Following globally-accepted norms, says ICMR over August 15 vaccine target
The Indian Council of Medical Research (ICMR) on Saturday said that it is acting in accordance with globally-accepted norms by setting a mid-August target for developing a COVID-19 vaccine. The health body had been facing criticism, even from medical experts, who doubted that the process could be completed in the next six weeks. Here are more details.
In a statement on Saturday, the ICMR said that it is acting in accordance with the globally-accepted norms to fast-track vaccine development for diseases of pandemic potential. The health body also underlined that it was among the world's most reputed medical research organizations and "the best of India's medical professionals and research scientists should not be second-guessed for their professionalism."
The statement said, "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." It added, "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."
"While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India's medical professionals and research scientists should not be second-guessed for their professionalism or adherence to the highest scientific rigor."
On June 29, the Drug Controller General of India (DCGI) has cleared COVAXIN for human trials. On Friday, Bharat Biotech Managing Director Krishna Ella told The New Indian Express that the vaccine can be expected by early-2021. The ICMR said on Saturday that it was only after in-depth scrutiny that the DCGI had accorded permission to conduct phase 1 and 2 trials.
In a letter dated July 2, ICMR Director-General Dr. Balram Bhargava had asked 12 clinical trial sites to fast-track the vaccine development process for Bharat Biotech's COVAXIN. The ICMR asked principal investigators to ensure that subject enrollment is done by July 7. It also advised the sites to fast-track all approvals for the trial and warned that "non-compliance will be viewed very seriously."
Several experts have since said the ICMR's target seems rushed, even considering the accelerated timelines. Immunologist Satyajit Rath told PTI that the ICMR's letter was "deeply inappropriate letter, in tone and content." CPI(M) General Secretary Sitaram Yechury claimed the ICMR was trying to rush the vaccine development process to allow Prime Minister Narendra Modi to make an announcement on August 15—India's Independence Day.
