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Thursday, February 15, 2024

India: firm gets approval for COVID-19 vaccine human trails

British-Swed firm with University of Oxford gets approval to execute human trials for COVID19 vaccine in India.

The drug controller body of India granted permission to a local firm for conducting clinical human trials of COVID-19 vaccine developed by Oxford University, an authority announced on Monday.

The Drug Controller General of India approved the apply of Serum Institute of India for the phase two and three trials of the vaccine, known as ChAdOx1 nCoV-19 or AZD1222, in India as the “trials have shown promising results.”

India will be the site for human trials of vaccine 

“Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-AstraZeneca #COVID19 vaccine (COVISHIELD) in India,” the Health Ministry said on Twitter.

Read more: Moderna says COVID-19 vaccine in final phase of human trials

Adar Poonawalla, CEO of the firm, had said that as they were given permission, the trials for the vaccine in India would begin.

He said his company was one of nine companies across the globe which has collaborated with the UK-based AstraZeneca biopharmaceutical company, a co-developer of the Oxford vaccine.

University of Oxford and firm AstraZeneca behind creation of vaccine

The COVID-19 vaccine candidate has been developed by the Unversity of Oxford and British-Swedish firm AstraZeneca. At present, phase II and II clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase II clinical trial in Brazil and phase I and II clinical trials in South Africa. AstraZeneca has partnered with SII to develop COVID-19 vaccine for India and low-to-middle income countries.

Read more: Vaccine trials ‘produce immune response’, give hope against COVID-19

The company submitted this MoU in the revised proposal.

“The dropout rate of 41 percent should be revised to keep the rate at par with other vaccine studies,” said the minutes.

“Immunogenicity shall be either primary or secondary objective,” the minutes said. Immunogenicity means the ability of a foreign substance to provoke the body and create an immune response.

It also asked for “interim analysis of immunogenicity cohort to be carried out only after day 58 both for safety and immunogenicity.”

The panel had recommended that the human trial sites for the study should be distributed across the country. Around 1,600 people will participate in the clinical trial. Volunteers must be above 18 years old to take part in the study. Serum Institute has selected 17 institutions to conduct the advanced trials. The firm is then set to execute human trials for the vaccine within Inida.

These sites are 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.

Monday’s development came at a time when the coronavirus infections crossed 1.8 million in India, with the country reporting over 50,000 new cases in the last 24 hours.

Various sources with additional analyses from GVS New Desk