coronavirus update indiaas on : 28 October 2020 04:51 GMT+5:30
India Readies 5 Sites To Begin Phase 3 Human Trail Of Oxford COVID Vaccine
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
India Readies 5 Sites To Begin Phase 3 Human Trial Of Oxford COVID Vaccine
New Delhi: In the recent development regarding the Oxford Vaccine phase 3 trial, Secretary of Department of Biotechnology Renu Swarup confirmed that Five sites across the country are ready for the third and the final phase of human trails of the Oxford-AstraZeneca COVID-19 vaccines.
Renu Swarup in a telephonic interview with PTI said that "This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians."
According to Reny, the DBT is the part of any coronavirus 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 that 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."
Oxford and its partner AstraZeneca has chosen The Serum Insitute of India, the largest vaccine maker in the world to manufacture the vaccine once it is ready. Earlier this month trails result for the first two phases were published.
The Pune based SII has sought permission from the Drug Controller General of India(DCGI) a few days ago for conducting Phase 2 and 3 for the human clinical trial of the potential vaccine.
"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.
Earlier the Serum Institue of Technology had said that it will start manufacturing the vaccine even before the final nod so it is ready with sizable volumes once the get all permission.
By the end of August, the Pune based vaccine maker plans to manufacture two-three million doses of vaccine. Earlier this week, preliminary results of the phase1/2 trial published in the medical journal The Lancet show Oxford COVID-19 vaccine ChAdOx1 nCoV-19 induces strong immune responses with no early safety concerns.
The researchers reported that the vaccine triggered a T-cell response within 14 days of vaccination and an antibody response within 28 days.
Adar Poonawalla about the pricing of Oxford's COVID-19 vaccine in India,"It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose."
Further, he added it is extremely likely that the coronavirus vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
"I don’t think any citizen of India or of any other country is going to have to pay for it because it is going to be bought by the government and distributed free," Poonawalla said. They expect the vaccine to reach the people of India in large numbers by the first quarter of 2021, he added.
(Inputs from PTI)