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Novavax provides additional data on COVID-19 vaccine candidate

September 3, 2020

Novavax (NASDAQ:NVAX) announces the publication of Phase 1 data from its Phase 1/2 trial of COVID‑19 vaccine candidate NVX‑CoV2373, adjuvanted with Matrix‑M, in 131 healthy adults 18-59 years of agein The New England Journal of Medicine.

The publication offers further detail on the previously announced NVX‑CoV2373 results with and without the Matrix-M adjuvant.

After randomization, 83 participants were assigned to receive the vaccine with adjuvant and 25 without adjuvant, and 23 participants were assigned to receive placebo.

The addition of adjuvant resulted in enhanced immune responses, was antigen dose–sparing, and induced a T helper 1 (Th1) response. The two-dose 5-μg adjuvanted regimen induced geometric mean anti-spike IgG (63,160 ELISA units) and neutralization (3906) responses that exceeded geometric mean responses in convalescent serum from mostly symptomatic COVID-19 patients (8344 and 983, respectively).

No serious adverse events were noted. Reactogenicity was absent or mild in the majority of participants, more common with adjuvant, and of short duration (mean, ≤2 days).

NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in COVID-19 convalescent serum.

The Matrix-M1 adjuvant induced CD4+ T-cell responses that were biased toward a Th1 phenotype.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials.

The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

After closing with a 2.07% decline at $102.90 in Wednesday’s regular session, shares gained 3.79% and topped $106.80 in after-hours trading.

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