DCGIs asks Bharat Biotech to submit protocol for administering COVID-19 vaccine under clinical trial mode
The clinical trial mode means, that everyone will consent for the vaccine, there will be no placebo arm and the recipients will be closely monitored, said ICMR's Balram Bhargava.
January 05, 2021 / 10:49 PM IST
Krishna Ella, Chairman and Managing Director of Bharat Biotech.
Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR), on January 5 said Bharat Biotech has been asked by the Drugs Controller General of India (DCGI) to provide the SOPs (standard operating protcols) for administering its COVID-19 vaccine candidate under clinical trial mode.
"The clinical trial mode means, that everyone will consent for the vaccine, there will be no placebo arm and the recipients will be closely monitored," Bhargava told media.
Bharat Biotech's COVID-19 vaccine has been granted restricted emegency use permission in “clinical trial mode”, to have more options for vaccinations, especially in cases of infection by mutant strains.
But the use of clinical trial mode has raised questions.
Unfair to accuse us of inexperience, Covaxin Phase-3 efficacy data by March: Bharat Biotech Chairman Krishna Ella
Krishna Ella, Chairman and Managing Director of Bharat Biotech, on January 4 said he didn't know what the regulator meant when it accorded approval under ‘clinical trial mode’, the first such approval.
He said he was in the process of getting more clarity from the drug regulator.
Bhargava hasn't provided clarity, on whether those who may suffer from serious adverse event due to vaccine are eligible for getting compensation, like participants of clinical trials.