Novavax, Serum seek emergency use approval from WHO for Covid vaccine

The submission to WHO was based on the companies’ previous regulatory submission to the Drugs Controller General of India (DCGI).

Biotech company 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’ previous 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 well as in COVAX countries.

SII and Novavax had completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines in August for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data.

SII has a commitment to supply 1 billion doses of the Novavax vaccine. It is manufacturing the vaccine and is responsible for commercialising the vaccine in India and low- and middle-income countries. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.

SII and Novavax were awaiting regulatory clearances, which delayed the vaccine launch. Raw material supply constraints, too, added to the production challenges. SII CEO Adar Poonawalla had said they had started stockpiling the vaccine but at a smaller scale. SII had worked on developing alternative vendors, but this had taken time and these new suppliers too were inundated with demand from all vaccine makers, he had said.

Stanley C Erck, president and CEO of Novavax, said the submission for EUL was a significant step on the path to accelerating access and more equitable distribution to countries. The grant of EUL by WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries 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 overall in Phase III trials in the UK. In a Phase 3 clinical trial with nearly 30,000 adults in the US and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe Covid-19 infection and 90.4% overall efficacy.