ICMR asks clinical trial sites of Covid-19 vaccine to fast-track approvals for August 15 launch
Covaxin is the first indigenous vaccine to get clearance for human trials in India.
The Indian Council of Medical Research on Thursday directed clinical trial sites of Covaxin to fast-track approvals, saying that the experimental coronavirus vaccine was the “top priority project” of the government.
“It is envisaged to launch the vaccine for public use by latest August 15th after completion of all clinical trials,” ICMR Director General Balram Bhargava said in a letter sent to the 12 hospitals and medical institutions that are involved in the clinical trials of Covaxin.
Covaxin was the first indigenous vaccine to get a go-ahead for human trials by the Drug Controller General of India, on June 29. It has been jointly developed by a Hyderabad-based private firm Bharat Biotech, the Indian Council for Medical Research and the National Institute of Virology. The first and second phase of its clinical human trials are scheduled to begin from July.
In the letter dated July 2, the ICMR said that Bharat Biotech is working expeditiously to launch the vaccine for public use by August 15. However, the final outcome will depend on the cooperation of all clinical trial sites involved in this project.
“You have been chosen as a clinical trial site of the BBV152 Covid vaccine [Covaxin],” the medical body said. “ln 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 enrollment is initiated no later than July 7.”
The ICMR warned that any kind of non-compliance to the order will be viewed “very seriously”.
Health experts have raised concerns about the letter, questioning the way the ICMR has put pressure on the ethics committees of 12 institutions to approve the trials. “To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries,” said Anant Bhan, bioethics researcher and visiting professor in the Department of Community Medicine, Yenepoya Medical college, Mangalore. “Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process.”
For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July?
— Anant Bhan (@AnantBhan) July 3, 2020
And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?
Also read:
- ‘It’s unscientific’: Doctors entrusted with Covid-19 vaccine trial slam ICMR’s August 15 deadline
- Explainer: Covid-19 vaccine development – and why India has to be a player in this
On Friday, Gujarat-based pharmaceutical company Zydus Cadila said it has received approval from the Drug Controller General of India to start phase one and two human clinical trials of its coronavirus vaccine. The pharmaceutical company said that it has already produced batches of the vaccine candidate and will start the clinical trials across multiple sites in India in July in over 1000 subjects.
No coronavirus vaccine has been approved yet for commercial use anywhere in the world. The World Health Organization’s latest draft landscape of Covid-19 candidate vaccines shows 16 candidate vaccines in clinical trials and 125 candidate vaccines in preclinical evaluation.
One of the leading candidates in terms of timing is the University of Oxford-AstraZeneca Covid-19 experimental vaccine, which is in the stage of human trials.
