Novovax and its partner, the Serum Institute of India (SII) announced on September 23 a regulatory submission to the World Health Organization (WHO) for emergency use listing of its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant.
The submission to WHO is based on Novovax, SII’s previous regulatory submission to the Drug Controller General of India (DGCI) in August 2021 seeking emergency use nod for its protein-based coronavirus vaccine Covovax in India.
Stanley C Erck, President, and CEO, Novovax, 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.”
He added: “It represents another milestone in Novovax’ transformation into a commercial global vaccine company and reinforces the value of global collaboration and the need for multiple approaches to help control the pandemic.
Notably, the grant of emergency use listing by the WHO is a prerequisite for exports to numerous countries participating in the COVAX facility, which was established to allocate and distribute coronavirus vaccines equitably to participating countries and economies.
Aside from applying for WHO’s emergency use nod, Novovax and SII have also announced regulatory submissions to competent authorities in Indonesia and the Philippines for review of its vaccine.
Novavax and SII have pledged to provide more than 1.1 billion COVID-19 vaccine doses to the COVAX facility.
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