ICMR’s Aug 15 deadline to vaccine maker stirs a row

ICMR’s Aug 15 deadline to vaccine maker stirs a row

Council: Only Meant To Speed Up Process

Sushmi.Dey@timesgroup.com

New Delhi:  04.06.2020

An Indian Council of Medical Research letter which sought fast-tracking of approvals relating to clinical trials and spoke of the launch of a vaccine by August 15 stirred the medical and scientific community on Friday, with questions being asked on how such deadlines could be adhered to given the complexity and time required for trials on humans.

A vaccine candidate by Bharat Biotech received approval to enter initial phases of human clinical trials only earlier this week. In a letter to Bharat Biotech and chosen hospitals for trials, ICMR director general Balram Bhargava 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” in view of the public health emergency and “urgency to launch the vaccine”.

Belagavi hospital set for ‘mission Aug’

Jeevan Rekha Hospital in Belagavi is among 12 institutions selected by ICMR to fasttrack clinical trial approvals for indigenous Covid-19 vaccine candidate — Covaxin — reports Shreyas HS.

Hospital director Amith S Bhate said he was informed two days ago. “We are ready to complete the mission by August,” he said, adding that confirmation from the state government is awaited. P 2

‘Vaccine timeline unrealistic’

ICMR has partnered with Bharat Biotech to develop a vaccine called Covaxin.

Official sources said the health ministry had asked ICMR about the letter and was informed that the objective was to speed up the processes relating to vaccine development rather than set any hard deadlines.

"We need the vaccine at the earliest and that was what ICMR wanted to convey," a source said. ICMR officials also told TOI that no deadlines were being set.

However, the tone of the letter, suggesting that noncompliance will be treated seriously, generated concern over whether processes were being rushed. "It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project," Bhargava said in the letter dated July 2.

The content of the letter mainly suggested a timeline and the accent was to stick to it, but some experts called it "unrealistic" and even "unethical". Health experts also raised concerns about ICMR’s role as a co-creator of the vaccine and also attributing timelines resulting in a "conflict of interest".

Zydus vaccine gets DCGI nod for trials

Ahmedabad: Pharmaceutical and healthcare major Zydus Cadila has received approval from the Drug Controller General of India (DCGI) and Central Drugs Standard Control Organisation (CDSCO) to start Phase I and II human clinical trials in India of its vaccine candidate for Covid-19. Called ZyCoV-D, it is a plasmid DNA vaccine candidate for Covid-19. Zydus Cadila is the second company, after Bharat Biotech, to have received regulatory permission to conduct human clinical trials for a potential Covid-19 vaccine. TNN