BHOPAL: Gandhi Medical College (GMC), despite having category-II status with all required facilities, is still waiting for nod from ICMR-Bharat Biotech for conducting coronavirus vaccine phase-3 trials.
GMC, though short of volunteers for the vaccine trials, doesn’t want to miss the chance. The People’s College of Medical Sciences & Research Centre (PCMS), Bhopal, has already carried out vaccine trials. Currently, PCMS and GMC have been shortlisted for phase-3 trial in Madhya Pradesh. After phase-3, Bharat Biotech will go ahead with phase-4 trials.
Even if the gets the nod for phase-3 trials, the GMC is still short of the volunteers. There must be at least 100 volunteers for the trial, however, the GMC is far from the magic figure.
Doctors of GMC are positive that a minor incident during Phase-I trial of India's Bharat Biotech Covid-19 vaccine in August would not deter people from coming forward for the vaccine trial.
A 35-year-old volunteer with no comorbidities, who was part of Phase 1 trials in August, was hospitalised with viral pneumonitis after taking the vaccine.
Dr Simmi Dubey, in-charge of vaccine trial at Gandhi Medical College, said “We will not lose the chance of vaccine trial at out facility as we have made all required preparations for the ongoing phase-3 trial of Bharat Biotech-ICMR vaccine Covaxin. Now it rests with ICMR and Bharat Biotech as they are reviewing the phase-3 trial feedback.”
Besides, GMC does not want to increase the dropouts in second dose of shots and for the same we are not forcing any one for the trial, said Dubey, adding that motivated people themselves should come forward and volunteer for the trial.
A minor incident during the Phase I trial of Bharat Biotech Covid-19 vaccine in August has ‘demotivated’ the volunteers, said Dubey, adding that it was nothing major as a volunteer was hospitalized after taking a dose of the vaccine. Hoping that this would not deter the people from volunteering for the noble cause, the doctor hoped that people would definitely come forward. In case, we miss the phase-3 trial, ICMR-Bharat biotech may give us phase-4 trial, said the doctor.
Vaccine phase-3 trial in progress
For the Phase 2 trial, Bharat Biotech had recruited 400 volunteers, and for its phase 1 trial 375 participants were recruited across the country. Phase-1 trials were completed in August while phase-2 trial completed in October. Currently phase-3 trial are underway. Covaxin has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus that causes Covid-19.