With doubts rising over the Indian Council of Medical Research’s announcement of a deadline for Covid vaccine trials, the research institute itself has on Saturday clarified that the vaccine was developed as per globally accepted norms of fast tracking Safety.
Noting that it was important to expedite the clinical trials with a promising indigenous vaccine, the ICMR said that its process was exactly in accordance with the globally accepted norms of fast-track vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.
The ICMR in a release said that all other vaccine candidates across the globe have been similarly fast-tracked. It mentioned that development of an effective vaccine is a promising tool to save lives as the entire world is battling the COVID-19 pandemic.
An inactivated COVID-19 vaccine candidate has been developed by Bharat Biotech International Ltd. in collaboration with ICMR – National institute of Virology, Pune. The ICMR said that it supported the vaccine candidate after intense characterization and review of all data from BBIL. The Institute supported the clinical development as the vaccine candidate appeared to be promising, the release said. IT also stated that the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trial.
The ICMR said that preclinical studies were completed successfully and phases 1 and 2 human trials are to be initiated. It also mentioned that the letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants. It said that the aim was to complete the phases at the earliest, so that population-based trials for efficacy could be initiated without delay.
“Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB),” the ICMR said.
ICMR is committed to treat the safety and interest of people of India as a topmost priority, it said.
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