Clinical trials of the indigenous COVID-19 COVAXIN may be delayed further as multiple institutes, which are selected to hold these trials, still evaluating the process.
At least two hospitals — New Delhi’s All India Institute of Medical Sciences (AIIMS) and Visakhapatnam’s King George Hospital — have still not approved protocols for clinical trials of the indigenous COVID-19 vaccine candidate COVAXIN, according to a report by The Economic Times.
This comes as a setback for the Indian Council of Medical Research (ICMR) which has been pushing for launch of the vaccine by August 15.
ICMR and Bharat Biotech, a private pharmaceutical company, said that they had envisaged COVAXIN to be launched for public health use latest by August 15, 2020. ICMR’s National Institute of Virology and Bharat Biotech are jointly developing a vaccine against SARS-CoV-2, the virus that causes COVID-19.
The ethics committee at AIIMS has reportedly found discrepancies in the protocol submitted for trials of COVAXIN. The phase-II trial will have participants in the age group of 12 to 65. However, the report cites a person familiar with the issue as claiming that affirmative agreement for children to participate in the study is missing.
"This is a basic requirement. Why other ethics committee did not flag this discrepancy needs to be inquired into," the people told the newspaper.
Ethics committee of the King George Hospital in Vizag is expected to hold a meeting on July 7.
Of the total 12 institutes selected to hold the human trials, ethics committees of five are still evaluating the process.
Absence of the child assent document in the protocol, as pointed out by AIIMS could delay the trials further.
Moneycontrol could not independently verify the report.
On July 2, ICMR’s Director-General Balram Bhargava wrote to Bharat Biotech Chairman and Managing Director Krishna M Ella and Executive Director V Krishna Mohan, asking them to “fast track" clinical trials of vaccine candidate Covaxin.
The possibility of having a COVID-19 vaccine ready for public use by August 15 had raised concerns over potential lapses in clinical tests due to the hurry.However, ICMR has since claimed that it only aims to complete the COVID-19 vaccine’s clinical trials as soon as possible, and August 15 is now a deadline.