Novavax Begins South African Efficacy Trial for COVID-19 Vaccine Hopeful

Novavax announced that it has begun a phase 2b clinical trial of its COVID-19 vaccine candidate NVX-CoV2373 in South Africa.

The study will assess the efficacy of the Maryland-based biotech’s experimental vaccine in approximately 2,665 healthy patients, as well as its safety and immunogenicity in approximately 240 HIV-positive adults.

South Africa is experiencing a winter surge of COVID-19 disease, and the trial “has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data,” said Gregory Glenn, Novavax’s president of research and development.

The company is getting $15 million in funding from the Bill and Melinda Gates Foundation to help conduct the randomized placebo-controlled study, which is being led by researchers at  Johannesburg’s Wits University.

The vaccine has proven to be well-tolerated and has produced strong antibody responses in a phase 1 trial in Australia. A phase 2 trial will be launched there and in the U.S. “in the near future,” the company said.

If South Africa’s health regulator approves the vaccine, the Serum Institute of India is expected to supply it to the country under a licensing agreement with Novavax.

Novavax has also expanded a manufacturing deal with Japan’s AGC Biologics to produce the vaccine candidate’s adjuvant component. The partnership, which initially tapped AGC’s Copenhagen, Denmark facility, has now been widened to include the Japanese firm’s Seattle facility to ensure supply for the U.S. — James Miessler