November 5, 2021 -- Novavax has completed its rolling submission to the World Health Organization (WHO) for emergency use listing of NVX-CoV2373, its COVID-19 vaccine candidate.
The company has completed its submission to WHO of all the modules required for the regulatory evaluation of its vaccine candidate, which is manufactured in partnership with the Serum Institute of India. Novavax said it will make further submissions to enable vaccine supply from additional manufacturing sites.
The company said it recently received authorization for its vaccine in Indonesia. It has submitted regulatory filings in the U.K., Australia, New Zealand, and Canada. Novavax said that it has also submitted data and modules in the European Union to support final regulatory review. Novavax expects to submit the complete package to the U.S. Food and Drug Administration by the end of the year.