CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
The vaccine has been developed by the National Equine Research Center, Hisar (Haryana) in collaboration with the Indian Veterinary Research Institute, Izzatnagar (Bareilly)
This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.
This will not only strengthen the country’s overall position in the global vaccine industry but also reduce its reliance on foreign vaccines
Up to $30m funding will be provided to advance an innovative vaccine technology that could protect against current and future SARS-CoV-2 variants and other SARS-like Betacoronaviruses.
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
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