Covishield vaccine: Once opened, multi-dose vials must be used within 6 hours when stored between 2 degree Celsius to 8 degree Celsius, the DCGI said. (Reuters image)Covishield vaccine update: Drugs Controller General of India (DCGI) has granted permission to Serum Institute of India to manufacture the ‘Covishield’ Covid-19 vaccine. The approval has been granted for active immunization of persons aged 18 years or above against the Coronavirus. The DCGI has stated that the second dose of Covishield must be administered between four to six weeks after the inoculation of the first dose. However, data ascertained from overseas studies have disclosed that a second dose can be administered up to 12 weeks after the first dose, the DCGI said in a statement.
The Covishield has a shelf life of six months when stored at 2 degree celsius to 8 degree celsius. Once opened, multi-dose vials must be used within 6 hours when stored between 2 degree celsius to 8 degree celsius, the DCGI said.
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and January 2 and made recommendations in respect of the proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India (SII). SII has presented a Recombinant Chimpanzee Adenovirus vector vaccine Covishield encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from Oxford-AstraZeneca.
The firm submitted safety, immunogenicity, and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent. Further, the SII was granted permission to conduct Phase 2 and Phase 3 clinical trials on 1,600 participants within India. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. After detailed deliberations, the Subject Expert Committee has recommended the grant of permission for restricted use in an emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
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