The Drugs Controller General of India (DCGI) has revoked the suspension of testing of the Oxford COVID-19 vaccine candidate, permitting it to resume its clinical trials in the country on Tuesday.
The DCGI allowed the vaccine trials to proceed only if the Serum Institute of India (SII) ensured compliance with certain conditions, including extra care during screening, that it provide additional information to participants and that it closely monitor adverse events. The SII has reportedly been also asked to submit medication used for the management of potential adverse consequences.
The DCGI had on 11 September asked the Serum Institute of India to suspend any further recruitment for Phase 2 and 3 trials of the vaccine candidate, in the wake of the British-Swedish pharmaceutical giant placing its study on hold in other countries after a participant reported an “unexplained illness” during the process.
The trials in the UK resumed over the weekend after Medicines Health Regulatory Authority (MHRA) said that they were safe. The SII approached the Indian authorities itself on Tuesday, seeking permission to resume enrolment for the study and clinical trials in the country.
Meanwhile, India’s total coronavirus infections breached the five million-mark, according to the latest update from India's Ministry of Health and Family Welfare. According to government data, almost a million new cases were added in the last 11 days.
India’s coronavirus caseload is the second worst in the world, with only the US having reported more infections than the South Asian country.