AIIMS to start Covaxin trial this week
AIIMS, one of the 12 approved sites in the country for conducting early human clinical trials on vaccine candidates, on Saturday received approval of the institute ethics committee to begin the trial.Updated: Jul 20, 2020, 16:00 IST
Five healthy volunteers are likely to receive the first shot of Bharat Biotech’s anti-coronavirus disease (Covid-19) vaccine candidate, Covaxin, by this weekend at the All India Institute of Medical Sciences (AIIMS), New Delhi.
AIIMS, one of the 12 approved sites in the country for conducting early human clinical trials on vaccine candidates, on Saturday received approval of the institute ethics committee to begin the trial.
“The ethics committee has granted its approval for the trial. Recruitment of healthy volunteers will begin from Monday,” confirmed Dr Randeep Guleria, director, AIIMS.
In just 24 hours after having sought applications from people willing to be volunteers for the trial, the hospital received 1,000 applications against its requirement of 100 volunteers.
“The response has been tremendous. Our phone has not stopped ringing since we publicized the number, and of the 1,000 applications 400 queries have come just through emails. We have already replied to each email but people also connected through text and WhatsApp messages which will take longer to reply to. We have stopped taking applications and have started inviting people for the screening process,” said Dr Sanjay Rai, professor, community medicine, AIIMS.
Dr Rai is the principal investigator for the study in AIIMS.
“We applied for the ethics committee’s approval on June 30; they suggested a few things and raised a few concerns for safety that needed minor changes to be made in the trial protocol. Those gaps were addressed and we finally got the approval on Saturday. The registration and screening process of the volunteers will begin from Monday. The entire subject recruitment process is likely to finish in about two weeks,” said Dr Rai.
The applications will need filtering, and applicants will be made to undergo a battery of tests before qualifying for the trial, as the volunteers need to be healthy adults between 18 and 55 years.
“We have called a select number of people on Monday to take their naso-pharyngeal swab and blood sample, to ensure they are Covid-19 negative. Also, they should have no co-morbidities (known or unknown) such as hypertension, diabetes, abnormal kidney or liver function etc. for which we would require them to undertake certain tests. After first screening is complete and test results are out, we should be able to inject the first batch any day between Thursday and Saturday,” said Dr Rai.
The investigators intend to inject at least five selected people in a day.
“Five is what we are looking at, but it will not go beyond 15 volunteers in a day. It will be too premature to say when the results will start showing. The process takes its time,” said Dr Rai.
Covaxin has been jointly developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited.
The virus strain for Covaxin was isolated at ICMR-National Institute of Virology in Pune, and transferred to the company on May 9.
The Drugs Controller General of India granted approval for Phase I and II human trials for safety and efficacy of the vaccine candidate on June 29.
“…. Covaxin initiated phase-1 clinical trials across the country on 15th July 2020. This is a randomized, double-blind, placebo-controlled clinical trial in 375 volunteers in India,” the company said in a statement on Saturday.
Apart from Covaxin, the other indigenous vaccine candidate, ZyCov-D, that has received drugs controller’s nod for early human trials is from pharma company Zydus. The human trials for ZyCov-D began last week.
Experts say eventually it is a vaccine that will work in breaking the Covid-19 transmission cycle.
“Government has taken several steps such as bringing in lockdown to ensure the disease spread is curtailed. The vaccine, however, is going to be the ultimate tool in our fight against the disease. A good vaccine is the most cost-effective way of preventing a disease,” said Dr Amita Jain, head, microbiology department, King George’s Medical University, Lucknow.