Novavax’s COVID-19 vaccine produces immune response in early study

Novavax has reported positive results from the Phase I portion of its Phase I/II study of its COVID-19 vaccine candidate NVX-CoV2373.

The Phase I portion included a randomised, observer-blinded, placebo-controlled trial which evaluated the immunogenicity and safety of the vaccine, both adjuvant with the company’s proprietary Matrix-M adjuvant and unadjuvanted, in 131 health participants 18 to 59 years of age at two sites in Australia.

The results from the early study show that two dose levels of the vaccine – 5 micrograms and 25 micrograms – produced an immune response in participants, with antibody levels similar to those observed in recovered COVID-19 patients.

According to Novavax, participants receiving two doses of the adjuvanted vaccine developed the most significant levels of neutralising antibodies against SARS-CoV-2, the virus which causes COVID-19.

Two weeks after participants received the second dose of the adjuvant shot, they had antibody levels that were superior to the recovered COVID-19 patient group.

The vaccine was generally well-tolerated, with a few mild side-effect including headache, fatigue and muscle pain, with no serious side-effects reported.

“The Phase I data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well-tolerated COVID-19 vaccine with a robust immunogenicity profile,” said Gregory M. 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,” he added.