Coronavirus vaccine: Covaxin phase-3 trial commences in Bengaluru hospital

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The Phase-III clinical trial of Covid-19 vaccine -- Covaxin being developed by Bharat Biotech began at the privately-run Vydehi multi-specialty hospital in Bengaluru. Covaxin' is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Chief Minister BS Yediyurappa virtually inaugurated Phase 3 of a clinical trial of Covaxin being developed by Bharat Biotech. The trials will be conducted at Vydehi Institute of Medical Sciences and Research Centre in Bengaluru

"I think they're doing clinical trial on about 1600-1800 people in Karnataka. CM has officially announced & given first dose today through Vydehi institution. I hope 3rd phase will be very successful & will be devoid of adverse effects on any individual," Health Minister K Sudhakar told ANI.

Earlier, Vydehi Institute of Medical Sciences and Research Centre official K. Ravi Babu told IANS. "The ICMR (Indian Council of Medical Research) has permitted our hospital to conduct the third phase trial for Covaxin developed by the Hyderabad-based Bharat Biotech.

The hospital has roped in Clintrac International Ltd for the trials, which will involve about 1,000 volunteers.

Though the volunteers need not stay in the hospital, Babu said they would be monitored daily through phone/video call for feedback and updates.

"The volunteers will be a mix of men and women above 18 years of age. As the vaccine candidate is preventive and curative, it will be given to those who test negative and are asymptomatic," said Babu.

Karnataka Health Minister K. Sudhakar will launch the trial and interact with Biotech's scientists and the hospital's team of doctors who will be evaluating the results.

"The data from the trials will be submitted for analysis by the sponsor team to the state-run Drugs Controller General of India for validation," added Babu.

Sudhakar, a medical doctor by profession, said the trial results would give the efficacy level of the vaccine in January so that it can be produced in large quantities for inoculating as many people as possible in the coming months.

"As decided by the government, Covid warriors, including doctors, nurses, para-medics and all others who are on the frontline in the battle against the virus, will be given the vaccine first. They are about 5 lakh across the southern state," Sudhakar told reporters here.

The vaccine will also be given on priority basis to senior citizens, those who are comorbid and vulnerable sections of society.

Also Read: 'Adverse event' won't halt Oxford vaccine trial: Health Ministry

(With Inputs from IANS)