Serum Institute puts India trials of AstraZeneca's COVID-19 vaccine on hold
Earlier, the central drug regulator had issued a show-cause notice to the SII for not informing it about pharma giant AstraZeneca pausing the clinical trials.
Earlier, the central drug regulator had issued a show-cause notice to the SII for not informing it about pharma giant AstraZeneca pausing the clinical trials.
Earlier, the central drug regulator had issued a show-cause notice to the SII for not informing it about pharma giant AstraZeneca pausing the clinical trials.
Serum Institute of India (SII) has put trials of AstraZeneca's COVID-19 vaccine candidate on hold until the British drugmaker restarts the trials, Serum said on Thursday.
"We are reviewing the situation and pausing India trials," Serum said in a brief statement.
AstraZeneca said on Tuesday it had paused trials of its experimental coronavirus vaccine because of an unexplained illness in a study participant, but its partner Serum had at the time said its trials in India were still ongoing.
Earlier, the central drug regulator had issued a show-cause notice to the SII for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
The Drugs Controller General of India, Dr V G Somani, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
The DGCI sought an immediate reply, saying else "it shall be construed that you have no explanation to offer and action deemed fit will be taken against you".
In the show-cause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where they were conducted i.e. USA, UK, Brazil and South Africa.
Regarding the show cause notice issued by DCGI, Serum Institute of India (SII) said in a statement, "We are going by DCGI's direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocol."
Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, a British-Swedish biopharmaceutical giant in a tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was "an unexplained illness".
(With inputs from Reuters and PTI)