SII applies to Indian authorities for full market authorisation of Covishield

Serum Institute of India SII CEO Adar Poonawala said the vaccines major has applied to Indian authorities for full market authorisation of Covishield stating supplies of the Covid19 vaccine have exceeded 125 crore dosesSII had partnered with the developer of Covishield AstraZeneca for the supply of the vaccine to the Indian government which had in January this year granted emergency use authorisation in the country Supplies of the COVISHIELD vaccine in India have exceeded 125 billion dosesThe government of India now has enough data for full market authorisation and therefore SerumInstIndia has applied to the CDSCO_INDIA_INF DCGI and MoHFW_INDIA for this permission Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation CDSCO and Ministry of Health and Family Welfare Covishield along with Bharat Biotechs Covaxin were the first two vaccines approved by the Drugs Controller General of India DCGI in January this year under emergency use authorisation against the pandemicAlready in the US PfizerBioNTechs Covid19 vaccine has received full USFDA approval for use in individuals 16 years of age and older transitioning from an earlier emergency use authorisation EUA approval EUA is granted by authorities during public health emergencies to provide access to medical products after determining that the known and potential benefits of a product when used to prevent diagnose or treat the disease outweigh the known and potential risks of the product In case of full market authorisation the vaccines need to undergo the standard regulatory process for reviewing the quality safety and effectiveness of medical productsIn October this year the Punebased SII had submitted the final phase 23 clinical study report of India with its application for grant of regular market authorization for Covishield The firm had also submitted phase3 clinical study results of 24244 subjects from the UK Brazil and South Africa on June 8 2021 to the CDSCOAlso phase3 clinical study results of 32379 subjects from the US Chile and Peru were submitted on July 9 Earlier this week SIIs Covid19 vaccine Covovax Biological Es jab Corbevax and antiCOVID pill Molnupiravir were granted emergency use authorisation in India Prior to that six Covid19 vaccines SIIs Covishield Bharat Biotechs Covaxin Zydus Cadilas ZyCoVD Russias Sputnik V and the USmade Moderna and Johnson and Johnson had already received EUA from the Indian drug regulatorAlso Read Nasal vaccine might help fight new Covid19 variants StudyThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever