Biotechnology firm Novavax, Inc. and its partner Serum Institute of India has applied to the World Health Organization (WHO) for an emergency use listing of its COVID-19 vaccine.
The WHO’s emergency use listing is an assurance to national regulatory authorities of the product’s safety and efficacy. It is also a requirement to deliver vaccines to several countries participating in the Covax vaccine sharing facility which has been set up for lower-income countries.
“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, President, and Chief Executive Officer, Novavax.
“It represents another major milestone in Novavax’s 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,” added Erck.
The Novavax vaccine is a protein-based vaccine that achieved 90.4% protective efficacy overall in phase 3 trials carried out in the US and Mexico, with 100% efficacy against moderate to severe COVID-19 disease.
Novavax and Serum Institute said they expected to produce doses at a rate of 100 million a month very soon and 150 million per month by year-end.
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