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Novovax, SII seek WHO’s approval for their COVID vaccine

Biotechnology firm Novavax along with its partner Serum Institute of India (SII) has sought the World Health Organization’s approval for emergency use listing (EUL) of its Covid-19 vaccine, said the company in a statement on Thursday.

“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,” said Stanley C Erck, the president and chief executive officer of Novavax.

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

The company further said that the EUL by the WHO is a prerequisite for exports to numerous countries participating in the Covax facility.

Efficacy of vaccine
The Novovax Covid-19 vaccine is being evaluated in two pivotal phase 3 trials.

The first is in the UK, which demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.

The second is the PREVENT-19 trial in the US and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.

It is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2.

“NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies,” said the company.

The vaccine contains purified protein antigen and can neither replicate, nor can it cause Covid-19, it added.

he vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart.

Novavax had last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Mint

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