Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca Covid-19 vaccine, Department of Biotechnology (DBT) Secretary Renu Swarup said Monday.
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This is an essential step because it is necessary to have data within the country before the vaccine is administered to the Indians, Swarup told PTI.
Oxford and its partner AstraZeneca have chosen the Serum Institute of India, the world’s largest vaccine manufacturer, to manufacture the vaccine once it is ready. The results of the trials for the first two phases were published earlier this month.
According to Swaroop, DBT is part of any Covid-19 vaccine effort in India “… whether it is funding, whether it is facilitating regulatory authorizations or giving them access to different networks that exist within the country.”
“DBT is now establishing Phase 3 clinical sites. We have already started work on them and now five sites are ready to be made available for Phase 3 trials,” Swarup told PTI in a telephone interview.
The Pune-based IBS also requested permission from the Indian General Drug Controller (DCGI) to conduct Phase 2 and 3 human clinical trials of the potential vaccine.
He had said before that he will start manufacturing the vaccine even before the final assent so that it will be ready in considerable volumes once the vaccine is fully licensed.
“DBT is working closely with all manufacturers and the Phase 3 serum test (institute) is important because if the vaccine is to be successful and should be administered to the Indian population, we need to have the data within the country.”
“A Phase 3 trial has been proposed for that. Five sites are ready. In a few more weeks, they should be ready for manufacturers to take them to clinical trial studies,” said the DBT secretary.
On July 20, scientists announced that the coronavirus vaccine developed by the University of Oxford appears safe and induces a strong immune response within the body after the first phase of “promising” human trials against the deadly disease that has infected over 1.45 million people worldwide and claimed more than six lakh lives.
The vaccine doses were administered to 1,077 healthy adults aged 18-55 years in five UK hospitals in April and May as part of the Phase 1 clinical trial and results, published in The Lancet medical journal. The results show that they induced strong immune responses of antibodies and T cells for up to 56 days after they were administered.
T cells are crucial to maintaining protection against the virus for years. The findings are considered promising, but experts believe it is too early to know if this is enough to offer protection as larger trials are conducted. The scientists behind the trials found that the response could be even greater after a second dose.
In Phase 1 of the human trials, a vaccine is administered to a small number of people to assess safety. It is also administered to check whether it stimulates the immune system.
In the second phase, it is administered to hundreds of people divided into groups such as children and the elderly to see if the vaccine works differently for them. The two phases focus on safety and immunogenicity in humans.
In the third phase, the vaccine is administered to thousands of people. In India, two indigenous vaccines, one from Zydus Cadila and the other from Bharat Biotech, have reached the phase one stage of human trials.
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