Indian Council of Medical Research chief Balram Bhargava on Tuesday said Bharat Biotech’s Covid-19 vaccine has been cleared in the clinica...
Indian Council of Medical Research chief Balram Bhargava on Tuesday said Bharat Biotech’s Covid-19 vaccine has been cleared in the clinical trial mode, reported the Hindustan Times. The Drugs Controller General of India has faced criticism from scientists for the decision to grant emergency use authorisation to Bharat Biotech’s Covid-19 vaccine without phase-three trial data about its efficacy and safety.
“Permission for restricted use in clinical trial mode has been allowed, which means consent of participants has to be taken and there has to be a regular follow up of participants,” Bhargava said at a press conference.
Clinical trials are divided into three phases. Phase 1 of a clinical trial is usually small and is used to determine its safety profile. Phase 2, on the other hand, employs a bigger sample size, and looks at the immune responses triggered by the vaccine. However, a vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants. Covaxin’s third-phase trial is still underway.
On January 3, the Drug Controller General of India approved Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield vaccines for restricted emergency use in the country. The Serum Institute is the local maker of Covishield, the vaccine developed by Oxford University...
