- Novavax Inc NVAX and its partner Serum Institute of India Pvt. Ltd. (SII) have announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant.
- The submission is based on the companies' previous regulatory submission to the Drugs Controller General of India (DCGI).
- The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility established to allocate and distribute vaccines equitably.
- In addition to the submission for WHO EUL, SII and Novavax completed the submission of modules last month as required by regulatory agencies in India, Indonesia, and the Philippines.
- Preliminary data reported last month showed that a single booster dose at six months of NVX-CoV2373 elicited a 4.6-fold increase in functional antibody titers.
- A six-fold increase in cross-reactive functional antibodies to Delta variant compared to primary vaccination series was seen.
- Price Action: NVAX stock is up 9.48% at $254 during the market session on the last check Thursday.
- Image by hakan german from Pixabay
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