The government has identified five sites across the country for the third and final phase of the human trials of the Oxford-AstraZeneca Covid-19 vaccine, PTI reported on Monday. The Serum Institute of India, which is the world’s largest vaccine maker in terms of the number of doses produced and sold globally, has partnered with biopharmaceutical company AstraZeneca to mass produce the Oxford vaccine.
“The DBT [Department of Biotechnology] is now setting up Phase 3 clinical sites,” Secretary of Department of Biotechnology Renu Swarup told PTI over phone. “We have already started working on them and five sites are now ready to be available for Phase 3 trials.” Swarup added that the sites will be ready within a few weeks for “manufacturers to take them up for clinical trial 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, reported The Indian Express. Swarup said that companies will have a large database of volunteers once the trial sites are ready. “Having trained and equipped sites for field trials in healthy populations has been a challenge for vaccine manufacturers,” said the DBT secretary. “These five sites will meet this challenge.”
Swarup added that it was an essential step because it is necessary to have data within the country before the vaccine is administered. The Serum Institute expects to vaccinate everyone in India in two years.
Last week, the Serum Institute of India had said that it will apply for a licence to start clinical trials of the coronavirus vaccine developed at Oxford University. “We are confident on going on to the Phase 3 trials in India in August and we forecast that it will take probably two to two-and-half months to complete,” Adar Poonawalla, chief executive officer of Serum Institute of India, had said. “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”
The vaccine, called AZD1222, produced an immune response and was safe in early-stage clinical trials, according to trial results published in The Lancet medical journal. The Oxford vaccine prompted an antibody response within 28 days and a T-cell response within 14 days. Neutralising antibodies, which can disable the virus, were detected in most participants after one shot, and in all of them after two.
The trial sites will be used by other vaccine candidates as well, reported The Indian Express. Apart from the Oxford vaccine, two indigenous vaccines – one by Zydus Cadila and the other by Bharat Biotech – have reached phase one of human trials in India.