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India plans to launch its coronavirus vaccine by August 15. Covaxin, the first coronavirus vaccine for public health will be launched latest by August 15, 2020, once the clinical trials of the vaccine are completed, the ICMR has said. The final outcome of the vaccine will
depend upon the cooperation of all clinical trial sites that are involved with the project, it stated. In a letter, Director General of ICMR, Balram Bhargava said human trials for the coronavirus vaccine, that is being developed by Bharat Biotech and the ICMR, should be
“fast-tracked”.

Ever since this letter came out in public domain, experts have raised ethical and safety concerns over this move to fast-track vaccine development for a disease about which the world is still learning. Experts say that for a vaccine for which pre-clinical development is
still ongoing, how can clinical trial recruitment be starting on July 7 and the vaccine be launched on August 15? They also question the grounds on which clinical trial sites have been chosen as some of these institutes seem to be small nursing homes or hospitals.
Outlining the dangers of fast-tracking the process, an expert said if we roll out a vaccine which harms even one in a thousand person, it still will have terrible effect on public confidence on any Covid-19 vaccine.

Meanwhile, a look at the Clinical Trial Registry of India for human trials of the vaccine that is being developed by Bharat Biotech reveals that the trial was registered on July 1 for Phase 1 and 2 study. The details shows that it plans to test 1,125 people in these
trials and plans to enrol people on July 13. According to the registry, the firm could take one year and three months. Of this, Phase 1 trials alone will take at least a month. This means there is very limited time to look into the safety and efficacy of these trials.

Meanwhile, DCGI has given approval to Zydus Cadila to start Phase 1 and 2 clinical trials of its vaccine. This is the second vaccine after Bharat Biotech Covaxin to get approval for human clinical trials.

The indigenous vaccine being developed in India is one of the top-priority projects which is being monitored at the top-most level of the government. PM Modi had recently held a high-level meeting to take stock on the indigenous vaccine efforts.

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