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The submitting by Novavax is along with a earlier submitting to WHO by Novavax and SII. (Picture: Reuters)
The grant of WHO EUL is a pre-requisite for exports to quite a few international locations taking part within the COVAX Facility.
- PTI New Delhi
- Final Up to date:November 05, 2021, 16:13 IST
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Biotechnology agency Novavax Inc mentioned it has accomplished the rolling submission for the emergency use itemizing (EUL) of its COVID-19 vaccine candidate to the World Well being Group (WHO). Earlier on Monday, Novavax and its associate Serum Institute of India (SII) had mentioned that they’d obtained the primary emergency use authorisation (EUA) for COVID-19 vaccine in Indonesia.
“The corporate has now accomplished the submission to World Well being Group (WHO) of all modules required for the regulatory analysis of NVX-CoV2373, the corporate’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant,” Novavax Inc mentioned in a press release on Thursday. The chemistry, manufacturing and controls module submitted to WHO, in addition to different regulatory businesses worldwide, leverages Novavax’ manufacturing partnership with the SII, the world’s largest vaccine producer by quantity, it added.
Novavax will make additional submissions to allow vaccine provide from further manufacturing websites in Novavax’ international provide chain. The submitting by Novavax is along with a earlier submitting to WHO by Novavax and SII, the corporate mentioned. “At present’s submission displays our continued give attention to accelerating entry and equitable distribution as we work to carry our vaccine to folks in want across the globe,” Novavax President and Chief Govt Officer Stanley C Erck mentioned.
The grant of WHO EUL is a pre-requisite for exports to quite a few international locations taking part within the COVAX Facility, which was established to allocate and distribute vaccines equitably to taking part international locations and economies, Novavax Inc mentioned. The corporate continues to work intently with governments, regulatory authorities and non-governmental organisations in its dedication to making sure equitable international entry to its COVID-19 vaccine, it added.
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