ICMR said that the process was 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.
COVID-19 vaccine: The Indian Council for Medical Research on Saturday issued details regarding the fast-tracking of the process of development of the COVID-19 vaccine candidate in India that is being developed by Bharat Biotech International Ltd, saying that the procedure being followed by it is in accordance with the globally-accepted norms, ANI reported.
Issuing the statement, ICMR said that the process was 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.
In times of such an unprecedented COVID-19 pandemic, all other vaccine candidates across the world have also been similarly fast-tracked, ICMR stated.
And further added that in the larger public health interest, it is important for it to expedite clinical trials with a promising indigenous vaccine, reports said.
This comes in the wake of reports that some Indian scientists had raised concerns regarding the sudden traction that India’s COVID-19 vaccine programme has gained.
After ICMR announced that it was targeting a preventive vaccine for Coronavirus by next month, PTI quoted several scientists as saying that it was important to strike a balance between fast-tracking and rushing vaccine development and release — a process that can take months, even years.
The premier medical body had stated that 12 clinical trial sites had been identified for the indigenous Covaxin — that was being developed by a collaboration of the National Institute of Virology (NIV) and Hyderabad-based Bharat Biotech.
In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the #COVID19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked: ICMR https://t.co/gJiGKjZ2ku
— ANI (@ANI) July 4, 2020
ICMR had also asked principal investigators and medical institutions to ensure that by July 7 the subjects are enrolled.
In a letter to the principal investigators of the 12 sites, ICMR Director General Balram Bhargava had written that it was envisaged to launch the COVID-19 vaccine after completion of all clinical trials by August 15.
Pharmaceutical manufacturer Zydus Cadila also announced Friday that it had received permission for human clinical trials for a potential vaccine from the Drugs Controller General of India’s (DCGI).