The protein-based vaccine candidate NVX-CoV2373 is made from the genetic sequence of the first SARS-CoV-2 strain. It is adjuvanted with the company’s saponin-based Matrix-M to boost immune response and neutralising antibodies. The candidate proved to offer a high level of protection against B.1.351.
The randomised, observer-blinded, placebo-controlled Phase IIb trial assessed efficacy, safety and immunogenicity of the vaccine in healthy adult subjects and in a cohort of adults with human immunodeficiency virus who are medically stable.
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Data showed that the trial met its primary endpoint.
According to the initial primary analysis results, the vaccine candidate showed 49% overall efficacy and had an efficacy of 49% in the complete analysis, which is not published yet.
NVX-CoV2373 had 60% and 55% efficacy in the initial analysis and full analysis, respectively, in healthy adult subjects.
Covid-19 cases observed during initial analysis were mostly mild-to-moderate and due to the south African B.1.351 variant.
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By GlobalDataFurthermore, previous infection with the original SARS-CoV-2 strain did not provide protection against B.1.351 variant infection during follow-up of 60 days.
The full trial analysis demonstrated a moderate protective effect of previous infection with original virus strain.
Among placebo recipients, at 90 days of follow-up, the illness rate was 8% in baseline seronegative participants and 5.9% in baseline seropositive participants.
In the placebo group, the illness rate was 8% and 5.9% in baseline seronegative and seropositive subjects, respectively, at 90 days of follow up.
Novavax Research and Development (R&D) president Gregory Glenn said: “This data publication reinforces the encouraging safety profile and cross-protective effect across variants seen in studies of our vaccine to date.
“It also demonstrates that ongoing evaluation of Covid-19 vaccine efficacy against SARS-CoV-2 variants is urgently needed to inform vaccine development and use.”
This week, Novavax expanded the ongoing Phase III PREVENT-19 clinical trial of NVX-CoV2373 to include a paediatric arm.
