Novavax Commences Late-stage Trial Of COVID-19 Vaccine In U.S.

(RTTNews) - Novavax Inc. (NVAX) has begun a late-stage trial of its COVID-19 vaccine candidate NVX-CoV2373 in the U.S.

The drug maker had delayed the trial twice due to issues in scaling up the manufacturing process.

In a statement, Novavax announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate.

The trial will enroll up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo, the company said.

Novavax was awarded $1.6 billion in funding from the U.S. government and this award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up.

Novavax has also signed supply agreements with several countries and is set to provide 60 million doses to the U.K.. The interim data from the trial is expected in the first quarter of 2021.

A phase IIb trial underway in South Africa is now fully enrolled, which also includes medically stable, HIV-positive participants.