AIIMS unable to find required volunteers for Phase 3 trial of Bharat Biotech’s COVID vaccine, says officials

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

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

Covaxin has been indigenously developed 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 been able to recruit only around 200 participants. People are unwilling to participate in the exercise thinking why take part in a trial when a vaccine would be available soon for everyone,” Dr SanjayRai, professor in the department of community medicine at the AIIMS and also the principal investigator of the study, said.

He said volunteers are opting out when the procedure, about it being a double-blind randomised placebo-controlled trial in which 50 per cent would be administered the shot while the other 50 per cent would receive the placebo, is being explained to them.

“People are refusing to participate in the clinical trial after knowing about the procedure, saying why take part in a trial when a vaccine would be available soon,” Dr Rai said.

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

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

Dr Rai said people should come forward to participate in the trial and they are planning to raise awareness through advertisements, e-mails and phone calls on why it is important to take part in the clinical trial to get a safe and efficacious vaccine.

According to the “COVID-19 Vaccine Operational Guidelines”, which have been issued to the states by the Centre recently, the COVID-19 vaccine will be offered first to healthcare workers, frontline workers and those above 50 years of age, followed by those below 50 years of age with associated comorbidities, based on the evolving pandemic situation, and finally, to the remaining population, based on the disease epidemiology and vaccine availability.

The priority group of above 50 years may further be subdivided into those above 60 years of age and those between 50 and 60 years of age for phasing of the rollout, based on the pandemic situation and vaccine availability.

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

In the first phase of the vaccination, it is planned to vaccinate nearly 30 crore people.

Twelve photo-identity documents, including Voter ID card, Aadhaar card, driving licence, passport and pension documents will be required for self-registration on the Co-WIN website.