India has approved Covid-19 virus vaccine of Serum Institute and Bharat Biotech for restricted use in emergency situations, clearing way for roll out of the vaccine against the deadly pandemic.
The approval has been given by the Central Drugs Standard Control Organisation (CDSCO) on recommendations of the Subject Expert Committee.
Permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial, according to a statement of the Ministry of Health and Family Welfare, on January 3, 2021.
”After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial”, the statement said.
It said Serum Institute of India, Pune presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. ”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”.
Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. ”This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country and globally”. Also, Cadila Healthcare has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee of CDSCO.
The Union Ministry of Health & Family Welfare (MoHFW) has been involved in the preparations for roll-out of vaccination in close collaboration with the States/UTs and other stakeholders.In a nation-wide exercise on January 2, an end-to-end mock drill on the vaccine administration was conducted in all States and UTs at 286 session sites spread across 125 districts
Pics courtesy: PIB