The official claim by the Indian Council of Medical Research (ICMR) that it envisaged the “launch” of a Covid vaccine for “public health use latest by August 15” has drawn sharp criticism from the scientific community and sparked fears that its safety and efficacy could be compromised to meet the “near impossible” timeline.
Importantly, the August 15 deadline flies in the face of publicly announced timelines for the possible readiness of this vaccine, including the vaccine developer’s own estimate and the timeline provided to the regulatory body, Drug Controller General of India.
Even AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, seemed surprised.
“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 well-known 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.
Explained: ICMR claims it wants to launch Covaxin by August 15, here’s what you need to know
The August 15 timeline is mentioned in a letter that ICMR director general Balram Bhargava wrote to the 12 hospitals selected for carrying out clinical trials of Covaxin, a candidate vaccine developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, in partnership with Pune-based National Institute of Virology, an ICMR laboratory.
The letter, dated July 2, has created a furore because of the unrealistic timeline, and the language used.
“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials… 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 July 7, 2020,” Bhargava said in the letter, before sounding a warning. “Kindly note that non-compliance will be viewed very seriously.”
The approval for clinical trials had been given on June 29, and no one, not even the company itself, believes that the vaccine will be ready by August 15.
In a background note circulated the day it received approval for clinical trials, vaccine developer Bharat Biotech said that the results of Phase I and Phase II trials would be out only by October.