Novavax (NVAX) and Serum Institute of India Granted Emergency Use Authorization for Novavax' COVID-19 Vaccine in Indonesia

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Novavax (NVAX) Files for Provisional Approval of its COVID-19 Vaccine in New Zealand

November 3, 2021 9:30 AM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the company has filed for provisional approval of the vaccine to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

"Today's submission marks Novavax' continued progress in bringing the first protein-based COVID-19 vaccine based on phase 3 data to the global community," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain laser-focused on delivering our... More

Novavax (NVAX) Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to EMA

November 1, 2021 6:20 AM EDT

Health Canada filing marks first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in CanadaSubmission of all modules required for regulatory review, including CMC and clinical data, are now complete for European Medicines Agency

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada.... More

Novavax (NVAX) Files Requesting Provisional Approval of its COVID-19 Vaccine in Australia

October 29, 2021 7:15 AM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine candidate. The company's application to the TGA marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.

"This submission brings Novavax significantly closer to delivering doses of the first protein-based COVID-19 vaccine to Australia and, along with this week's filing for... More