Ahmedabad: None of the five volunteers, including a woman, who were given a shot each of Covaxin, the Bharat Biotech International Limited’s Covid-19 vaccine, at the Sola Civil Hospital in Gujarat’s economic capital of Ahmedabad, has made any complaint of discomfort so far, a senior doctor said on Friday.
During the phase 3 clinical trials of Covaxin, the first dose of the shot was given to the five volunteers. …..
Dr Parul Bhatt, the medical superintendent of the hospital, said the second dose would be given after 28 days. “Volunteers who’ve been vaccinated have yet not complained of any health issues/symptoms. More will be vaccinated now,” she told the media.
The large-scale phase 3 trials of Covaxin, which is being developed by the Hyderabad-based firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), will recruit over 26,000 volunteers from 25 trial sites across the country.
“In the first phase, we have planned to cover 1,000 healthy volunteers. They must be in the age group of 18 to 60 and with no history of coronavirus infection. Anyone who fulfills the criteria can approach us and enroll as a volunteer,” she said.
She said that doctors at the hospital engaged in the clinical trial exercise would remain in touch with the volunteers over the phone to monitor their health condition after the vaccine was administered. She said the volunteers would be called at the hospital at regular intervals for follow-up procedures and tests, including blood test and oxygen level.
“This whole exercise will continue for 12 months. We will also give a contact number to the volunteers in case they need any urgent intervention. The hospital will provide necessary treatment in case of any complication,” she added.
Ahmedabad’s Sola Civil Hospital is among 130 centres selected across the country for Covaxin’s phase three trials. Bharat Biotech had last week announced the commencement of the third phase trials, the first candidate in India to reach this stage.
(Manas Dasgupta)