Pune-based Serum Institute of India has halted the human trial of the AstraZeneca’s COVID-19 vaccine in India. After the trials paused in the UK, the Drug Controller General of India on Wednesday asked the Serum Institute to stop the trial and issued a show-cause notice.
The notice asked why the ongoing human trials of the ‘Covishield’ vaccine has not been stopped as its UK partner AstraZeneca has ‘temporarily pause’ the global clinical trials of the Oxford COVID vaccine candidate.
Serum Institute issued a statement:
The Serum Institute said in a statement, “We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.”
AstraZeneca’s Vaccine trials are underway in many countries:
The Serum Institute is manufacturing Oxford University’s ‘Covishield’ vaccine in collaboration with Britain’s pharma company AstraZeneca. Its trial is going on in many countries including India. Two days ago, the company stopped the trials in Britain. After this company issued a statement, ‘One person fell ill during the trials, after which we have decided to pause the trial.
Vaccine is completely safe: Adar Poonawala
The notice came at a time when SII CEO Adar Poonawala said that clinical trials for Phase II and Phase III would continue uninterruptedly at all 17 locations. While on Tuesday a UK-based volunteer showed unexplained neurological side effects of the drug. Poonawala said, “The vaccine is completely safe. As far as Indian trials are concerned, we have not faced any kind of trouble.’
9 vaccine candidates in third phase trials:
AstraZeneca started the registration of 30,000 volunteers for the third phase clinical trial from 31 August. AstraZeneca is one of 9 companies whose vaccine trials are in the third or last phase.