Serum Institute to resume Phase 2/3 clinical trials of AstraZeneca-Oxford COVID-19 Vaccine
Drugs Controller General of India (DCGI) Dr. VG Somani on Tuesday allowed the Serum Institute of India to resume clinical trials of the Oxford COVID-19 vaccine in India after a short pause due to an 'unexplained illness' reported among the candidates in UK trials.
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"You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (DSMB), India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up," the letter said as reported by ANI.
The recruitment of the candidates for the clinical trials was suspended in India by the DCGI after The AstraZeneca had paused clinical trials in other countries. However, the clinical trials have now resumed by the pharma giant AstraZeneca in the UK.
The Serum Institute has already submitted a summary of safety follow up of seven days post first vaccination to the DCGI with claims that there are no serious adverse events that were experienced by any of the subjects till the date of reporting.
Pune based firm has partnered up with the pharma giant AstraZeneca was granted permission by India's top drugs' regulator in August to conduct a phase 2/3 clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine.