SII says it is ready to restart COVID vaccine trials if DCGI gives nod

The Serum Institute of India (SII) has expressed willingness to restart coronavirus vaccine trials, it said in a statement on Saturday.

The permission of the Drug Controller General of India (DCGI) is required to restart the trials.

The SII had to stop recruitment for Phase 2 and 3 India trials of the Covishield vaccine after a trial participant faced health issues in the UK.

(The vaccine is being developed by pharma giant AstraZeneca and the University of Oxford). After British regulators directed the UK trials to be halted, the DCGI issued a show-cause notice to SII and asked why it was continuing the trials.

Related news: DCGI directs Serum Institute to stop Phase 2, 3 trials of COVID vaccine

The DGCI also sought a report on the symptoms of the UK trial volunteer and asked the institute to increase ‘monitoring’ of trial patients already been vaccinated.

The Data Safety Monitoring Board, an independent group of experts who monitor patient safety and treatment efficacy, also recommended that the trials be suspended. The SII had but maintained that no safety or health issues were noticed in the India trials. Adar Poonawalla, the CEO and founder of SII, said: “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example why we should not bias the process and should respect the process till the end.”

Aster Zeneca said in a statement that the ‘clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK’ after confirmation by the Medicines Health Regulatory Authority (MHRA).

AstraZeneca’s vaccine candidate is one of nine around the world currently in late-stage Phase-3 human trials.