New Delhi: Oxford vaccine for Covid-19 comes one step closer to human trials in the country as the subject expert committee, which advises regulator Drug Controller General of India (DCGI) on proposals seeking approvals for new drugs, vaccines or clinical trials has recommended to the top drug regulator to grant permission to Serum Institute of India (SII) to conduct phase two and three clinical trials in India on a potential COVID-19 vaccine.

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"After a thorough evaluation, the Subject Expert Committee (SEC) has sent its recommendation to DCGI asking it to give approval to Serum Institute's phase two and three human clinical trials of Oxford Vaccine candidate for COVID-19," a Health Ministry official told news agency ANI on Friday.

The protocol will now be moved to DCGI V.G. Somani, who is likely to take a “decision by the end of the week” given the urgency of the COVID challenge.

Earlier this week the committee observed certain observations and redirected Serum Institute to furnish a revised protocol to perform the clinical trials in India for the COVID-19 candidate vaccine. The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.

Observer Blind Trials

According to the revised protocol, the SII will conduct trials on 1600 people aged above 18 across 17 selected sites which includes AIIMS Delhi, BJ Medical College, Pune, RMRIMS Patna, AIIMS Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Vishakhapatnam, Graduate Institute of Medical Education and research in Chandigarh and JSS Academy of Higher Education and Research In Mysuru.

The pharmaceutical company will perform an observer-blind, randomized controlled study to determine the safety and immunogenicity of 'Covishield'.

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.