'Ready to restart': Serum Institute after UK Covid vaccine trials resume
New Delhi, Sep 12: Pharma company AstraZeneca's India partner Serum Institute said it will also restart the trials once the Drug Controller General of India (DGCI) gives the nod.
"Once DCGI will give us the permission to restart the trials in India, we will resume the trials," Serum Institute of India (SII) said in a statement.
In a tweet, SII CEO Adar Poonawalla 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. Good news, @UniofOxford."
The statement came in response to AstraZeneca's announcement that vaccine trials have resumed in the UK.
"Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so," the company said in a statement.
The human trials resumed days after a pause had been announced in the trials after an adverse reaction in one of the participants.
The SII had suspended recruitment for Phase 2 and Phase 3 India trials of the Covishield vaccine - being developed by pharma giant AstraZeneca and the University of Oxford - after concerns over the health of a trial participant in the United Kingdom. British regulators directed the UK trials to be halted.
Following the suspension, the DCGI directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the vaccine candidate.
The central drug regulator authority had 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".