Novavax Seeks Authorization of COVID-19 Vaccine in UK

Novavax has completed its submission to the UK’s Medicines and Healthcare products Regulatory Agency for conditional marketing authorization of its COVID-19 vaccine, NVX-CoV2373.

The submission was supported by a 15,000-person phase 3 UK trial showing that the vaccine candidate had 96.4 percent efficacy against the original coronavirus, 86.3 percent efficacy against the Alpha variant and overall efficacy of 89.7 percent.

The submission also included data from a 30,000-participant study in the U.S. and Mexico demonstrating the shot offered 100 percent protection against moderate and severe disease and overall efficacy of 90.4 percent, the company said.

Novavax expects to finish filing its EU application shortly and will seek an FDA Emergency Use Authorization by year’s end.