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Novavax Files for COVID-19 Vaccine Authorization in Multiple Countries

Novavax was approved for their first COVID-19 vaccine EUA in Indonesia, and expects more to follow shortly.

This week, Novavax announced its completion of submissions to Health Canada and the European Medicines Agency to authorize its COVID-19 vaccine candidate, NVX-CoV2373.

Novavax’s shot is intended to be administered intramuscularly in 2 0.5 mL doses 21 days apart. If approved, it will be the first protein-based COVID-19 vaccine.

"Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world. We thank the Government of Canada and the European Commission for their ongoing partnership and confidence in our COVID-19 vaccine program," said Stanley C. Erck, President and Chief Executive Officer of Novavax.

NVX-CoV2373 was approved for Emergency Use Authorization (EUA) in Indonesia on Monday, and Novavax expects approval in India and the Philippines to follow in the coming weeks. Novavax has also announced regulatory findings in the UK and Australia, and plans to file in those countries as well.

Following the approval in Indonesia, the vaccine will be manufactured by the Serum Institute in India (SII) and sold under the brand name Covovax. Novavax and SII are now waiting for the World Health Organization (WHO) to approve their regulatory filing, as they have committed to producing at least 1.1 billion doses for the WHO’s COVAX program, providing COVID-19 vaccinations to low-income countries.

Though Novavax is not actively seeking approval for NVX-CoV2373 is the US, they plan to submit their vaccine to the FDA by the end of the year. Novavax had originally intended to file for an EUA in the US earlier this year, but were delayed due to production and quality concerns.

Novavax said in a statement that NVX-CoV2373 met all primary objectives in its phase 3 trial PREVENT-19; the trial, consisting of 30000 participants in the US and Mexico, demonstrated 100% protection against moderate to severe COVID-19 and 90.4% overall efficacy. A phase 3 trial of 15000 participants in the UK showed NVX-CoV2373 as having 96.4% demonstrated efficacy against the original strain, 86.3% efficacy against the Alpha (B.1.1.7) variant, and 89.7% efficacy overall.

NVX-CoV2373 is a protein-based vaccine, engineered from the SARS-CoV-2 virus that caused COVID-19. Investigators used Novavax’s recombinant nanoparticle technology to generate antigen derived from the COVID-19 Spike protein. NVX-CoV2373 is formulated with Novavax’s saponin-bases adjuvant to enhance immune response and induce high levels of COVID-19-neutralizing antibodies.