In a move that has raised ethical questions, the Indian Council of Medical Research (ICMR) has asked Bharat Biotech India Ltd to expedite the clinical trials for their jointly developed covid-19 vaccine “Covaxin” to be ready by next six weeks to be launched on an Independence Day.
It was only on Monday, the DCGI had approved the company’s application to conduct the phase I and II clinical trial of its vaccine candidate.
In his letter written on July 2, ICMR Chief Dr Balram Bhargava, urged the institutions, specifically 12 hospitals and research centres around the country, to begin enrolling participants for the clinical trial no later than July 7, and to have the vaccine ready for “public health use”, which presumably means use by doctors, by August 15.
Currently, there are around 150 vaccine candidates in trial across the world. The first vaccine globally that went into human trials was US-based Moderna Inc’s RNA vaccine in April, and the vaccine is still in its second phase.
However, Dr Balram Bhargava sounded as a man in the haste. The ICMR chief said, “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 enrollment is initiated no later than 7 July 2020.”
“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 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,” said the letter written to Bharat Biotech chairman and managing director Krishna Ella and senior vice-president Krishna Mohan.
Incidentally, just two days ago Bharat Biotech chairman and managing director Krishna Ella had told TV channel that he could expect to launch the vaccine only by year end at the earliest and that too if the government waved off the mandatory third stage trial.
But Bhargwa has directed the company to start the trials latest by Tuesday and complete the trial to get the vaccine ready for launch by August 15.
“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 7 July 2020,” Bhargava said.
The vaccine candidate was the first to get the Drug Controller General of India’s approval to conduct clinical trials.
The indigenous, inactivated vaccine was developed in Bharat Biotech’s facility located in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India this month, the company had said on Monday.
The DCGI had on Monday approved the company’s application to conduct a phase I and II clinical trial of its vaccine candidate ‘Covaxin’, which it developed in in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).
The trials are slated to be conducted at 12 institutes--All India Institute of Medical Sciences in Patna and Delhi, Gillukar Multispeciality Hospital in Nagpur, Institute of Medical Sciences and SUM Hospital in Odisha, Jeevan Rekha Hospital in Belgaum, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad, PGIMS in Rohtak, Prakhar Hospital in Kanpur, Rana Hospital and Trauma Center in Gorakhpur, Redkar Hospital and Research Centre in Goa, and SRM Hospital & Research Centre in Tamil Nadu.
There are a number of ethical concerns being raised over the trials -from getting approval from ethics committees for the dozen institutes and starting enrollment of participants within a week to pre-determining the result of the trial for a launch in less than 45 days.
As per data on the government’s clinical trial registry, only five of the 12 institutes have so far received approval from their ethics committees. The two phase study is slated to be conducted on 1,125 subjects.
“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. Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process,” Anant Bhan, a researcher and past president of the International Association of Bioethics, tweeted.