The central drug regulator Drugs Controller General of India (DCGI) is likely to decide on Serum Institute of India's (SII) clinical trials of the coronavirus vaccine on Monday. On Saturday, the Pune-based drug manufacturer said that it will resume clinical trials of AstraZeneca's COVID-19 candidate after getting permission from the Drug Controller General of India (DCGI).
Meanwhile, pharma giant AstraZeneca has resumed the clinical trial of its COVID-19 vaccine in the UK, following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials are safe.
In India, Pune-based Serum Institute of India (SII) is conducting Phase 2/3 human trials for the COVID-19 vaccine developed by the University of Oxford and AstraZeneca.
The human trials in UK resumed days after getting paused due to a reported side effect in a patient.
Consequently, the DCGI also directed SII to suspend the trial until further notice. The DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm said it was pausing the clinical trials in India.
On August 2, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
The University of Oxford, which developed the vaccine in partnership with AstraZeneca said that some 18,000 people have so far received the vaccination in trials.
AstraZeneca's potential coronavirus vaccine is among the frontrunners in the race toward a safe and effective vaccine that could put a dent in the global pandemic. The company launched its late-stage trials at the end of August. Officials from the World Health Organisation had previously hailed AstraZeneca's vaccine candidate as one of the most promising currently in development.