India begins human trials of Coviaxin, hoping for Covid-19 vaccine success

Private and state-owned hospitals will test the potential vaccine on volunteers, aged between 18 and 55

Human trials for Covaxin, one of the first potential vaccines developed in India in the fight against Covid-19, is underway in 12 centres across the country.

Covaxin is derived from a strain of the SARS-CoV-2, the virus that causes Covid-19, and it was isolated at the Pune-based National Institute of Virology (NIV). The Indian Council of Medical Research (ICMR) and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received approval for phase-I and phase- II human trials by the Drug Controller General of India (DGCI).

The ICMR had identified 12 clinical trial sites such as medical institutions and hospitals like AIIMS, NIMS, and others.

All India Institute of Medical Science (AIIMS)-Delhi on Monday began recruiting volunteers for conducting human clinical trials of Covaxin, the premier medical institute's director Dr Randeep Guleria said.

He also said that there is not much evidence of community transmission of Covid-19 happening at the national level.

AIIMS-Delhi is among the 12 sites selected by ICMR for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.

In phase I, the vaccine would be tested on 375 volunteers and 100 of them, the highest, would be at AIIMS. The second phase, would include around 750 volunteers from all 12 sites put together, Guleria said while addressing reporters.

Phase I of the vaccine trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be selected to be a part of the trial in the first phase, he said.

In the second phase, 750 people will be recruited and they will be between 12 and 65 years of age, Guleria said.

Already, around 1,800 people have registered for the trial at AIIMS, he said.

"In the first phase, we see the safety of the vaccine which is of primary importance and the dose range is also calculated," the AIIMS-Delhi director said.

"In the second phase, we see how immunogenic it is and that is subsequently followed by phase III, which involves a larger population to assess its efficacy and therapeutic benefit", Guleria said.

To a question, he said there is not much evidence of community transmission of Covid-19 happening at the national level. "But there are hotspots, even in cities where there is a spike in cases and it is likely that local transmission is happening in those areas," Guleria said.

States prepare for trials

Goa Chief Minister Pramod Sawant has said that the human trials of coronavirus vaccine have begun at the state's Redkar Hospital and congratulated the team behind it.

"Human trials of Covaxin, an indigenously developed vaccine for Covid-19, has begun at Redkar Hospital in Goa. This is a testimony of India's immense potential in healthcare innovation. My best wishes to the entire team working on Covaxin," Sawant tweeted on Monday.

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In Bhubaneswar, a trial unit was inaugurated at the Institute of Medical Sciences and SUM Hospital on Monday, ahead of the commencement of the human clinical trials.

Professor G Sahoo, dean of the Bhubaneswar hospital, told ANI that close to 30-40 candidates will be chosen for the first phase of the human trials which will commence from July 22.

"Recruitment and screening of volunteers have already started. After screening, we will select healthy individuals between the age of 18-55 for the first phase of trials. We will start the first phase of human clinical trial of the Covid-19 vaccine from Wednesday, after that volunteer will be in contact with us for two to three months," Sahoo told ANI.

"We will monitor those candidates and they will be in constant touch with us. We will also call them here to test the antibody level in their blood after taking the vaccination if it found adequate, then we will go for the second and then for the third phase," he added.

In Hyderabad, the Phase-1 human clinical trials for Covaxin began at the state-run Nizams Institute of Medical Sciences (NIMS) on Monday. 

"We started phase-1 human clinical trials today. The vaccine was given to two volunteers. Both of them are stable", a doctor, associated with the exercise, said.

The process for conducting the clinical trials for Covaxin began on July 7 at the NIMS. It has also been started at Rohtak's Post-Graduate Institute of Medical Sciences last week.