India readies 5 sites for final phase of human trials of Oxford covid-19 vaccine; Serum to start manufacturing next month
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India readies 5 sites for final phase of human trials of Oxford covid-19 vaccine; Serum to start manufacturing next month


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The Department of Biotechnology informed that 5 sites are ready to start phase 3 and final human trials of the Covid-19 vaccine.

In a recent development regarding the Oxford Vaccine phase 3 trials, Renu Swarup,  Secretary of Department of Biotechnology (DBT) confirmed that Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca COVID-19 vaccine.

In a telephonic interview to PTI, Swarup said, “This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians.”

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 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.”

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.

A few days ago, the Pune-based SII has also sought permission from the Drugs Controller General of India (DCGI) for conducting Phase 2 and 3 of human clinical trials 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.

Vaccine Manufacturing

The Serum Institute of Technology 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.

The Pune-based vaccine maker plans to manufacture two-three million doses of vaccine by end-August. 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. T cells are white blood cells that can attack cells infected with the SARS-CoV-2 virus that causes COVID-19 disease.

Pricing:

About the pricing of Oxford’s COVID-19 vaccine in India, Adar Poonawalla said, “It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose.”

He further added it is extremely likely that the COVID-19 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.


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