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Dimapur, Jan. 3 (EMN): In a significant development, the Drugs Controller General of India (DCGI) on Sunday approved restricted emergency use of two Covid-19 vaccines, one developed by Oxford University and AstraZeneca, and the other by Bharat Biotech.
The announcement came after the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and the 2nd and made its recommendations in respect of proposal for restricted emergency approval of covid vaccines, informed an update from DCGI.
The Pune-based Serum Institute of India (SII) has partnered with AstraZeneca and the Oxford University to manufacture Covid-19 vaccine Covishield, while Hyderabad-based Bharat Biotech is developing Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology in Pune.
The Indian drug regulator informed that the SII had submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years and above from overseas clinical studies and the overall vaccine efficacy was found to be 70.42%. The world’s largest vaccine manufacturer has also been granted permission to conduct Phase-II/III clinical trial on 1600 participants in India.
On Bharat Biotech’s Covaxin, the DCGI said “the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response”.
“The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue,” read the press release.
The drug regulator has also granted permission to Cadila Healthcare Ltd. for Phase III clinical trial of its Novel Corona Virus-2019-nCov-Vaccine which has been developed by using DNA platform technology.
The Covid-19 vaccines developed by Oxford- AstraZeneca in partnership with SII and Bharat Biotech have to be administered in two doses and all the three vaccines (including the one developed by Cadila Healthcare) have to be stored at 2-8° C, according to DCGI.