventative drugs being given to mothers, babies, toddlers, and older adults, with multiple vaccine and monoclonal antibody platforms available that could even be combined with COVID and influenza vaccines, keeping our hospitals and GP surgeries much quieter overwinter.”