Novavax BA.1 vaccine candidate meets primary stain-change goal

Shares of Novavax (Nasdaq: NVAX) were up as much as 3% in pre-market trading, after the US biotech released top-line results from a Phase III boosting trial for COVID-19, showing that its BA.1 vaccine candidate (NVX-CoV2373) met the primary strain-change endpoint.

The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary, said Novavax, which has been a late-comer to the coronavirus party, missing out on potentially tens of billions in revenue from the first waves of the pandemic.

Additionally, data show no benefit for the Novavax bivalent vaccine candidate compared to the BA.1 vaccine candidate or prototype vaccine in the overall trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and prototype strains showed similar responses across the three vaccine groups (prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + BA.1 vaccine candidate [n=277]). Importantly, for the BA.5 strain (which is structurally similar to BA.1), pseudoneutralization responses demonstrated that there was no benefit for the BA.1 or bivalent vaccine candidates compared to the prototype vaccine.