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The Indian Council of Medical Research (ICMR) has issued a clarification following criticism over its claim of plan to release a Coronavirus vaccine by 15 August while starting human trials for the same in July. ICMR has said that while it aims to expedite clinical trials of COVAXIN, developed in collaboration with Bharat Biotech, all globally accepted norms for vaccine development will be followed. ICMR has clarified that it has asked the clinical study sites only to cut red tape related to the trial for the Coronavirus vaccine, and not to bypass any clinically necessary step.

Bharat Biotech International Ltd., an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot earlier this week and it already has India’s apex medical research body expediting the process.

The under-development vaccine is “envisaged" to be rolled out “for public health use by Aug. 15 after completion of all clinical trials," Indian Council of Medical Research, or ICMR, said in a July 2 letter to clinical trial sites, which was seen by Bloomberg News. It “is one of the top priority projects which is being monitored at the topmost level of the government."

There’s been no evidence yet that Bharat Biotech’s vaccine is safe for use on humans, not to mention effective. The envisioned timeline is markedly shorter than other front-runner vaccine efforts from American and Chinese drugmakers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.

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Statement issued by ICMR on Covaxin trial

After the growing criticism over particularly the deadline, ICMR in a statement issued on July 4 has clarified that it has asked the study sites chosen for the trial to cut red tape to complete the trial as soon as possible. The medical body also said that all other Coronavirus vaccine development efforts across the globe have been fats-tracked in the similar manner. ICMR has confirmed that it has tried to ensure that the vaccine is not stuck in files, and also will conduct multiple steps in the development process simultaneously, like human and animal trials.

“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked. ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel”, the statement says.