Trial data
The study enrolled more than 15,000 participants aged between 18-84 years. The analysis was based on 62 cases of COVID-19 that included 56 cases in the placebo group and 6 cases in the vaccine group. It resulted in an estimated vaccine efficacy rate of 89.3%. The vaccine also showed an efficacy rate of 85.6% against the UK variant strain. The analysis also showed lower levels of severe, serious, and medically attended adverse events.
“NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants. NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.” – Stanley C. Erck, President and CEO, Novavax
South Africa trial
The company’s vaccine candidate displayed an efficacy rate of 60% in the South Africa Phase 2b clinical trial for the prevention of mild, moderate and severe COVID-19 infection. The results were observed in 94% of the study population that was HIV-negative. The trial revealed an efficacy rate of 49.4% in the overall population, which included HIV-positive and HIV-negative subjects.
Novavax has started working on a booster vaccine against the new strains and plans to start testing the new vaccines in the second quarter.
PREVENT-19 trial
The company’s PREVENT-19 trial, which is being conducted in the US and Mexico with support from the US government partnership earlier known as Operation Warp Speed, expects to enrol 30,000 patients in the first half of February. The trial aims to study the efficacy of NVX-CoV2373 with Matrix-M in preventing symptomatic COVID-19 in adult patients.
Vaccine
Novavax’s NVX-CoV2373 contains a spike protein made from its recombinant nanoparticle technology and its saponin-based Matrix-M adjuvant. The purified protein is stable at 2°C to 8°C (refrigerated) and is shipped in a liquid formulation that allows it to be transported using the existing facilities.