Novavax Begins Phase 2 Trial of its COVID-19 Vaccine

Novavax announced yesterday that it has enrolled its first volunteers in a phase 2 trial of its COVID-19 vaccine candidate NVX-CoV2373.

The trial is a continuation of an ongoing phase 1/2 trial the company began in Australia in May, in which NVX-CoV2373 produced neutralizing antibodies in every participant after a single dose (DID, Aug. 5).

The phase 2 study will evaluate the safety and immunogenicity of the experimental vaccine with the company’s Matrix-M adjuvant in participants ages 18 to 84 years old.

Novavax plans to enroll up to 1,500 participants across 40 sites in the U.S. and Australia. Participants will be given either 5 mcg or 25 mcg injections of the vaccine, each with 50 mcg of the adjuvant.

The trial is supported with funding from the Coalition for Epidemic Preparedness Innovations, which gave the company $384 million for manufacturing and clinical studies through phase 2 testing (DID, May 13).

Novavax began a separate phase 2b trial of NVX-CoV2373 last week in South Africa to assess its efficacy in 2,665 healthy patients, as well as its safety and immunogenicity in 240 HIV-positive adults (DID, Aug. 18). — Jordan Williams