ICMR pushes for Covid-19 vaccine by Aug 15

The Indian Council of Medical Research which is collaborating with Bharat Biotech International Limited to ‘fast-track’ clinical trials of an indigenous Covid-19 vaccine has ‘envisaged’ its launch for public use by August15, a deadline that has left most experts sceptical. Director General of ICMR Dr Balram Bhargava in a letter to 12 institutes that have been handpicked for clinical trials of the Covid-19 vaccine (BBV152 COVID vaccine), also known as Covaxin, has advised them to ‘fast-track all approvals related to initiation of the clinical trial’ and treat the project as ‘highest priority.’

Bhargava, in his letter dated July 2, has noted that ‘non-compliance will be viewed very seriously’ and has asked the authorities concerned in the institutes to ‘meet the given timelines without any lapse.’ “It is envisaged to launch the vaccine for public health use latest by August 15,2020 after completion of all clinical trials. BBIL 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,” Bhargava wrote in the letter. “In view of the public health emergency due to Covid-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast-track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7, 2020.”

The vaccine has been derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune and the research body along with BBIL are jointly working for its pre-clinical as well as clinical development. A strain of the novel coronavirus was isolated from an asymptomatic Covid-19 patient and transferred to BBIL early in May, which was then used to develop an ‘inactivated’ vaccine at its high-containment facility in Hyderabad.

After receiving approvals for two phases of clinical trials from the Drug Controller General of India, the BBIL on July 1 registered its vaccine candidate for trials.

As per the Clinical Trial Registry of India, BBIL plans to test a total of 1,125 people in these trials and plans the first enrolment of subjects on July 13.

Top sources in ICMR said that while the body is trying to expedite the launch of the vaccine, the letter issued by Bhargava was only a ‘demi-official letter’ (DO letter) that is semi-official in nature. Sources said that as per internal estimate, if the first phase of trial begins on July 13 it could be wrapped up by the end of the month and the second phase could begin in early August and be ready for a launch by August 15. Officials pointed out that the ‘intention is to bring out the vaccine at the earliest’ and the ‘deadline should be viewed as a push in the right direction.’ However, according to the CTRI, the BBIL has estimated the trials to take one year and three months out of which the first phase alone will take at least a month.

Neither ICMR official spokespersons nor DG ICMR Bhargava responded to queries on the feasibility of the early rollout of the vaccine.

Even the most advanced vaccine candidates like the University of Oxford do not anticipate vaccines before the end of the year despite encouraging results so far.

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