Positive interim data from Phase III study of Novavax Covid-19 vaccine released

In the UK study, which assessed efficacy during a period with high transmission and with the new UK variant strain of the virus emerging and circulating widely, the protein-based COVID-19 vaccine candidate (NVX-CoV2373) met the primary endpoint, with a vaccine efficacy of 89.3%.

SPS commentary:

The data presented are from the first interim analysis, which was based on 62 cases of PCR-confirmed symptomatic Covid-19 with onset at least 7 days after the second vaccination (61 mild/moderate and 1 severe). There were 56 cases in the placebo group and 6 in the vaccine group, resulting in a point estimate of efficacy of 89.3% (95% CI 75.2-95.4). Preliminary findings suggest the UK variant strain was detected in over 50% of cases; post-hoc analyses suggest efficacy was 95.6% against the original strain and 85.6% against the UK variant strain. Further data from this ongoing study will be released when available.

The company have also reported data from a Phase 2b clinical trial in South Africa, in which 49.4% efficacy (95% CI6.1-72.8%) was observed overall (60% in the HIV negative population). The triple mutant variant was circulating widely during the time of the study.

NVX-CoV2373 contains a full-length, prefusion spike protein. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike protein and is produced in insect cells. It is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation. A rolling submission to the MHRA was initiated in mid-January.

Biospace Inc.