Multiple rolling reviews kick-off for Novavax’s COVID-19 vaccine

Rolling reviews of Novavax’s COVID-19 vaccine have kicked-off in the UK, US, EU and Canada following the recent announcement that the jab demonstrated 89.3% efficacy in a phase III trial.

The rolling review process of the vaccine, NVX-CoV2373, has commenced with several regulatory agencies, including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Agency (MHRA) and Health Canada.

“The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide,” said Gregory Glenn, president of research and development, Novavax.

“We appreciate the agencies’ confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination,” he added.

In a phase III trial conducted in the UK, the first interim analysis found 56 cases of COVID-19 in the placebo group compared to six cases in the NVX-CoV2373 group.

This reflected a point estimate vaccine efficacy of 89.3%, with the preliminary analysis indicating that the UK variant was detected in over 50% of the PCR-confirmed symptomatic cases.

For the efficacy of the vaccine by strain, the researchers found that NVX-CoV2373 was 95.6% effective against the original COVID-19 strain and 85.6% effective against the UK variant.

Meanwhile, in a Phase IIb trial in South Africa, the vaccine was found to have 60% efficacy for the prevention of mild, moderate and severe COVID-19.

In this study, 29 cases were observed in the placebo group and 15 in the vaccine group, with one severe cases occurring in the placebo group and all other cases being mild-to-moderate.

Preliminary sequencing data was available for 27 of 44 COVID-19 events in this study – this found that 92.6% of cases were due to the recently discovered South Africa variant.