Biotech business Novavax and vaccine maker Serum Institute of India (SII) have applied to the World Health Organisation (WHO) for an emergency use listing (EUL) for the Novavax Covid-19 vaccine.
Novavax and SII made regulatory submissions to WHO for EUL of Novavax’s recombinant nanoparticle protein-based Covid-19 vaccine candidate with Matrix-M adjuvant. The submission to WHO was based on the companies’ prior regulatory submission to the Drugs Controller General of India (DCGI).
An EUL from WHO would pave the way for the launch of the Novavax vaccine in India as properly as in COVAX nations.
SII and Novavax had completed the submission of modules necessary by regulatory agencies in India, Indonesia and the Philippines in August for the initiation of critique of the vaccine, which includes preclinical, clinical, and chemistry, manufacturing and controls information.
SII has a commitment to provide 1 billion doses of the Novavax vaccine. It is manufacturing the vaccine and is accountable for commercialising the vaccine in India and low- and middle-revenue nations. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.
SII and Novavax have been awaiting regulatory clearances, which delayed the vaccine launch. Raw material provide constraints, as well, added to the production challenges. SII CEO Adar Poonawalla had stated they had began stockpiling the vaccine but at a smaller sized scale. SII had worked on building option vendors, but this had taken time and these new suppliers as well have been inundated with demand from all vaccine makers, he had stated.
Stanley C Erck, president and CEO of Novavax, stated the submission for EUL was a important step on the path to accelerating access and more equitable distribution to nations. The grant of EUL by WHO is a prerequisite for exports to various nations participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating nations and economies.
The NVX-CoV2373 vaccine had demonstrated an efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy all round in Phase III trials in the UK. In a Phase 3 clinical trial with practically 30,000 adults in the US and Mexico, NVX-CoV2373 demonstrated one hundred% protection against moderate and serious Covid-19 infection and 90.4% all round efficacy.