Shares in Novavax jumped after the company reported that its coronavirus vaccine candidate NVX-CoV2373 induced immune responses in an early-stage clinical trial.
The results come from the phase 1 portion of Novavax’ phase 1/2 clinical trial, which evaluated the vaccine at two dose levels – 5µg and 25µg – with and without an adjuvant in 131 healthy adults between the ages of 18 and 59 years.
According to Novavax, NVX-CoV2373 produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, after a single dose of the vaccine. Participants treated with Novavax’ vaccine also demonstrated higher levels of antibodies after two doses compared to the levels observed in recovered COVID-19 patients.
The company added that the addition of its Matrix-M adjuvant boosted the effect of the vaccine in the early-stage study. Antibody responses produced by NVX-CoV2373 were also highly correlated with neutralisation tiers, which demonstrates that a significant number of the antibodies were functional.
Although the vaccine was generally well-tolerated, some participants experienced local symptoms and systemic events, including headache, fatigue and myalgia (muscle pain).
“The phase 1 data demonstrates that NVX-CoV2373 with our Matrix-M adjuvant is a well-tolerated COVID-19 vaccine with a robust immunogenicity profile,” said 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 neutralising antibody titers greater than those observed in a pool of COVID-19 patients with clinically significant disease,” he added.
At the beginning of the month, Novavax was awarded $1.6bn by the US government under the Operation Warp Speed scheme to accelerate the research and development of its vaccine candidate.
Under the terms of the deal, Novavax will produce 100 million doses of its vaccine by the beginning of 2021, if it continues to prove effective in further clinical studies.
The agreement also allows for the US government to exercise an option to procure additional doses of Novavax’ vaccine, to further support its goal of delivering 300 million doses of a safe and effective COVID-19 vaccine by January 2021.
Following the positive phase 1 results, Novavax will promptly begin the phase 2 portion of the vaccine at a number of sites in multiple countries to evaluate if NVX-CoV2373 can prevent SARS-CoV-2 infection or reduce the severity of COVID-19 in a larger pool of participants.