Movers and SHAKERS
Covaxin Pediatric Application Filed, Listed for Emergency Use
Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
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Emergency Pediatric Use Application Filed. Ocugen announced that it has filed an Emergency Pediatric Use application for Covaxin in children from age 2 to 18 year of age. The data for the application was from the Phase 2/3 study conducted by Bharat Biotech that included 529 children in its total enrollment of 25,800 patients. Separately, the World Health Organization (WHO) has issued an Emergency Use Listing for Covaxin.
WHO Listing Followed Clinical Data Assessment. Covaxin was reviewed by the WHO's Strategic Advisory Group of Experts on immunization (SAGE), the advisory group that makes WHO vaccination policy. SAGE evaluated the Phase 2 and Phase 3 clinical data for safety and efficacy. It determined that Covaxin meets WHO standards and endorsed its use for vaccination programs worldwide ...
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