Novavax to Create an Omicron-Specific Vaccine, While Assessing Current Jab’s Effect On the Variant

Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus.

“The initial steps required to manufacture an Omicron-specific spike are underway and GMP manufacturing in a commercial facility is anticipated in January 2022,” the company said. “Lab-based assessment of a new strain-matched nanoparticle vaccine will begin within a few weeks.”

The current vaccine (known as Covavax outside the U.S.), which is yet to be authorized in the U.S., is effective against the Alpha, Beta and Delta strains of the SARS-CoV-2 virus that causes COVID-19 infection, the company said.

Novavax will determine whether antibodies from people vaccinated with Covavax can also neutralize the Omicron variant. The company said it will probably know the answer within a few weeks and will also begin testing whether antibodies from previously vaccinated individuals can neutralize the Omicron variant.

Unlike the messenger-RNA vaccines developed by Pfizer-BioNTech and Moderna or the adenovirus-based vaccine from Johnson & Johnson, Covavax combines a recombinant protein and an adjuvant designed to boost the body’s immune response. In a late-stage trial, the vaccine proved to be 100 percent effective in preventing moderate and severe disease, and more than 90 percent effective at preventing symptomatic infections.

Novavax is expected to seek an FDA Emergency Use Authorization for the vaccine this month. 

Covavax was approved in mid-November for use in the Philippines — one of nine vaccines being used there. The company has also filed for the vaccine’s approval in the European Union, Canada and Indonesia (DID, Nov. 8).

In September, Novavax and manufacturing partner Serum Institute of India applied for an emergency use listing (EUL) by the World Health Organization (WHO). Such a designation would make Covavax available to numerous developing nations under the WHO-backed COVAX vaccine-sharing program (DID, Sept. 24). — Michele G. Sullivan