The central drug regulator has issued notice to Serum Institute of India (SII) for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
The notice was issued following reports that human trials of the COVID-19 vaccine candidate being developed by the University of Oxford have been put on hold after a British participant had an adverse reaction to it.
The Drugs Controller General of India, Dr VG Somani, in the notice 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.
“Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns,” said the notice.
“In view of the above, I Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause… why the permission granted to you August 2 shall not be suspended till patient safety is established,” the notice said.
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 notice, the drug regulator mentioned that the clinical trials have been put on hold across countries where it is conducted – the US, the UK, Brazil and South Africa.
Last month, the DCGI had granted permission to Pune-based SII to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, the British-Swedish biopharmaceutical giant in 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”.
SII on Wednesday said it is continuing with the trials in India. “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon,” SII said in a statement. “As far as Indian trials are concerned, it is continuing and we have faced no issues at all,” it said.