AIIMS, Delhi and King George Hospital, Visakhapatnam are yet to give the go-ahead to conduct trials for the indigenously developed COVID-19 vaccine, COVAXIN. This comes as a setback for the Indian Council of Medical Research, better known as ICMR, India’s apex medical research body which has long been pushing to launch said vaccine by August 15.
Who is making COVAXIN?
A privately-owned pharmaceutical firm, Bharat Biotech and ICMR stated that they had intended to introduce COVAXIN for health service use by 15 August 2020 at the latest. The National Institute of Virology at ICMR has joined hands with Bharat Biotech to develop a SARS-CoV-2 vaccine, which is the virus that causes COVID-19.
What is the problem with COVAXIN?
New Delhi’s All India Institute of Medical Sciences’ ethics board has noticed inconsistencies in the procedure proposed for trials, posing concerns about whether many places registered for the experiments have their ethics committees’ permissions.
The Phase II study would include respondents in the age range of 12 to 65. That being said, children’s affirmative contract to partake in the research study is lacking. This being a basic requirement raises many questions as to why other ethics committees did not flag the discrepancy.
Apart from AIIMS, the King George Hospital in Visakhapatnam has also delayed providing approval to protocols for the clinical trials of the Covid-19 vaccine from Bharat Biotech. It is well known that the Vizag Hospital’s ethics committee demands the best standards and goes through proposals word by word. It has been found on investigation that their ethics committee will hold a meeting and if any issues are found, said proposal will be sent back to the sponsor.
The trials can not proceed without the required ethics commission’s permissions. From the 12 establishments selected to conduct the trials, five ethics commissions are currently reviewing the nature of the trials. The protocol ‘s absence of the child consent papers, as revealed by AIIMS, the country’s leading clinical institution, may further impede the trials.
What is the current progress?
The vaccine candidates’ first three lots were sent for sterility testing last Friday, a process usually requiring at least 14 days, before which it can not be administered for trials.
Vaccine specialists in the country call for a particular framework for firms to hinge their progress of the Covid-19 vaccine as firms scramble through with their development.
Last week, the US FDA released recommendations for COVID vaccine developers specifying health, effectiveness, and consistency adaptive testing as requirements for the vaccine’s emergency approval. The Indians regulators have been advised to look at these guidelines to come up with proper guidance for their own companies.
Balram Bhargava, Director-General of the ICMR, addressed Bharat Biotech’s Chairman and Managing Director Krishna M Ella and Executive Director V Krishna Mohan on July 2, urging them to “fast track” drug testing of vaccine contender COVAXIN.
The prospect of making a COVID-19 vaccine available for general use by August 15 had raised questions over possible blunders due to the rush in clinical testing.
Since then, however, ICMR has insinuated it’s only primarily directed at completing the clinical trials of the COVID-19 vaccine as quickly as practical, and August 15 is now a deadline.