AstraZeneca Pausing Oxford Vaccine Clinical Trials (Representational)
New Delhi:
The central drug regulator has sent a notice to the Serum Institute of India (SII) for not informing it that the pharmaceutical giant AstraZeneca has paused clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting the victim analysis Of the report”. serious adverse events “.
The advisory was issued after reports that human trials of the COVID-19 candidate vaccine being developed by the University of Oxford were suspended after a British participant had an adverse reaction.
The Comptroller General of Medicines of India, Dr. VG Somani, in the notice asked the SII why the permission granted to conduct the phase 2 and 3 clinical trials of the candidate vaccine in the country is not suspended until the establishment of the patient safety.
“Whereas, Serum Institute of India Pvt Ltd, Pune, has so far not informed the central licensing authority about the pause of the clinical trial conducted by AstraZeneca in other countries and has not provided a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of safety concerns, “the notice reads.
“In view of the above, I, Dr. VG Somani, Indian Comptroller General of Drugs and Central Licensing Authority, hereby give you the opportunity to show cause … why the permission granted to you on 2 August will not be suspended until patient safety is established, “the notice read.
The DGCI requested an immediate response saying otherwise “it will be interpreted that you have no explanation to offer and the measures deemed appropriate will be taken against you.”
In the notice, the drug regulator mentioned that clinical trials have been suspended in the countries where it is being conducted: the US, the UK, Brazil and South Africa.
Last month, the DCGI had granted Pune-based IBS permission to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, the British-Swedish biopharmaceutical giant working with Oxford University to produce the vaccine, described the hiatus from trials as “routine” after what was “an inexplicable illness.”
The SII said Wednesday that it is continuing with trials in India. “We cannot comment much on the UK trials but they have been paused for further review and hope to restart soon,” SII said in a statement. “As far as the Indian trials go, it continues and we have not faced any problems,” he said.
“We (Serum Institute of India) followed DCGI’s instructions and we were not ordered to stop the trials. If DCGI has any safety concerns, we will abide by their instructions and comply with standard protocols,” SII tweeted.
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