An early-stage trial of a promising coronavirus vaccine found high levels of neutralising antibodies in Australians who volunteered to get the experimental injection.
The US Biotech company Novavax announced the results of the Phase 1 trial on Wednesday, flagging its intention to start large-scale Phase III trials as soon as September and manufacture up to two billion doses of the vaccine in 2021.
Australian microbiologist Dr Paul Griffin is helping to trial a vaccine he believes could guard against coronavirus.Credit:Justin McManus
Participants were given 5 microgram and 25 microgram doses of the vaccine, with and without the adjuvant. Novavax said it would likely move forward with the lower dose.
Among participants given two doses of the vaccine, roughly 80 per cent had pain and tenderness at the site of the injection. Overall, just over 60 per cent of participants had other side effects, the majority mild to moderate and most commonly headache, fatigue and muscle pain.
Eight trial participants experienced adverse side effects after receiving a second vaccine that was deemed "severe". None required hospitalisations. All side effects resolved in a few days.
Overall the vaccine was extremely well tolerated and had a very good safety profile, Dr Gregory Glenn said.
Dr Glenn said he hoped further trials of the vaccine would secure regulatory approvals as early as December.
The Novavax vaccine is among the first of a handful of programs singled out for US funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.
Novavax is yet to bring a vaccine to market but has advanced trials under way for vaccines to protect against Ebola, influenza and respiratory syncytial virus vaccines (the most common cause of respiratory and breathing infections in children).
Australian-based company Nucelus Network conducted the Phase 1 trial.
"The way we do that is not by exposing the volunteers to the virus in any way," said Nucleus Network Principal Investigator Dr Paul Griffin when the trial commenced in May.
"[Instead] we take blood tests from them and we test that in about half a dozen different ways, to show that this vaccine has hopefully provided the immune response that we need to protect people from COVID-19," Dr Griffin said.
The US government gave Novavax $US1.6 billion ($2.2b) to help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.
The Coalition for Epidemic Preparedness Innovations also tipped in $US388 million ($401m) to fund its development.
with Aisha Dow and Reuters
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