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Novavax applies to WHO for emergency use of its COVID-19 vaccine

Posted: Thursday, September 23, 2021. 12:51 pm CST.

By Rubén Morales Iglesias: Biotechnology company Novavax Inc. and its partner Serum Institute of India (SII) have applied to the World Health Organization (WHO) for emergency use listing (EUL) of the Novavax’s COVID-19 vaccine, according to a statement by Novavax Inc.

The companies made the announcement on Thursday saying the application to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India (DCGI).

Novavax said the application is made with the intention of exporting the vaccine to countries participating in the COVAX facility that was established by the WHO to distribute vaccines equitably worldwide.

“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 need for multiple approaches to help control the pandemic.”

The EUL by the WHO is a prerequisite to export COVID-19 vaccines to countries participating in the COVAX Facility.

Novavax said that apart from the EUL application to the WHO, last month the company “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.”

The Novavax COVID-19 Vaccine is stored at two to eight degrees Celsius and is applied in two doses.


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