COVID-19 vaccine (COVAXIN): ICMR defends Aug 15 deadline; sa
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A day after the August 15 deadline for a COVID-19 vaccine created controversy over the safety and efficacy of the product, the ICMR got into defensive mode and said that the order to fast-track clinical trials was to cut “red tape”.

On July 2, in a letter to the 12 hospital sites, as well as Bharat Biotech, the ICMR said that there were plans to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials. The letter asked them to recruit human participants for the trial by July 7.

In a bid to clarify its position on the issue, the ICMR said: “Just as the red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement.”

The ICMR said while feedbacks in the public domain from commentators are welcome, the best of Indian medical professionals and scientists "should not be second-guessed" for their professionalism.

The ICMR has also said that the trials would follow best practices and rigour and would be reviewed by a data safety and monitoring board, too, and international norms would be followed.

Also read: https://www.plexusmd.com/md/post?pfpid=55944

Source: https://www.theweek.in/news/health/2020/07/04/covid-19-vaccine-icmr-defends-aug-15-deadline-says-it-was-to-cut-red-tape.html
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