“We are following the DCGI’s instructions and will not be able to comment further on the trials. You can connect with the DCGI for more updates,” he added.
On Wednesday, the DCGI had issued show cause notice to SII, asking why it should not suspend permission granted for trials here until patient safety is established.
Somani had also noted in the letter that SII had not submitted a casualty report of the serious adverse event of the investigational vaccine for continuation of Phase II and III trials here. AstraZeneca India said that there were no further statements from the company at this point in time.
The company had said earlier that an ‘independent committee’ would review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. Terming it as ‘routine action’, the firm had said that in large clinical trials, illnesses do happen unexpectedly.
“AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline,” it said.
AstraZeneca India did not comment.
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.