Novavax files for COVID vaccine EUL with WHO
Gaithersburg: Novavax, Inc. has recently announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.
"The 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 Chief Executive Officer, Novavax. "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 NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with MatrixM adjuvant.
"The chemistry, manufacturing and controls (CMC) module submitted to WHO, as well as other regulatory agencies worldwide, leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume," the company said in a release.
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