The initial primary analysis highlights cross-protection by the Novavax COVID-19 vaccine against the B1.351 variant prevalent in South Africa. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2. n pre-clinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing. Phase 2b randomized, observer-blinded, placebo-controlled trial conducted in South Africa evaluated the efficacy, safety and immunogenicity in healthy adults, and a small cohort of medically stable adults living with HIV.
The study met its primary endpoint – i.e., the Novavax vaccine demonstrated an overall efficacy of 49% in the initial analysis and 49% in the subsequent complete analysis. Among healthy adults without HIV, the Novavax vaccine demonstrated the efficacy of 60% in the initial analysis and 55% in the subsequent complete analysis. In the initial analysis, cases were predominantly mild-to-moderate and due to the B.1.351 variant that dominates in South Africa, and increasingly in southern Africa. In the subsequent complete analysis, circulation of the B.1.351 variant continued to dominate, and all five cases of severe disease observed in the trial occurred in the placebo group.
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