By Priyanka Sharma ANI |
Updated: Dec 16 2020 21:00 IST
New Delhi [India], Dec 16 (ANI): With the start of Covid vaccination, an immediate future in India, the phase III clinical trial for Bharat Biotech’s locally developed COVAXIN vaccine candidate is witnessing a shortage of volunteer participation, with a high rejection rate of 70% to 80 percent, a senior AIIMS physician said Wednesday.
“When the clinical trial started, we wanted 100 volunteers and we received more than 4500 applications. In phase II, we wanted 50 and we received 4000 applications. In phase III, now that we wanted 1500-2000 participants, we could only recruit about 200 participants from It’s happening because people are thinking about why volunteer when a vaccine for everyone is coming soon, “Dr. Sanjay Rai, professor of community medicine at AIIMS, told ANI.
Dr Rai said there is not much enthusiasm for the clinical trial as people are overly excited about the vaccine, adding that according to central government guidelines, in the first phase, the vaccines will only be given to priority groups.
“The fact is, even if a vaccine does come, it will be given first to healthcare providers, frontline workers, the elderly with comorbidities. But people believe they will get it soon,” he added.
The government’s National Group of Experts on Vaccine Administration for COVID-19 (NEGVAC) recommended that prioritized population groups be specifically vaccinated.
The group includes: approximately one crore, healthcare workers (TS), healthcare providers, and healthcare workers; approximately two million frontline workers (PDAs), which includes personnel from the central and state police, armed forces, domestic guards, civil defense and disaster management volunteers, municipal workers; approximately 27 million rupees prioritized the population group over 50 years old and people under 50 years old with associated comorbidities.
“This scenario was not seen in the phase I and phase II clinical trials … There was no rejection rate,” said Dr. Rai, principal investigator of the COVAXIN clinical trial.
Dr. Rai opined that because phase III is a double-blind clinical trial, authorities should inform participants that 50% would receive the vaccine and the other 50% would receive the placebo.
“After hearing this, most of the participants refuse to take part in the clinical trial saying that the vaccine is coming soon. We are now planning to raise awareness among people through advertisements, email and phone. It is important that people participate. in the clinical trial to get a safe and effective vaccine, “he said.
The doctor added that authorities expect to finish the phase III clinical trial by the end of this month (December).
Meanwhile, the Center has prepared a detailed guide for mass vaccination of COVID. The Union Ministry of Health also directed states to prepare for adverse events following COVID-19 vaccination that cannot be ruled out.
Until such time as there is no vaccine, people should strictly follow appropriate COVID-19 behavior by wearing a mask, washing or sanitizing their hands, and maintaining social distancing. (AND ME)
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