Novavax (NASDAQ:NVAX) announces positive results from the first portion of its Phase 1/2 clinical trial evaluating its COVID-19 vaccine candidate, NVX-CoV2373, with and without the Matrix-M adjuvant, in healthy adults between 18 and 59 years of age.
NVX-CoV2373 was well-tolerated with mild reactogenicity events, mostly injection site pain and tenderness, while systemic events, less frequent, included headache, fatigue and myalgia (muscle pain) after dose 1 (5 µg). Reactogenicity was greater after dose 2 (25 µg) as expected since it was a higher dose. The average duration of events was less than two days.
On the immunogenicity front, the vaccine induced 100% neutralization titers in all participants. All subjects developed anti-spike IgG antibodies after one dose while many also developed wild-type virus neutralizing antibody responses. After the second dose, all participants developed wild-type virus neutralizing antibody responses. The IgG responses were highly correlated with neutralization titers.
The company has submitted the results for publication.
Management will host a conference call today at 5:00 pm ET to discuss the results.
Although conspicuously absent from the press release, eight participants had to be hospitalized as reported by STAT News.
The data have apparently spooked investors. Shares are down 29% after hours although due for a rest. The stock is up over 39-fold this year.
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