India begins human trials of Covaxin, its first homegrown Covid-19 vaccine

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India has begun human trials of its first domestically developed coronavirus vaccine, as a spike of 40,000 new Covid-19 cases in the past 24 hours took the infection tally past 1.19 million people.

The Indian Council of Medical Research, the country’s top clinical research agency, gave the green light to phase I and II human trials of Covaxin, the experimental vaccine developed by Bharat Biotech.

The council’s media coordinator, Lokesh Sharma, said approval was given to 12 separate hospitals, which will decide when and how to launch their individual trials with healthy volunteers.

“Trials at some sites began yesterday or before, at some places it will begin today and at some sites it will start tomorrow,” Sharma told RFI.

Bharat Biotech developed Covaxin in partnership with the Council and the National Institute of Virology.

The Delhi-based All India Institute of Medical Sciences (AIIMS) began the exercise on Monday with 100 of the 375 volunteers enrolled with the 12 pre-selected hospitals for the phase-I trial.

Safety first

“We are starting the phase-1 of the trial,” AIIMS director Randeep Guleria told a news conference and added more people will be added later on, adding that safety was the priority.

“A second dose will be given after 14 days and then we will collect blood samples after various intervals and we will decide, based on the analysis, what is the effectiveness of this vaccine,” Sharma told local media.

He said the first phase would aim to test the vaccine’s safety.

Earlier this month, the research council triggered disbelief by setting 15 August as a deadline for the launch of home-grown vaccine.

Later it backtracked saying the instruction was aimed at speeding up the trials.

Even if fast-tracked, each phase of the trials can last months.

Serum Institute, another Indian biotechnology firm, said it was looking at August to start human trials of a Covid-19 vaccine developed by Oxford University and Astrazeneca, a British-Swedish pharmaceutical company.

Global leader

“We are hoping that the vaccine will be available towards the end of this year," Institute CEO Adar Poonawalla told PTI news agency.

“We have associated with multiple institutions worldwide as manufacturing partners for vaccine candidates that are being developed,” he said.

The Institute is also developing a live attenuated vaccine with Codagenix, a US-based firm.

India meets 62 percent of the global demand for vaccines.

Besides Bharat Biotech and Serum Institute, five more Indian companies are in the race to develop a vaccine against coronavirus.

But Bhramar Mukherjee, an epidemiologist at the University of Michigan, had a word of caution.

“We have to be mindful that we are thinking the vaccine is the solution but even after it's developed…vaccinating a substantial portion of the population is going to be take a long time,” Mukherjee told India Today TV station.

“There is no magic solution” she said.

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