The Phase-3 clinical trials of Covaxin — Covid vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) — began on Thursday at the Sola Civil Hospital in Ahmedabad, the only site of its trial in Gujarat.
Five volunteers enrolled for the trial were administered the vaccine, according to Dr Parul Bhatt, head of medicine, at the Gujarat Medical Education and Research Society (GMERS)-run Sola Civil Hospital. She said if any adverse impact is seen during the trial, the hospital would treat the volunteer.
Dr Bhatt, who is the principal investigator, said, “Ten volunteers approached us today, of whom five were enrolled today (Thursday) and administered the vaccine.”
A total of 1,000 volunteers are being targeted and 500 vaccines in a storage temperature between 2-8 degree Celsius arrived in Gujarat on November 24.
While the study design as registered in the clinical trials registry indicates that volunteers can be aged between 18 and 99 years, Bhatt added that right now volunteers between 18 and 60 years of age only will be included.
She added that anyone infected with Covid-19 or a family member in the same household who contracted the infection cannot be considered as a volunteer. If a volunteer contracts Covid-19 in between doses, they shall require to be excluded from the trial.
While participants with comorbidities such as hypertension, diabetes, ischemic heart disease can be included, subject to the fact that they have reported stable vitals in the past three months, those with autoimmune diseases cannot be considered, Bhatt told The Indian Express.
“The intramuscular two-dose vaccine will include observation of the volunteer for 30 minutes after first dose, on site, followed by a follow-up in the next 24 hours. A second follow-up will be on day 15 (day 0 is when the first dose is administered), followed by a second dose on day 28,” Bhatt said.
Gujarat-based Zydus Cadila vaccine candidate is nearing completion of its second phase, with dosing stage completed, and follow-up and data analysis remaining.
It is a three-dose vaccine, with Phase-2 trials conducted in at least nine sites, including in Uttar Pradesh and Maharashtra, apart from in Gujarat hospitals. The Phase-1 trial was conducted at the single site of Zydus Research Centre, as per an official.
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