Home >News >India >ICMR presses for covid vaccine Covaxin launch by August

India is seeking to accelerate the development of its own vaccines for covid-19 with two local companies set to commence clinical trials for their indigenously developed vaccine candidates.

State-run vaccine maker Bharat Biotech India Ltd has been asked by the Indian Council of Medical Research (ICMR) to “fast track" clinical trials of its covid-19 vaccine Covaxin, setting it a launch deadline of 15 August.

The ambitious six-week deadline leading up to Independence Day, which became known on Friday from an internal communication reviewed by Mint, has surprised medical scientists, who fear it may prompt a rush job.

The order by Balram Bhargava, ICMR director general and health research secretary, came in a letter to Bharat Biotech chairman and managing director Krishna Ella and senior vice-president Krishna vice-president Krishna Mohan on Thursday.

“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials. BBIL (Bharat Biotech) is working expeditiously to meet the target; however, the final outcome will depend on the cooperation of all clinical trial sites involved," said Bhargava.

He directed the company to start the trials latest by Tuesday. “In view of the public health emergency 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 7 July 2020," Bhargava said.

He said the vaccine is the biggest priority for the government and is being monitored at the highest level. “Kindly note that non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse," Bhargava wrote to the Bharat Biotech officials.

A spokesperson for ICMR confirmed the authenticity of the letter but declined to elaborate. Bharat Biotech declined to comment on the letter. Calls to Krishna Ella’s mobile phone went unanswered.

Ahmedabad-based Zydus Cadila Healthcare Ltd on Thursday became the second company to receive the nod from the Drugs Controller General of India ( DCGI) to start human clinical trials for its indigenously developed vaccine candidate. Zydus said in a statement on Friday that its vaccine contender, ZyCoV-D, showed a “strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, according to a PTI report.

Over seven vaccines are currently being researched in India with two receiving the nod for human trials.

DCGI had on Monday approved Bharat Biotech’s application to conduct a phase I and II clinical trials of its vaccine candidate, ‘Covaxin’, which it has developed in collaboration with the ICMR’s National Institute of Virology (NIV). The vaccine candidate was the first to get the DCGI’s approval for clinical trials.

The indigenous, inactivated vaccine was developed in Bharat Biotech’s facility in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India this month, the company had said on Monday.

“In order to speed up things, they have to provide all kinds of facilities and support but they can’t threaten them (Bharat Biotech) with dire consequences," Amar Jesani, an independent bioethics consultant, said.

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