By Dhirendra Tripathi
Investing.com – Novavax stock (NASDAQ: NVAX ) climbed 9% Thursday after the company applied with the World Health Organization for emergency approval to its much-delayed Covid-19 vaccine.
The application, filed jointly with its partner Serum Institute of India, follows the companies' previous regulatory submission to the Drugs Controller General of India.
The grant of emergency use license by the WHO is a prerequisite for exports to countries participating in the Covax facility, which was established to allocate and distribute vaccines equitably to participating countries.
Novavax and SII 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. SII is the world's largest vaccine manufacturer by capacity and also makes the Covid-19 shot developed by AstraZeneca.
The submission of the application comes after several months of delay that has seen the likes of Pfizer (NYSE: PFE )-BioNTech (NASDAQ: BNTX ), Moderna (NASDAQ: MRNA ), AstraZeneca (NASDAQ: AZN ) and Gamaleya (Sputnik) race ahead in providing vaccines to millions of people worldwide.
The vaccine, NVX-CoV2373, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the coronavirus and comes at a time when the virus has mutated, leaving its Delta variant as the dominant strain in most countries of the world.
NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
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