Approval application for COVID-19 vaccine pending in Europe

Novavax continues a series of regulatory filings for the COVID-19 vaccine NVX-CoV2373. The US biotech company recently submitted similar applications in Great Britain and Australia – now in Canada. In addition, an application in the European Union is imminent.

“All data and modules have been submitted to the European Medicines Agency (EMA) to support the final regulatory review of its dossier,” Novavax announced on Monday. As a final step, the company is now waiting for the EMA to request conditional approval. In Canada, applications for approval have already been submitted to responsible authorities, Novavax announced today.

“The chemistry, manufacturing and control data packages submitted to Health Canada and the EMA, as well as other global regulatory agencies, leverage Novavax’s manufacturing partnership with Serum Institute of India Pvt. Ltd., the world’s largest supplier of COVID-19 vaccines. They will later be supplemented with data from other production facilities in Novavax’s global supply chain,” Novavax said. The company also reaffirms its plan to be able to submit the full approval package for the protein-based COVID-19 vaccine NVX-CoV2373 to the FDA by the end of the year.

“Novavax continues to file regulatory filings, which we expect will bring the world’s first protein-based COVID-19 vaccine based on Phase 3 data,” said Stanley C. Erk, Novavax President and CEO. “We thank the Government of Canada and the European Commission for their continued partnership and trust in our COVID-19 vaccine programme,” the manager said.