Serum needs nod from UK, India authorities to resume COVID-19 trials

After AstraZeneca resumed coronavirus vaccine trials in United Kingdom, Serum Institute of India (SII) said it would only resume trials after permission from Drugs Controller General of India (DGCI). "Once DCGI (Drugs Controller General of India) gives us permission to restart the trials in India, we will resume the trials," SII CEO Adar Poonawalla tweeted on Saturday.

Poonawalla also said: "As I'd mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end."

AstraZeneca and the University of Oxford earlier on Saturday said that clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe.

The human trials resumed days after a pause had been announced in the trials after an adverse reaction in one of the participants.

AstraZeneca and the University of Oxford, as the trial sponsor, said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.

"Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the MHRA that it was safe to do so," AstraZeneca said in a statement.

"AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials.

"The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic," the company said.

On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees, and international regulators.

SII will require clearance from the Data and Safety Monitoring Board (DSMB) in the UK and DSMB India before resuming recruitment for conducting COVID-19 trials for the Oxford-AstraZeneca coronavirus vaccine in India, an order issued by the Drugs Controller General (India) and the Central Licensing Authority said.

Also read: AstraZeneca's COVID-19 vaccine clinical trials resume in UK