Covaxin: Bharat Biotech's COVID-19 vaccine trial will enroll 2,000 volunteers each in metros

New Delhi, Nov 21: Bharat Biotech International Ltd plans to enrol about 2,000 participants each in metros - Delhi, Mumbai, Hyderabad and Kolkata for phase 3 trials of its coronavirus vaccine Covaxin that began earlier this week, the company said.

In a statement given to Mint the company said, "Interested volunteers staying in the same city or near the clinical trial study site can meet/contact the principal investigator or co-investigator for participating in the clinical trial. The principal investigator will recruit the participant based on the protocol defined eligibility criteria."

According to the statement of the company, participation in the trial is voluntary and based on informed consent, participants will not be paid anything, other than travel fare.
In the case of any side-effect, the medical cost will be reimbursed.

However, people below 18 years or those who tested positive for covid-19 earlier will not be eligible for the clinical trial.

After being screened for eligibility, trial participants will receive two intramuscular injections about 28 days apart.

Participants will be randomly assigned equally to receive either two 6-microgram injections of Covaxin or two shots of a placebo.

The trial is double-blinded, meaning the investigators, the participants and the company will not be aware of who is assigned to which group until the end of the trial.

Untill the trial ends, the participants will not be allowed to take another company's vaccine. But if the efficacy data of Bharat Biotech is not strong enough to get authorization at the completion of the study, or the trial stops early based on interim results, the participant can take another vaccine as per the government's standard care protocol, the company said.