A medical worker performs Covid-19 testing. | Photographer: Gabriella N. Baez | Bloomberg
A medical worker performs Covid-19 testing | Gabriella N. Baez | Bloomberg File photo
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New Delhi: Privately-run diagnostics chain Dr Dangs Lab in the national capital has been selected as the central lab for the human clinical trials of Covaxin, an indigenous Covid-19 vaccine being developed and manufactured by Bharat Biotech in collaboration with the country’s apex health research body, Indian Council of Medical Research (ICMR).

Dr Dangs Lab told ThePrint that it has already started receiving samples from 50 to 100 prospective subjects per day from 12 clinical trial sites, including the All India Institute of Medical Sciences (AIIMS), Delhi, for screening and safety testing.

The lab is processing all samples for screening and safety for the various phases of this clinical trial, whereas the efficacy studies will be performed at National Institute of Virology, Pune.

The trial sites are conducting a randomised, double blind, placebo-controlled multi-centric clinical trial to test Covaxin.


Also read: T cells produced, mild side effects — decoding why Oxford’s vaccine offers new Covid hope


Kickstarting a clinical trial

Arjun Dang, CEO of Dr Dangs, said his facility was chosen by Bharat Biotech given its location and and quick turnaround time.

“We are chosen because of the quicker turnaround time. We are located in Delhi and receive samples from all over the country. We have a robust clinical trials and logistics team that takes care of that,” the CEO said.

To begin the process, Dang said the lab was screening samples to check a candidate’s eligibility to participate in the trials.

“We have started screening the participants to understand who is eligible to receive the vaccine. Screening is the first step towards enrolling participants for vaccine trials, where one sees who is fit to be a subject,” Dang said.

“Post screening, one selects the participants and post that one starts the dosing of the vaccine in the human subjects,” he added.

Sources in Bharat Biotech said up to 40 human volunteers have already been enrolled for the trials across various sites after screening, and dosing has started too. This means that they have already been administered doses of the vaccine.

“While ICMR’s National Institute of Virology, Pune is checking the efficacy of the vaccine and the immune response it produces, we at Dr Dangs are checking how safe the vaccine is. We will be the central lab to conduct screening and safety studies of all the participants throughout all the phases of the clinical trials,” Dang said.

Earlier this week, AIIMS, Delhi, said it had begun recruitment for the trial. Institute director Dr Randeep Guleria said all trial sites combined will have a total sample size of 1,125 healthy volunteers.


Also read: Why we should not hype the hope for the Oxford-AstraZeneca Covid vaccine


 

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