AIIMS Could Not Find Volunteers Required for Phase 3 Trial of Bharat Biotech’s COVID Vaccine

The AIIMS is unable to find the required number of volunteers for Bharat Biotech’s Phase 3 COVID-19 vaccine trial, with officials saying people are unwilling to participate in the exercise thinking why to take part in a experimentation when a vaccine would soon be available to everyone.

The All India Institute of Medical Sciences (AIIMS) in the national capital is one of the sites conducting the final phase of the Covaxin vaccine trial and needs approximately 1,500 volunteers for the purpose.

Covaxin was developed in-house by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).

“We wanted 1,500-2,000 participants, but so far we have only been able to recruit about 200 participants. People are unwilling to participate in the exercise thinking about why taking part in a trial when a vaccine would soon be available to everyone,” Dr. SanjayRai, a professor in the department of community medicine at AIIMS and also the principal investigator of the study, said.

He said volunteers are choosing not to participate when explained to them about the procedure, that this is a double-blind, randomized, placebo-controlled trial in which 50% would be given while the other 50% would receive placebo.

“People refuse to participate in the clinical trial after learning about the procedure, saying why take part in a trial when a vaccine is soon available,” said Dr. Rai.

He said when the Phase 1 trial was due to begin, they needed 100 participants but received over 4,500 questions.

Even during Phase 2 of the trial, the hospital received around 4,000 applications.

Dr. Rai said people should come forward to participate in the trial and are planning to raise awareness through advertisements, emails and phone calls as to why it is important to take part in the clinical trial to get a safe and effective vaccine.

According to the “COVID-19 Vaccine Operational Guidelines”, which were recently issued in states by the Center, the COVID-19 vaccine will be offered first to healthcare professionals, frontline workers and those over 50, followed by those under 50 years of age with associated comorbidities, based on the evolution of the pandemic situation and, finally, on the remaining population, based on the epidemiology of the disease and the availability of vaccines.

The priority group over the age of 50 can be further divided into those over the age of 60 and those between the ages of 50 and 60 for phasing in, based on the pandemic situation and the availability of vaccines.

“The latest electoral roll for the Lok Sabha and Legislative Assembly elections will be used to identify the population aged 50 or over,” the guidelines state.

In the first phase of vaccination, nearly 30 million people are expected to be vaccinated.

Twelve photo identification documents including voter ID, Aadhaar card, driver’s license, passport and retirement documents will be required for self-registration on the Co-WIN website.

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