While the first vaccine globally to go into human trials, developed by US-based Moderna Inc. is still in its second phase, The Indian Council of Medical Research(ICMR) steps ahead to launch the COVID-19 vaccine ‘Covaxin’ by 15 August.
Balram Bhargava, director of ICMR has written to Bharat Biotech India Ltd (BBIL) to expedite the clinical trials for their jointly developed COVID-19 vaccine ‘Covaxin’ ready for launch by Independence Day on 15 August. The move could potentially raise several ethical questions on the safety and efficacy of the vaccine.
ICMR has received sharp criticism from the scientific community over its nearly impossible launch deadline of 15 August, there is an air of doubt regarding safety issues of the vaccine.
AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, said, “It will be a very challenging and difficult task, considering that we have to look at both efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine”.
Shaheed Jameel, a virologist and chief executive of the Wellcome Trust-DBT Alliance that funds health research in India said August 15 timeline was “ridiculous”.
“I fear the global scientific community would be laughing at us for this. It should not have happened. India is a serious player in science. Who is going to trust us if we behave like this? Who is going to believe us even if we indeed come up with a good vaccine tomorrow?… And I am appalled at the kind of language used in the letter. It is not a letter, it reads like a threat,” Jameel said.
Bhargava on his letter to BBIL, strictly advised fasting track all approvals related to clinical trials of the vaccine get the test subjects ready by 7 July.
The trials are to be conducted at 12 volunteer institutes, which includes All India Institute of Medical Sciences in Patna and Delhi, Institute of Medical Sciences and SUM Hospital in Odisha, Research Centre in Tamil Nadu, Gillukar Multispeciality Hospital in Nagpur, Jeevan Rekha Hospital in Belgaum, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad, PGIMS in Rohtak, Rana Hospital and Trauma Center in Gorakhpur, Redkar Hospital and Research Centre in Goa, and SRM Hospital & Prakhar Hospital in Kanpur.
According to information on the administration’s clinical preliminary library, just five of the 12 institutes have so far got the endorsement from their ethics committee groups. The two-stage study is scheduled to be directed on 1,125 subjects.
The vaccine developing candidates other than the Moderna is the University of Oxford and AstraZeneca plc. They have developed until phase 3, but even that is expected to be ready not before the end of this year.