GAITHERSBURG, Md., Sept. 23, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-MTM adjuvant. The submission to WHO is based on the companies' previous regulatory submission to the Drugs Controller General of India (DCGI).
"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' 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 grant of EUL by the 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. In addition to the submission for WHO EUL, SII and Novavax 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
https://ir.novavax.com/2021-09-23-Novavax-and-Serum-Institute-of-India-Announce-Submission-to-World-Health-Organization-for-Emergency-Use-Listing-of-Novavax-COVID-19-Vaccine?asPDF
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.
