COVID-19: Novavax vaccine progresses to late-stage trial

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US company Novavax has reported positive results from the Australian-based phase one trial of its investigative COVID-19 vaccine.

The trial was held at two Australian sites, in Brisbane and Melbourne, and involved healthy adults aged 18-59 years.

The company's recombinant COVID-19 vaccine candidate (NVX‑CoV2373) adjuvanted with Matrix-M.

The company said it was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server.

"Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly," said the company.

Novavax said NVX-CoV2373 induced neutralisation titers in 100 per cent of participants and all subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus-neutralising antibody responses. After Dose 2, 100 per cent of participants developed wild-type virus-neutralising antibody responses.

It said both anti-spike IgG and viral neutralisation responses compared favourably to responses from patients with clinically significant COVID‑19 disease.

"Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional," said the company.

“The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well-tolerated COVID-19 vaccine with a robust immunogenicity profile,” said Dr Gregory Glenn, president, Research and Development at Novavax.

“Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX‑CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID‑19 patients with clinically significant disease.”

The vaccine is being developed with direct financial support from the Coalition for Epidemic Preparedness Innovations (US$388 million) and the US government's 'operation warp speed' initiative (US$1.6 billion).