Background: Biotech Company Novavax announced in March that it has produced a stable, prefusion protein nanoparticle vaccine candidate for COVID-19. A Phase 1/2 trial evaluating NVX-CoV2373 began on 25 May.

Study Design: A randomized, observer-blinded, placebo-controlled trial of 130 healthy participants 18 to 59 years of age at two sites in Australia is being conducted. Patients will receive a two-dose regimen of 5 μg or 25 μg of NVX-CoV2373 with or without Novavax's Matrix‑M adjutant (NCT04368988). A Phase 2b trial is underway in South Africa, which includes two cohorts: a group of 2,665 healthy adults and a group of 240 adults who are HIV positive.

Outcomes: On 4 August, Novavax announced positive Phase 1 results for NVX-CoV2373, indicating participants who had received the vaccine developed an antibody response in participants at multiple dose levels. The candidate also had a favorable safety profile, according to the company.

Status: On August 17, they launched a Phase 2b trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.

The blinded, placebo-controlled trial on 2,900 people will measure not just the safety of the vaccine but its efficacy. Larger, Phase 3 trials are expected to start in October.

If the trials succeed, Novavax expects to deliver 100 million doses for use in the United States by the first quarter of 2021. In August, an executive at the company said it could make well over a billion doses a year for worldwide demand.

Source:

https://novavax.com/