It comes on the back of receiving the first regulatory authorization for its vaccine, which was granted in Indonesia last week. The company has also made regulatory filings for its vaccine in the UK, Australia, New Zealand and Canada and the EU. It expects to submit the complete package to the US Food and Drug Administration (FDA) by the end of the year.
The grant of an WHO EUL is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
“This submission reflects our continued focus on accelerating access and equitable distribution as we work to bring our vaccine to people in need around the globe,” said Stanley C. Erck, president and CEO, Novavax, as the company announced the completed submission last Thursday. “We continue to work with urgency to deliver our COVID-19 vaccine, built on a proven, well-understood vaccine platform, because no one is safe until everyone is safe.”
Novavax has now completed the submission to WHO of all modules required for the regulatory evaluation of its COVID-19 vaccine: a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
The chemistry, manufacturing and controls (CMC) module submitted to WHO, as well as other regulatory agencies worldwide, is based on Novavax’s manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume.