A leaked letter has revealed that the India’s topmost clinical regulatory body, the Indian Council of Medical Research (ICMR) envisages to launch a vaccine for the novel coronavirus by 15th August, Indian Independence Day.
Dozens of vaccine candidates around that world are at various stages of development. In India, biotechnology brand Bharat Biotech with ICMS is leading the nation’s race for vaccine after recently bagging nod for Phase I and II clinical trials on humans, the first in the nation.
The leaked letter, now confirmed authentic, was widely circulated on Friday and it comes from the office of the Director-General of ICMR. A part of it reads: “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.” The letter was addressed to the institutions involved in the trial including Bharat Biotech and was dated July 2nd.
The letter is a clear push to the institutions involved in vaccine development in India. News agency Reuters noted that the first and second phases of clinical trials test the safety of the concerned vaccine on humans, while the final and Stage III clinal trials establish the efficacy. Trails in different phases can take months if not years. Even after scientists fast-tracking the trials the time-frame in the leaked letter is ‘unprecedented,’ Reuters reports.
Experts have raised ethical concerns over the push to land a vaccine by a stipulated time.
“To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries,” Dr. Anat Bhan, a professor, and public health researcher wrote on Twitter. “Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to the process.”
He also pointed out that the tone of the letter is coming up as a threat where it mentions “Get everything done by 07 July (in a letter dated 02 July) and start clinical trial participant recruitment.”
However, the letter also mentioned that BBIL (makers of COVAXIN) is working ‘expeditiously’ to meet the target, “however the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” the letter reads.
The global coronavirus infections have been racing to touch the next million, from the current 10,906,882 confirmed cases globally. The majority of the infections are from the two Americas, with the USA leading. India’s current number of cases is 625,544 according to a tally kept by the Johns Hopkins University.