Astrazeneca vaccine trial in UK stopped after volunteer fell ill (Representative)
New Delhi:
The Serum Institute of India (SII) is set to restart coronavirus vaccine trials, pending permission from the General Medicines Controller of India (DGCI), the manufacturer said in a statement Saturday night.
IBS had suspended recruitment for the Phase 2 and Phase 3 trials in India of the Covishield vaccine, which is being developed by pharmaceutical giant AstraZeneca and the University of Oxford, after concerns about the health of a trial participant in the United Kingdom. British regulators ordered the trials in the UK to stop.
On Wednesday, the DGCI sent a proof of cause notice to the SII, asking why the trials that had been stopped elsewhere were continuing. The DGCI also demanded a report detailing the symptoms of the UK patient and directed the IBS to increase follow-up for trial patients who had already been vaccinated.
In response to the advisory, the SII said that there had been no health or safety concerns in the Indian trials so far. However, the Data Security Monitoring Board recommended stopping more registrations.
In response to the statement that SII is ready to restart testing, Adar Poonawalla, CEO and founder of the company, tweeted.
“As I mentioned earlier, we must not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we must not skew the process and must respect the process to the end. Good news, @ UniofOxford.” , said.
As I mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we must not skew the process and we must respect the process to the end. Good news, @UniofOxford. https://t.co/ThIU2ELkO3
– Adar Poonawalla (@adarpoonawalla) September 12, 2020
The DGCI had granted the SII permission to conduct Covishield Phase 2 and Phase 3 combined human trials on 2 August.
Hours earlier, AstraZeneca said it had received permission to restart its tests in the UK. The company had “voluntarily stopped” its trials after one of the participants fell ill.
“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have been 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. release.
The company declined to disclose details about the disease, but said it will “continue to work with health authorities around the world and guide itself on when other clinical trials can resume.”
AstraZeneca’s candidate vaccine is one of nine worldwide currently in phase 3 end-stage human trials. AZD1222 vaccine uses a weakened version of a common cold-causing adenovirus designed to encode the spike protein. that the Covid-19 coronavirus uses to invade cells.
More than 28 million cases of Covid have been reported worldwide since the pandemic broke out in Wuhan in China in December last year. In India, the second most affected country, there are almost 4.7 million cases. Global deaths have passed the nine million mark; India has been responsible for more than 77,000 of those deaths.
With contributions from AFP
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