Drugs Controller General of India (DCGI) is likely to give its final approval to Serum Institute of India's Covishield by today evening, as per sources. The vaccine, developed jointly by Serum Institute and Oxford University, has already received approval from the Subject Expert Committee at the Central Drugs Standard Control Organisation (CDSCO).
While granting emergency use authorisation, the expert panel placed certain conditions such as the two dose shot is indicated for active immunisation in individuals of 18 years or more, and that it should be administered intramuscularly at a gap of 4 to 6 weeks.
Pune-based Serum Institute will have to provide safety, efficacy and immunogenicity data from the ongoing clinical trials in India and globally. SII, the biggest vaccine manufacturer globally by volume, will also have to provide data on adverse effects following immunisation (AEFI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of coronavirus vaccine trials in India.
Oxford-AstraZeneca's coronavirus jab has an efficacy rate of 70 per cent after two full doses. One of the regimes with a half dose and a full dose, however, showed 90 per cent efficacy rate.
Though an official agreement has not been signed between Serum Institute and the Indian government, SII CEO Adar Poonawalla stated India will benefit from the initial stock of about 40-50 million Covishield vaccines, most of which will be provided at a price of Rs 220 per dose.
The UK and Argentina have approved AstraZeneca's COVID-19 shot prior to India and begun the vaccine rollout process. Meanwhile, the CDSCO is also looking at the emergency use authorisations filed by Pfizer-BioNTech and Bharat Biotech for BNT162b2 and Covaxin respectively.