Suspension of Covishield trials in UK spells havoc for Astrazeneca and Serum Institute of India
New Delhi: Owing to a suspected severe adverse reaction on a participant after being administered a booster dose of Covishield, the Drugs Controller General of India (DCGI) has sought a response from the Pune-based Serum Institute of India (SII) regarding the institute's decision to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear.
This comes in the wake of AstraZeneca's decision to immediately halt the clinical human trials of its vaccine candidate 'Covishield' with the University of Oxford after one of the volunteers developed an adverse reaction to the vaccine trial for reasons not yet known. As per the company, the participant is expected to recover.
Explaining why it had to stop the trials immediately, AstraZeneca said it was a "routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."
"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow a review of safety data by an independent committee," the pharma firm added.
Also Read: AstraZeneca Halts COVID19 Vaccine Trial After Recipient Unexplained Illness
However, the domestic pharma giant, SII allegedly did not inform the Indian Drug regulator about pharma giant AstraZeneca suspending 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".
Taking strict note of the reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it, DCGI has now issued a show-cause notice to SII
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.
It further sought an immediate reply saying else "it shall be construed" that the company had no explanation to offer and "action deemed fit" would be taken.
"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 show-cause notice accessed by PTI.
"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 as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.
In the showcase notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted i.e. USA, UK, Brazil, and South Africa. 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.
In response to the notice, SII stated that it will follow the instructions and protocols of the Central Drugs Standard Control Organisation (CDSCO).
"We are going by DCGI's direction and so far we're not told to pause the trials. If DCGI has any safety concerns, we will follow its instructions and abide by the standard protocols, " Serum Institute of India stated.
Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon.
"It further added, "As far as Indian trials are concerned, it is continuing and we have faced no issues at all".
Meanwhile, SII, which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, on September 9 said it is continuing with the trials in India.
SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. SII is currently progressing with the second and third phase study of the vaccine candidate at 17 trial sites across India.
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