Phase 3 trials for Bharat Biotech’s Covaxin see 70-80 percent refusal rate from volunteers.

Bharat Biotech vaccine Covaxin Phase 3 trial is moving slowly as a lesser number of participants are willing to be a part of the trial process.

Bharat Biotech vaccine Covaxin Phase 3 trial is moving slowly as a lesser number of participants are willing to be a part of the trial process.The vast majority of people are still vulnerable to COVID-19 and several vaccines are in the process to testing. Vaccines typically require years of research and testing before reaching the clinic, but scientists are running to produce a safe and effective coronavirus vaccine as soon as possible.

In collaboration with the Indian Council of Medical Research (ICMR), Bharat Biotech developed COVID-19 vaccine candidate 'COVAXIN,' which had received DCGI approval for the first and second phase of human clinical trials, which commenced across India starting July 2020. On Nov. 16, 2020, Bharat Biotech announced the commencement of Phase 3 trials of COVAXIN, which would involve 26,000 volunteers across India, conducted in partnership with ICMR.

In an interview with NDTV, Dr. Sanjay Rai, Principal Investigator of Phase-3 COVAXIN trial at All India Institute of Medical Sciences (AIIMS), said that the third phase of the vaccine trial was facing a shortage of volunteer participation, with a high refusal rate of 70 to 80 percent. When the clinical trial for Phase-1 began, they required only 100 volunteers and received over 4500 applications. But in the trial's third phase when AIIMS needed 1,500-2,000 participants, only 200 had enrolled.

Further, Dr. Rai said they had planned to create awareness among people through ads, email, and the telephone because people need to participate in the clinical trials to get a safe and efficient vaccine. The authorities are hoping to finish Phase 3 of the clinical trial by the end of this year.

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