EMA recommends Nuvaxovid for authorisation, as WHO grants second Emergency Use Listing

pharmafile | December 22, 2021 | News story | Research and Development  

Nuvaxovid™, the COVID-19 vaccine manufactured by the biotechnology company Novavax, has been listed for emergency use by WHO. The news follows the EMA’s positive recommendation and proceeding authorisation of Nuvaxovid for use in the EU.

Nuvaxovid is a recombinant protein nanoparticle COVID-19 vaccine, with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The Emergency Use Listing for Nuvaxovid accompanies listing for the Novavax vaccine, manufactured and marketed as Covovax™, in India and licensed territories. Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology, and the authorisations are based on a common pre-clinical, clinical and chemistry manufacturing and controls (CMC) package.

“Today’s Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase COVID-19 vaccine access across the globe through a protein-based option built on a well-understood platform,” said Stanley C Erck, President and Chief Executive Officer, Novavax. “We thank the World Health Organisation for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy.”

The recommendations are based on data submitted by Novavax, demonstrating the efficacy, safety and quality of the vaccine. This included data from two pivotal Phase III clinical trials: PREVENT-19, which enrolled almost 30,000 participants in the US and Mexico, and achieved an overall efficacy of 90.4%; and a trial with more than 14,000 participants in the UK that achieved an overall efficacy of 89.7%. The results of both of these were published in the New England Journal of Medicine (NEJM).

In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile. Novavax will continue to collect and analyse real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Ana Ovey

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