The Drugs Controller General of India (DGCI) has given approval to the Serum Institute of India, Pune, to conduct Phase II and III clinical trials of Oxford University-Astrazeneca COVID-19 vaccine in India, the Health Ministry said on Monday, 3 August.
The SII received approval by India's top drug regulator on Sunday, after an evaluation based on the recommendations of the Subject Expert Committee on COVID-19, reported IANS.
The institute had submitted an application seeking permission for conducting the trials in the last week of July, the report added.
According to a PTI report, 1,600 people will participate in the trials, aged 18 years and above. Candidates for the ‘Covidshield’ vaccine will be selected from 17 different sites including AIIMS-Delhi, BJ 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.
Earlier, on 27 July, Secretary of the Department of Biotechnology (DBT) Renu Swarup said that five sites across the country had been identified for the third and final phase of human trials of the Oxford-Astrazeneca COVID-19 vaccine.
On 20 July, scientists announced that the coronavirus vaccine developed by Oxford University has shown good immune response and may be safe for human use.
“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, CEO, Serum Institute of India
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.
As per an IANS report, the vaccine is in its Phase II and III clinical trials in the UK, Phase III trials in Brazil, and Phase I and II clinical trials in South Africa.
Preliminary Data from Phase 1/2 Trials of Oxford Vaccine
FIT had reported earlier that the University of Oxford's coronavirus vaccine was found to be safe with capabilities of triggering an immune response.
The results of Phase 1 of the human trials involving 1,077 people was recently published where the vaccine was observed to be boosting T cells and antibody immunity.
The study also found that the T cell immunity peaked after two weeks and dropped slightly by day 56. Antibody immunity, however, peaked after four weeks and remained high by day 56, indicating that it may well last for even longer.
As per the study, 90 percent of the test subjects developed neutralising antibodies just after one dose. Ten people required a double dosage for the antibodies to kick in.
Despite the excitement, trial results will have to be examined on a larger scale for the vaccine to be certified as safe for all.
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