ET Bureau Last Updated: Jul 07, 2020, 08.31 AM IST
NEW DELHI | MUMBAI: At least two hospitals are yet to approve the protocols for clinical trials of an indigenously developed Covid-19 vaccine, a setback for India's top medical research body, which wants to launch it on August 15. The ethics committee of the All India Institute of Medical Sciences in New Delhi has found discrepancies in the protocol submitted for trials, raising questions on how other sites enrolled for the trials have got approvals from their ethics committees.
The phase II trial will have participants in the 12-65 age group. However, the affirmative agreement for children to participate in the study is missing, people familiar with the matter told ET. "This is a basic requirement. Why other ethics committee did not flag this discrepancy needs to be inquired into," the people said.
King George Hospital in Visakhapatnam has not given the go-ahead for the clinical trials of Bharat Biotech's Covid-19 vaccine.
"The ethics committee will hold a meeting tomorrow (Tuesday) and if they find any issues, it will be sent back to the sponsor. Our ethics committee is very tough;they read every word carefully. This is the basic step," said R Vasudev, assistant professor at King George Hospital. The trials cannot start without approvals from ethics committees. Of the 12 institutes selected to hold the trials, the ethics committees of five are still evaluating the trial design. The absence of the child assent assent document in the protocol, as uncovered by AIIMS, the country's premier medical institute, may hold up the trials further.
The first three batches of the vaccine candidate were sent for sterility tests on Friday, a process that takes at least 14 days, before which it cannot be administered for trials, ET reported in its edition on Monday.
Vaccine experts call for a specific guideline in India for companies to base their Covid-19 vaccine development as companies rush through with their development.
"The Indian regulators can look at the USFDA guideline to come up with their own guidance for companies. We are accelerating timelines, yet it is possible to do a trial with a good design," said Davinder Gill, former CEO of Hillman labs to ET.
The US FDA issued last week issued guidelines for vaccine developers of Covid that lays down criteria for safety, efficacy and quality adaptive trials for emergency approval of vaccines.