Amidst race for vaccine, govt readies trial sites, detailed data on volunteers
The government has at least five sites ready across four states for late-stage human clinical trials expected by the end of this year for several Covid-19 vaccine candidates, including those developed by the University of Oxford, Zydus Cadila and Bharat Biotech. An additional six sites are being set up to ensure ready availability of healthy participants.
Speaking to The Indian Express, Department of Biotechnology Secretary Dr Renu Swarup said that with trial sites ready, companies would have a handy and large database of volunteers, “a couple of thousands” at each site, as well as trained personnel, at a time when efforts are being fast-tracked to find a vaccine against rising cases.
Locating the right volunteers — who have not been infected with Covid-19 earlier, are not asymptomatic and are healthy — has been a problem in conducting clinical trials.
Swarup said the five sites had been established by the National Biopharma Mission and Grand Challenges India Programme — a partnership between the government and the Bill and Melinda Gates Foundation to encourage innovative health and development research. A common protocol has been established to initiate Covid epidemiology studies.
The five sites are at INCLEN Trust International in Palwal, Haryana; KEM in Pune; the Society for Health Allied Research in Hyderabad; the National Institute of Epidemiology in Chennai; and Christian Medical College in Vellore, Tamil Nadu.
“Having trained and equipped sites for field trials in healthy populations has been a challenge for vaccine manufacturers. These five sites will meet this challenge,” Swarup said, adding that the five, as well as additional ones (including the existing Demographic Surveillance Sites that are being upgraded), would meet global regulatory requirements and would be available to any group conducting phase-III human trials. She called this among the government’s “top-most” priorities at this time.
While the Oxford vaccine seems the most likely for phase-III stage now, Swarup added that, “irrespective of the candidate, our aim remains to strengthen manufacturing capacities so as to have equitable distribution of the vaccine to all citizens”.
Outlining how the sites would shorten timelines for vaccine developers, the DBT Secretary said, “There are a lot of ethical guidelines that need to be followed. So if you keep all that ready, you get (the volunteer’s) consent, then the trials can start immediately.” Also in place would be engagement with the community as well as information on comorbidities regarding the volunteers, data on sero surveillance, and access to the Central Immunoassay Laboratory.
“We are confident this will be a world-class clinical trial network,” Swarup said, adding that scientists will be able to follow up on the volunteers over a long duration.
Welcoming the initiative, a clinical trial practitioner involved in the development of a Covid-19 vaccine said, “Depending on the phase of the trial, the volunteers range from those without any comorbidities to those with comorbidities, but none of them should have had the infection earlier… We may screen several people but experience a high failure rate.”
One of the top contenders for a vaccine is Oxford University’s, which has shown encouraging results in early-stage trials. The Serum Institute of India (SII), that has a tie-up to manufacture at least a billion doses of this vaccine for low- and middle-income countries, is seeking permission for trials in India.
SII CEO Adar Poonawalla told The Indian Express earlier that the firm intended to conduct phase III trials on around 5,000 participants next month in cities like Mumbai and Pune, which have a high number of cases.
Several other firms in the country are working on Covid-19 vaccines. Of these, Bharat Biotech and Zydus Cadila are currently conducting phase I/II trials. Other firms like Gennova Biopharmaceuticals intend to begin phase I trials by October.