New Delhi/Pune: Drug Controller General of India V G Somani on Sunday stated that the Pune-based Serum Institute of India has submitted data of 73 thousand participants while seeking approval for COVISHIELD vaccine from the country’s drug regulatory authority. Somani also assured citizens that the COVISHIELD and COVAXIN vaccines are 100 per cent safe and that they will never approve anything if there is slightest of safety concern.
Somani was speaking after the drug regulatory authority gave approval to COVISHIELD and COVAXIN vaccines of Serum Institute and Bharat Biotech respectively. The approval from the Drug Controller came a day after the government-appointed experts’ panel gave clearance to the vaccines.
COVISHIELD vaccine is developed by the Oxford University and pharma company AstraZenca and is already in use abroad. Somani said, “The COVISHIELD vaccine was found having 70.42 per cent efficacy. Phase 2 and Phase 3 trials on 1,600 participants in India are currently underway. Recommendation was made for restricted use of the vaccine and the trials will continue.”
“We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” he added.