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 on Monday.
This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians, Swarup told PTI.
The Serum Institute of India, the largest vaccine maker in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier this month.
According to Swaroop, the DBT is part of any Covid-19 vaccine effort in India “… whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks which exist within the country”.
“The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials,” Swarup told PTI in a telephonic interview.
The Pune-based SII has also sought permission from the Drugs Controller General of India (DCGI) for conducting Phase 2 and 3 human clinical trials of the potential vaccine.
It had said earlier it will start manufacturing the vaccine even before the final nod so it is ready with sizable volumes once the vaccine gets all permissions.
“DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important because if the vaccine has to be successful and it has to be given to the Indian population we need to have the data within the country.
“For that a Phase 3 trial has been proposed. Five sites are ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies,” the DBT secretary said.
On July 20, scientists announced that the coronavirus vaccine developed by Oxford University 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 crore people across the world and claimed more than six lakh lives.
Doses of the vaccine were given to 1,077 healthy adults aged between 18 and 55 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 they induced strong antibody and T-cell immune responses for up to 56 days after they were given. T-cells are crucial for maintaining protection against the virus for years. The findings are seen as promising, but experts feel it is too soon to know if this is enough to offer protection as larger trials get underway.
Scientists behind the trials found the response could be even greater after a second dose.
In Phase 1 of human trials, a vaccine is given to a small number of people to test safety. It is also given to check if it stimulates the immune system.
In the second phase, it is administered to hundreds of people split into groups such as children and the elderly to see if the vaccine acts differently in 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 by Zydus Cadila and the other by Bharat Biotech – have reached the stage of phase one of human trials.