The Serum Institute of India (SII) is ready to restart coronavirus vaccine trials – pending permission from the Drug Controller General of India (DGCI) – the manufacturer said in a statement on Saturday evening.
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.
On Wednesday a show-cause notice was sent to the SII by the DGCI, asking why it was continuing trials that had been stopped elsewhere. The DGCI also demanded a report detailing symptoms of the UK patient and directed the SII to increase monitoring of trial patients who had already been vaccinated.
Replying to the notice, the SII said there had been no safety or health issues in the India trials, so far. Nevertheless, the Data Safety Monitoring Board recommended pausing further enrolment.
Responding to the statement that the SII is ready to restart trials, Adar Poonawalla, the CEO and founder of the company, tweeted.
“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,” he 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. Good news, @UniofOxford. https://t.co/ThIU2ELkO3
— Adar Poonawalla (@adarpoonawalla) September 12, 2020
The DGCI had granted SII permission to conduct combined Phase 2 and 3 human trials of Covishield on August 2.
Hours earlier AstraZeneca said it had received permission to restart its UK trials. The company had “voluntarily paused” its trials after one of the participants fell ill.
“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 company declined to disclose details about the illness but said it would “continue to work with health authorities across the world and be guided as to when other clinical trials can resume”.
AstraZeneca’s vaccine candidate is one of nine around the world currently in late-stage Phase 3 human trials.The AZD1222 vaccine uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the Covid-19 coronavirus uses to invade cells.
More than 28 million Covid cases have been reported from around the world since the pandemic broke in China’s Wuhan in December last year. In India – the second most badly hit country – there are nearly 4.7 million cases. Global deaths have crossed the nine million mark; India has accounted for more than 77,000 of those deaths.
With inputs from AFP