Serum Institute of India has resumed the Phase 2 “Covishield” study, investigating the safety and immunogenicity of the Oxford vaccine candidate, now overseen by AstraZeneca. Although the same vaccine candidate is now in an indefinite holding pattern in the United States by the U.S. Food and Drug Administration (FDA), the Indian drug development sector moves full throttle forward in the Southern Indian state of Tamil Nadu. The state’s largest city, Chennai, hosts two of the 17 trial sites across India, the world’s second most populated nation and seventh largest economy as measured by GDP, and well-positioned to soon pass France to the number six position.
Tamil Nadu has nearly 70 million people with Chennai totaling about 7.1 million. Tamil Nadu has reported 586,000 cases of COVID-19 with 9,383 deaths. The Serum Institute of India (SII) is the busiest vaccine producer in the world and inked a deal with AstraZeneca to co-develop the Oxford vaccine called AZD1222 by AstraZeneca and Covishield by SII in India.
Volunteers received shots starting this week as the clinical trial resumed in this country. Again, TrialSite learned that the same vaccine product is on indefinite hold by the U.S. FDA to investigate at least two neurological issues reported with volunteers in the UK. The UK study has resumed as well.
Officially titled “A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenecity of Covishield (COVID-19 vaccine) in Healthy Indian Adults,” The Clinical Trials Registry of India reveals that the study will include 1,600 volunteers, 18 or older in age, across the 17 sites established and listed in the registry. 400 participants will be included in the immunogenicity cohort, reports the Times of India. The remaining 1,200 are part of the safety cohort.
Tamil Nadu Trial Sites
The trial sites selected by SII in Tamil Nadu include Rajiv Gandhi Government General Hospital and Sri Ramachandra Institute of Higher Education and Research in Porur.
The Rajiv Gandhi Government General Hospital actually dates back to 1664 by the British East India Company and represents India’s first medical institution. By the 19th century, it merged with the Madras Medical College. With about 2,772 beds, the hospital cares for 12,000 outpatients per day.
Sri Ramchandra Institute of Higher Education and Research was established in 1985 as part of the Sri Ramchandra Educational & Health Trust. Based in Chennai, the private institute consists of nine constituent colleges and faculties with over 6,000 students.
Principal Investigator Point of View
Dr. T S Selvavinayagam leads the study, serving as director of public health and principal investigator for the study. Affiliated with Emory University in the U.S., Dr. Selvavinayagam heads the Tamil Nadu research effort for the vaccine and reported to the local press, “This phase requires 110 to 150 volunteers. Screening of volunteers to see if they are fit enough for the trial is going on.”
TrialSite reminds that the Indian authorities have agreed to let the AstraZeneca-sponsored clinical trial resume, however under the condition of additional monitoring and safety surveillance.
Overseeing the entire study is Dr. Prasad Kulkarni, Medical Director of the Serum Institute of India.