Novavax announces vaccine’s high efficacy against original and variant COVID-19 strains
pharmafile | March 12, 2021 | News story | Medical Communications | COVID-19, Novavax, vaccines
Novavax has announced final efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain in a pivotal UK Phase III trial of its vaccine NVX–CoV2373.
The study enrolled more than 15,000 participants between 18 and 84 years of age, including 27% aged over 65. The primary endpoint of the UK Phase III clinical trial is based on the first occurrence of PCR-confirmed symptomatic COVID-19, with onset at least 7 days after the second study vaccination in serologically negative adult participants at baseline.
Efficacy was found to be 96.4% against the original virus strain, and 86.3% against the variant first identified in the UK. The study’s primary efficacy endpoint demonstrated an overall vaccine efficacy of 89.7%.
In volunteers aged 65 and older, 10 cases of COVID-19 were observed, with 90% of those cases occurring in the placebo group. Older adults are among the groups most impacted by the disease and are at high risk of complications from COVID-19.
The company also announced the complete analysis of its Phase IIb trial taking place in South Africa, with efficacy of 55.4% among the HIV-negative trial participants in a region where the vast majority of strains are B1.351 escape variants.
Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalisation and death.
Both studies achieved their statistical success criteria, and the final analyses build on the successful interim results announced in January 2021, adding substantially more COVID-19 cases and statistical power.
Stanley C Erck, President and Chief Executive Officer of Novavax, said: “We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials. Importantly, both studies confirmed efficacy against the variant strains.
“With this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19.”
Novavax expects the data to serve as the basis for submission for authorisation to various regulatory agencies worldwide.
Darcy Jimenez
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