Biotechnology firm Novavax Inc said it has completed the rolling submission for the emergency use listing (EUL) of its Covid-19 vaccine candidate to the World Health Organization (WHO).
Earlier on Monday, Novavax and its partner Serum Institute of India (SII) had said that they had received the first emergency use authorisation (EUA) for Covid-19 vaccine in Indonesia.
“The company has now completed the submission to World Health Organization (WHO) of all modules required for the regulatory evaluation of NVX-CoV2373, the company’s recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M adjuvant,” Novavax Inc said in a statement on Thursday.
The chemistry, manufacturing and controls module submitted to WHO, as well as other regulatory agencies worldwide, leverages Novavax’ manufacturing partnership with the SII, the world’s largest vaccine manufacturer by volume, it added.
Novavax will make further submissions to enable vaccine supply from additional manufacturing sites in Novavax’ global supply chain. The filing by Novavax is in addition to a previous filing to WHO by Novavax and SII, the company said.
“Today’s 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,” Novavax President and Chief Executive Officer Stanley C Erck said.
The grant of WHO EUL is a pre-requisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies, Novavax Inc said.
The company continues to work closely with governments, regulatory authorities and non-governmental organisations in its commitment to ensuring equitable global access to its Covid-19 vaccine, it added.