COVID-19 vaccine: 80% volunteers refuse Phase-III trials for Covaxin

Virendra Pandit

New Delhi: Even as the world is anxiously waiting for large-scale vaccination against the COVID-19 pandemic, the Phase-III trials for an Indian vaccine candidate—Covaxin—have run into rough weather as 70-80 percent of volunteers have refused to undertake this last-mile exercise.

These trials were expected to be completed by the end of December 2020 for the launch of the vaccine next month.

According to Dr. Sanjay Rai, Professor of Community Medicine at the All India Institute of Medical Sciences (AIIMS), who is also a principal investigator for the Covaxin trial, motivation to participate in trials may have been lost as people feel that a vaccine has already been found, media reported on Friday.

Due to this development, the rollout of the vaccine by Bharat Biotech for the general public may get delayed as the AIIMS, where its Phase-III human clinical trial is underway, is struggling to find takers of the trial shots, he said.

Prime Minister Narendra Modi had visited the Hyderabad-based Bharat Biotech International Ltd, which is making Covaxin, along with two other vaccine-developing facilities in Ahmedabad and Pune, recently.

Surprisingly, while Phase-I and II trials had zero refusal rates and went on smoothly, the Phase-III trials for Bharat Biotech’s COVID-19 vaccine candidate Covaxin are facing a shortage of volunteers with a participant refusal rate of up to 70-80 percent, Dr. Rai said.

Phase-I had 4,500 applicants for 100 volunteer spots, and Phase-II had 4,000 volunteers for 50 spots. However, for Phase-III which requires 1,500-2,000 participants, only 200 volunteers turned up.

“This is happening because people are thinking ‘why to volunteer when a vaccine is coming for everyone soon?’ he said, adding that excitement has shifted from clinical trials towards the vaccine.

“As per the central government’s guidelines, vaccines will only be administered to priority groups in the first phase. Fact is that, even if a vaccine comes, it’ll be given to healthcare providers, frontline workers, the elderly, and those with co-morbidities first. But people think they will get vaccine soon,” he pointed out.

Another reason for refusal, Dr. Rai said, was that participants were reluctant because half of them would be administered placebo and won’t know whether they are part of the vaccine group or placebo group.

“Most participants refuse after listening to this saying that a vaccine is coming soon. We are now planning to create awareness among people through ads, email, and telephone. It’s important for people to participate in the clinical trial to get a safe and efficient vaccine,” he stated.