Serum Institute registers its Covid-19 vaccine trial

Confirming that the Covid-19 vaccine trial process has started, representatives of SII declined to reveal any more details on the development.

The Serum Institute of India (SII) has registered for Phase II/III clinical trials on the coronavirus disease (Covid-19) vaccine candidate, Covishield, being developed by Oxford University-Astra Zeneca, with the Clinical Trials Registry of India (CTRI). The trials will be conducted on 1,600 healthy participants across India.

Vaccine vials exit a vaccine vial monitor labelling machine at the Serum Institute of India Ltd. pharmaceutical plant in Pune, Maharashtra.(Bloomberg File Photo)

The All India Institute of Medical Sciences, New Delhi, is one of the 17 sites selected to conduct the trial-- a Phase II/III, observer-blind, randomized, controlled study, to check the safety and immune response of the Covid-19 vaccine candidate on healthy Indian adults.

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The study is planned for a duration of seven months, and the date of first enrolment will be August 24, as reported to the CTRI.

Serum Institute, the world’s largest vaccine manufacturer by number of doses produced and sold globally, has entered a manufacturing partnership with AstraZeneca to produce the vaccine, if and when it is approved for use.

On August 3, India’s drugs controller gave approval to SII for conducting Phase II and III clinical trials of the vaccine candidate in the country. The trials will be overseen by Dr Prasad Kulkarni as the principal investigator for SII.

Confirming that the trial process has started, representatives of SII declined to reveal any more details on the development.

The 17 hospitals that will be conducting these trials are Andhra Medical College, Visakhapatnam; JSS Academy of Higher Education and Research, Mysore; Seth G. S. Medical College and KEM Hospital, Mumbai; KEM Hospital Research Centre, Vadu; B J Medical College and Sassoon General Hospital, Pune; All India Institute Of Medical Sciences (AIIMS), Jodhpur; Rajendra Memorial Research Institute of Medical Sciences, Patna; Institute of Community Medicine,Chennai; Post-Graduate Institute of Medical Education & Research (PGIMER), Chandigarh; Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune; Jehangir Hospital, Pune; All India Institute of Medical Sciences, New Delhi, ICMR-Regional Medical Research Centre, Gorakhpur; Sri Ramchandra Institute of Higher Education and Research, Chennai; TN Medical College & BYL Nair Hospital, Mumbai; Mahatma Gandhi Institute of Medical Sciences, Sewagram; and Government Medical College, Nagpur.

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Barring one hospital- KEM Hospital Research Centre Ethics Committee, Pune, which has received the mandatory approval, ethics committee approval is still under process for the remaining 16 hospitals, shows a CTRI document.

Institute ethics committee clearance is a mandatory criterion to begin any clinical studies in India.

The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified.

“The Oxford University-Astra Zeneca vaccine candidate seems like the best bet at the moment but the stages at which all these vaccines candidates are currently, it could go either way. There is always a possibility that none of these might eventually work out but that doesn’t mean there should not be any planning for procurement or distribution,” says Dr K Srinath Reddy, founder, Public Health Foundation of India.

Healthy participants, both men and women, selected for the trial are above 18 years of age.

Those who are not eligible include people with acute illness with or without fever at the time of study vaccine administration, history of laboratory confirmed Covid-19 disease in household contacts or close workplace contacts, IgG seropositivity (antibodies) to Sars-Cov-2, history or currently positive for Sars-Cov-2 by real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR), history of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines, any confirmed or suspected condition with impaired/altered function of immune system, and pregnant women.