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SII halts Oxford vaccine trials after global pause

By HT Correspondent, New Delhi
PUBLISHED ON SEP 11, 2020 12:00 AM IST

Pune-based pharma firm Serum Institute of India (SII) said on Thursday it has paused the India trials for the Covid-19 vaccine candidate developed by Oxford and AstraZeneca, a day after the United Kingdom-based developers announced a global halt of the human experiments because a patient developed a potentially serious condition.

SII’s move came hours after India’s drugs regulator issued a show-cause notice to the company for failing to inform it about the suspension of the global trials of AZD1222 (as the vaccine candidate is called) , which is largely seen as the front runner in the race to develop a vaccine for Covid-19 , and is being tested around the world.

Till Wednesday, SII said it would go ahead with the trials since no adverse reactions were seen in India. AstraZeneca said late on Tuesday it paused trials in the US, UK, Brazil, and South Africa following reports of a UK participant developing an unexplained severe adverse reaction.

This prompted a notice from the Drugs Controller General of India (DCGI), which asked SII to explain why its permission for phase II and phase III trials should not be withdrawn for failing to report an adverse reaction. In response, SII said in a statement on Thursday: “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drugs Controller General of India’s instructions and will not be able to comment further on trials…”

“Normally if there has been a serious adverse event reported from any of the trial sites then safety concerns need to be allayed. It may or may not be vaccine induced but that needs to be investigated, and patient safety established,” said an official in the drugs control department, not wanting to be named.

“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,” according to the show-cause notice issued by DCGI’s Dr VG Somani.

The DCGI sought an immediate reply to the notice saying else “it shall be construed that you have no explanation to offer and action deemed fit will be taken against you”.

The Pune-based vaccine manufacturer got DCGI’s permission on August 2 to conduct Phase 2 and 3 clinical trials of the AstraZeneca Covid-19 vaccine, which was developed in partnership with the University of Oxford. SII is one of the world’s largest manufacturers of vaccines in terms of capacity and its role is crucial in building supplies when a vaccine is finally approved.

The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified. The first dose of the vaccine as part of the phase II, III human trials to check its efficacy began at Bharati Vidyapeeth Deemed University Medical College and Hospital in Pune last month.

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