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September 24, 2021updated 21 Oct 2021 9:53am

Novavax and SII seek WHO emergency use listing for Covid-19 vaccine

WHO authorisation is a prerequisite to supply the vaccine to several countries that are part of the COVAX Facility.

Novavax and its partner Serum Institute of India (SII) have submitted an application to the World Health Organization (WHO) seeking emergency use listing (EUL) for the former’s Covid-19 vaccine candidate, NVX-CoV2373.

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A recombinant nanoparticle protein-based vaccine candidate, NVX-CoV2373 is created from the genetic sequence of the first strain of the SARS-CoV-2 virus.

It is formulated with Novavax’s saponin-based Matrix-M to boost the immune response and induce increased levels of neutralising antibodies.

The submission to WHO is based on Novavax and SII’s prior regulatory submission to the Drugs Controller General of India (DCGI).

The WHO EUL is necessary to export to several countries that are part of the COVAX Facility, which was set up to allot and supply vaccines equitably to participating countries and economies.

Last month, the companies concluded the submission of modules needed by regulatory authorities in India, Indonesia and the Philippines to commence the review of the vaccine, including preclinical, clinical and chemistry, manufacturing and controls (CMC) data.

Novavax president and CEO Stanley Erck said: “Today’s submission of our protein-based Covid-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world.

“It represents another major milestone in Novavax’s transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic.”

Earlier this month, the Government of Japan’s Ministry of Health, Labour and Welfare agreed to procure 150 million doses of Novavax’s Covid-19 vaccine candidate produced by Takeda Pharmaceutical in the country on obtaining approval.

Separately, Novavax has reported full data from a pivotal Phase III clinical trial of its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant NanoFlu.

Results showed that NanoFlu was well-tolerated and induced substantially higher humoral and cellular immune responses as against the comparator vaccine.

NanoFlu has already met the primary goal of the trial, showing non-inferior immunogenicity to Fluzone Quadrivalent against all four influenza virus strains included in the vaccine.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
by GlobalData
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