ICMR asks 12 hospitals to fast track clinical approvals for 'COVAXIN' trials as India's COVID-19 tally crosses 6.25 lakh

The target set by the government to complete the trials by August 15 however was dubbed as 'next to impossible' by many including some principal investigators chosen for the project.
Plasma donors at Delhi Plasma Bank in the Institute of Liver and Biliary Sciences on Thursday July 2 2020. (Photo | Shekhar Yadav, EPS)
Plasma donors at Delhi Plasma Bank in the Institute of Liver and Biliary Sciences on Thursday July 2 2020. (Photo | Shekhar Yadav, EPS)

NEW DELHI: In a massive development, Indian Council of Medical Research has written to 12 hospitals across 10 states asking them to fast track clinical trials approvals for a COVID-19 vaccine candidate developed by Bharat Biotech in order to launch the vaccine for public use by August 15.

The apex health research body also asked hospitals to enrol volunteers for the trials by July 7. Sources told this newspaper that nearly 1300 patients will be enrolled for the project in AIIMS, Delhi alone pointing out that early human trials are usually held with much smaller numbers to test for efficacy and safety of a potential vaccine. 

The development comes just days after Hyderabad based BBIL received permission from the Drug Controller General of India to begin phase 1 and 2 trials in humans for its vaccine candidate Covaxin after pre-clinical trials in three animals showed encouraging results.

The vaccine candidate has been prepared from SARS CoV 2 strain isolated at the ICMR’s National Institute of Virology and is inactivated virus. The results of the pre-clinical trials however have not been published yet.

In the letter sent out to hospitals-some of them are major likes AIIMS, New Delhi with the best research credentials but also small set ups with no established track record of major research- ICMR director general Dr Balram Bhargava said that Covaxin is “one of the top priority projects which is being monitored at the topmost level of the government.”

“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials,” said the letter issued on Thursday adding that BBIL is working expeditiously to meet the target, however final outcome will depend on the co-operation of all clinical trial sites.

ICMR issued a brief statement saying that "the letter has been sent out to request fast-tracking of the vaccine trials." 

The target set by the government however was dubbed as “next to impossible” by many including some principal investigators chosen for the project.

“You have been chosen as a clinical trial site of BBV152 Covid vaccine. 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 the approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than 7th July 2020,” the directive said.

It warned that “non-compliance will be taken very seriously”. “Therefore you are advised to treat this project on highest priority and meet the given timeline without any lapse.”

A query seeking a response from the ICMR on the warning tone of the letter has remained unanswered but health policy experts questioned the near “arm-twisting of hospitals” for fast tracking.

“I don’t know how is it possible to launch a vaccine in little over a month which has not even entered phase 1 and 2 trials,” said Anant Bhan, a specialist in global health and bioethics. “Also, I think that many sites chosen for the project won’t even have ethics committees approved by the drug regulator and have no prior experience of carrying out a clinical trial for vaccines.”

Meanwhile, in an interview given to this paper on Thursday, BBIL CMD Dr Krishna Ella had said: “At the moment we are not sure how the vaccine is going to perform in humans, as clinical trials are about to start.

“Based on the successful results of phase 1 and phase 2, we will progress to the larger clinical trials,” he had said.

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The New Indian Express