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 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.
Update: Shares have rebounded in after-hours trading, now down only 2%, after STAT News issued a correction to its story after communicating with the company. No participants required hospitalization.
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