Human clinical trial of COVID-19 vaccine candidate 'Covaxin' begins at Odisha hospital

The much-awaited trial of BBV152 COVID-19 vaccine or Covaxin commenced at the Institute of Medical Sciences and SUM Hospital.
'COVAXIN' was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley.  (Photo| Special Arrangement)
'COVAXIN' was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley.  (Photo| Special Arrangement)

BHUBANESWAR: Five persons in the age group of 18 to 55 were administered the first dose of India’s indigenous coronavirus vaccine Covaxin as the first-phase trials commenced at SUM hospital here on Monday.

The volunteers were administered 0.5 ml intramuscular injection and were monitored for a few hours before being discharged. None of them have yet shown any adverse incident. The candidates are now staying with their families at home but constantly monitired.

"No side effects were observed in the people who have been vaccinated so far. They have been advised to take all the precautions like before - wear masks, maintain hand hygiene, and avoid crowded places," said Dr E Venkat Rao, Principal Investigator of the trials at SUM Hospital.

The second dose will be given after two weeks. Prior to the commencement of trial, all the candidates were screened thoroughly following the vaccination protocol. "They are all healthy human beings without any ailment. The phase I trial, mainly involving heal thy candidates, is conducted to rule out side effects," the researcher said.

If any of the candidates suffer adverse events or ailments due to the vaccination, they would be treated under the medical insurance scheme provided by the vaccine sponsor. But the cover will be withdrawn in case the symptoms are not caused by the vaccine shots.

Meanwhile, the institute has been receiving large umber of queries from people willing to volunteer for the vaccine trial. Those interested to volunteer for the project can register at ptctu.soa.ac.in under the section register for clinical trials.

The phase I trial of Covaxin, developed by Bharat Biotech, will be completed only after 375 people receive both the doses across the country. "Once the number is reached, we will stop for analysing results before going ahead with the phase II trials. So, it’s too early now to say when the second phase will begin," Rao stated.

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