Novavax has announced the start of the rolling review process for authorisation of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its Phase III trials in the UK and US and through initial authorisation for emergency use granted under country-specific regulations.
“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.”
To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.
Novavax’ recombinant protein-based vaccine candidate is currently in Phase III clinical development in both the UK and US for the prevention of COVID-19. It has demonstrated clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa, says Novavax.