Lack of volunteers slows down phase-3 Covaxin trials at Bengaluru hospital
A less than enthusiastic participation by volunteers has slowed down phase-3 clinical trials of the country’s indigenous COVID-19 vaccine (Covaxin) at Vydehi Institute of Medical Sciences and Research Centre in Bengaluru. This is even as Hyderabad-based Bharat Biotech, which is developing Covaxin, applied to the Drug Controller General of India (DGCI) again for emergency use authorisation on December 23.
When the trials started on December 2, the hospital had aimed to administer the first dose of vaccine to 1,000 volunteers in a week. However, as of December 26, only 480 people had received the dose.
While there has been a lack of enthusiasm in the general public, the State’s elected representatives and IAS/IPS officials, apart from celebrities, have voluntarily participated in the trials and taken the first dose. Over 65 volunteers are senior citizens too. The hospital has roped in Clintrac International Ltd., an autonomous research institute for the trials.
Chaitanya Adikeshavlu, one of the directors of Clintrac, told The Hindu on Saturday that about 120 of the 480 volunteers are politicians, IAS, IPS officials, and some other celebrities. “There is some hesitation among people to participate in the trial as they may be worried about side effects. But, the vaccine is completely safe. Several doctors from Vydehi, including me and my family, have taken the dose and none of us have had any problem,” she said.
“The plan is to roll out the vaccine by the second week of January for the priority group of healthcare workers. And for this, we have to complete the phase-3 trials by the year-end. We need 520 more volunteers and appeal to people to come forward and participate in the trials,” she said. The hospital has now offered travel arrangements for volunteer groups from residents’ welfare associations and apartments who want to be part of the trial.
Covaxin clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose. It is the largest phase-3 clinical trial conducted in India. It is also the only efficacy trial being conducted in India for COVID-19 vaccine, to determine its suitability for the diverse Indian population.
D.V. Chalapathy, co-investigator of the trials, said anyone aged above 18 can participate. “As the vaccine candidate is preventive and curative, it will be given to those who test negative and are asymptomatic. Anyone who wants to volunteer can walk into our institute and enroll. Interested people can also call 97394 19272 and ask to be connected to the Covaxin clinical trial room,” he said.
C N. Manjunath, nodal officer for labs and testing in the State’s COVID-19 task force, attributed the vaccine hesitancy to fear factor. No major side effects have been observed so far, he said.
“People are worried about adverse effects. It is likely that vaccination will be associated with mild adverse events such as soreness at the injection site, fever, fatigue, and myalgias. These are universal side effects with any vaccination. Efforts should be made to propagate the message that vaccination is safe in society. Awareness drives should be conducted to boost the confidence of people,” he said.
V. Ravi, former professor and head of the department of Neurovirology at NIMHANS, who is part of the State’s Technical Advisory Committee (TAC), said champion advocacy is the need of the hour. “More celebrities and eminent personalities should participate in the trials and publicise their participation. Vaccine reluctance is natural in the beginning but this can be turned into acceptance with more awareness,” he said.
Shashi Bhushan B.L., professor and head of the department of Pulmonary Medicine at Victoria Hospital, Bangalore Medical College and Research Institute, said no vaccine would be 100% effective. “A vaccine that protects against developing clinical illness may not prevent transmission to others. Also, the duration of naturally occurring immunity to infection with severe SARS-CoV-2 is unknown and may wane with time. More awareness should be created to clear all doubts in the minds of people,” he added.