Many medical experts and top scientists in the country have called out the Indian Council of Medical Research (ICMR) for a previous letter that sought production of Coronavirus vaccine for public use by August 15.
Coronavirus vaccine in India update: Many medical experts and top scientists in the country have called out the Indian Council of Medical Research (ICMR) for a previous letter that sought production of Coronavirus vaccine for public use by August 15. It is believed that the timeline set by the council is “absurd” and “unreasonable”. To this, ICMR has justified that the deadline mentioned earlier for clinical trials was only written to “cut unnecessary red tape,” The Indian Express reported. It added that the aim for mentioning the timeline was to complete all the phases of trials as soon as possible without any delay.
The statement issued by ICMR DG had clarified that the council meant to speed-up the process and not let red tape become a hindrance, thus leading to fast-tracking of approvals instead of the slow movement of files. The idea is similar to how the council did not allow the red tape to become a barricade in quick approvals of new indigenous testing kits or the introduction of new COVID-19 medicines in the Indian market, the report mentioned, citing ICMR as saying.
It is to note that the initial letter written by ICMR director general Balram Bhargava said that the subject enrollment has to be initiated by July 7 and the approvals for clinical trials have actually been given on June 29 this year.
The letter written by Bhargava, the report highlighted, has concerned many experts and triggered an outrage. AIIMS Director Randeep Guleria told the IE that the deadline set by the ICMR is quite challenging and difficult to do as the trials have to be done keeping in mind the efficacy and safety of the vaccine. Apart from this, Guleria said that mass production still remains a challenge.
The potential vaccine in India is being made by Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with Pune-based National Institute of Virology, an ICMR laboratory. According to the report, a meeting which was likely to be held with the principal trial investigators has been postponed. Further, citing WHO Chief Scientist and former ICMR head Soumya Swaminathan, the report said that the first phase trials of this vaccine have not started yet and it cannot be given to the public by August 15.
The World Health Organisation (WHO) has recommended the trials especially phase three trials of vaccination should ethically involve 20-30,000 people, which according to Swaminathan would take a long time.
Bharat Biotech, in a background note circulated, stated that the first two phases of clinical trials of Coronavirus vaccine cannot be out before October. The approval for both of the phases by the institutional ethics committees from at least half of the 12 selected hospitals is yet to come before the company can begin the trial. While ICMR has given a timeline of five and a half weeks for clinical trials, the vaccine which is being developed will need one year and three months.