Serum Institute Gets Nod for Phase 2,3 Trials of Oxford Vaccine

The DCGI has given approval to Serum Institute of India to conduct Phase 2 and 3 clinical trials of Oxford vaccine.

Updated
The DCGI has given approval to Serum Institute of India to conduct Phase 2 and 3 clinical trials of the Oxford vaccine candidate in the country.
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The Drugs Controller General of India (DCGI) has given approval to Serum Institute of India (SII), Pune to conduct Phase 2 and 3 human clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine in India.

The SII received permission after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.

According to a PTI report, 1,600 people aged above 18 years will participate in the trials for ‘Covidshield’ vaccine candidate across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

SII CEO Adar Poonawalla, CEO, Serum Institute of India had sought approval from the Indian regulator to carry out human trials in India. He had said,

“The trials have shown promising results and we are extremely happy about it. We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes.”
Adar Poonawalla

The vaccine candidate is in the midst of Phase II and III clinical trials in the UK, Phase III trials in Brazil, and Phase I and II clinical trials in South Africa, IANS reported.

Preliminary Data from Phase 1/2 Trials of Oxford Vaccine

The University of Oxford's coronavirus vaccine was found to be safe and capable of triggering an immune response, as FIT had earlier reported. The long-awaited Phase 1 human trial involving 1,077 people results were published on 20 July inThe Lancet. The vaccine boosted T cell and antibody immunity and produced strong responses on both accounts, the study found, with T cell immunity peaking after two weeks and then dropping slightly by day 56. Antibody immunity, on the other hand, peaked after four weeks and remained high by day 56, indicating that it may well last for even longer.

The study showed 90% of people developed neutralising antibodies after one dose. Ten people required two doses to produce neutralising antibodies.

While exciting, larger trial results will have to be examined before we can say the vaccine is safe and provides protection.

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