NEW DELHI :
The Indian Council of Medical Research (ICMR) on Sunday said it has not set a 15 August deadline for a Made-in-India vaccine for covid-19, seeking to allay a controversy over setting a hurried target for the drug.
The apex biomedical research agency said its aim is to complete trials quickly, similar to vaccine candidates in other countries, considering the need to urgently control the coronavirus spread.
“Just as red tape was not allowed to become a hindrance in the fast-track approval of new indigenous testing kits or for introducing in the Indian market potential covid-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement," an ICMR statement said.
ICMR director general and health research secretary Balram Bhargava had on Thursday written to Bharat Biotech International Ltd’s (BBIL’s) chairman and managing director Krishna M. Ella and executive director V. Krishna Mohan, asking them to “fast track" clinical trials of vaccine candidate Covaxin, setting it a launch deadline of 15 August.
Bhargava also “strictly" advised companies to accelerate approvals related to starting clinical trials and ensure that subject enrolment is initiated no later than 7 July.
“Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials," an ICMR official said on condition of anonymity.
The drugmaker has developed Covaxin in partnership with ICMR’s National Institute of Virology, the first candidate to receive approval from the Drugs Controller General of India for clinical trials.
Separately, the Union science & technology ministry issued a statement saying six Indian companies are currently working on a vaccine for covid-19, but none of these vaccines is unlikely to be ready for mass use before 2021.
The statement titled ‘Indigenous Indian Covid-19 vaccines in the global race to end the pandemic’ by Dr T.V. Venkateswaran, a scientist with the department, was later backtracked by removing the 2021 deadline part.
The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay, ICMR said. “Our trials will be done following the best practices and will be reviewed by a data safety monitoring board," it added.