Novavax starts rolling reviews for COVID-19 vaccine
The recombinant protein-based vaccine candidate, NVX-CoV2373, is currently in Phase 3 trials in the US and UK. It reports that the vaccine shows 89.3% efficacy, including against the UK variant; as well as suggesting 50% efficacy against the South African variant on the basis of its Phase 2b trial.
“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 M. Glenn, MD, 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.”
The Gaithersburg, Maryland headquartered company has also started developing new constructs against the South African strain and expects to select ideal candidates for further development into either a booster and/or combination bivalent vaccine in the coming days. Clinical testing of these new vaccines will follow in the second quarter of this year.
