While the nation hopes the wait for a Covid-19 vaccine will end soon, the process may take longer than expected. Vaccine trials face setbacks in India as the number of people taking part in trials is declining.
Bharat Biotech’s Covaxin vaccine is currently in phase 3 of the nationwide human clinical trial stage. While vaccine manufacturers have applied for an emergency use authorization from the Indian pharmaceutical authorities, the trial is progressing slowly as fewer participants are willing to be part of the trial process.
“When a healthy volunteer signs up with us, as is ethical, we have to tell them that we won’t know if they have been given a vaccine or a placebo. People now hesitate to take a placebo. They say why we should volunteer to have a 50% chance of getting a vaccine. They believe that the Covid-19 vaccine will soon be available in India, in a matter of weeks, ”said Dr. Sanjay Rai, principal investigator of the trials and professor of community medicine at AIIMS, New Delhi.
“Therefore, the rejection rate of the participants has increased. For phase 3, the rejection rate is approximately 70 to 80 percent. By comparison, the rejection rate during phase 1 was less than 10 percent, even when not much was known about the safety or efficacy of Covid-19 vaccines in the world, “he said.
Dr. Rai said that phase 1 had 4,500 applicants for 100 volunteer positions; Phase 2 had 4,000 volunteers for 50 places. In phase 3, 2,500 volunteers are required. However, only about 200-300 people have come forward to participate in the trial.
Currently, Bharat Biotech is conducting clinical trials with more than 22,000 volunteers at 18 sites across the country.
The clinical center authorities have planned to raise awareness among people through announcements, emails and cold calls. There is a possibility that other trials of the Covid-19 vaccine at different stages will also face similar problems.
Recently, the Covid-19 vaccine being developed by Pune-based Gennova Biopharma received approval for phase 1 trials in the country. Hyderabad-based Biological E limited’s candidate vaccine is in phase 1/2 testing stages. Phase 2/3 human trials of the Sputnik V vaccine are also ongoing in India.
In the meantime, the Center has prepared a detailed guide for mass Covid-19 vaccination. The Union’s health ministry has also directed states to prepare for adverse events after Covid-19 vaccination.
