COVID-19 vaccine update: Serum Institute gets DCGI notice over Oxford vaccine trial suspension by AstraZeneca abroad

By: |
Updated: Sep 09, 2020 9:48 PM

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 show-cause notice was issued following 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.

The central drug regulator has issued a show-cause 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 show-cause notice was issued following 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.

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.

“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.

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 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.

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”.

Meanwhile, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, on Wednesday said it is continuing with the trials in India.

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 said: “As far as Indian trials are concerned, it is continuing and we have faced no issues at all”.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.

Next Stories
1Coronavirus: Delhi records less than 4,000 daily COVID-19 cases after 5 days; total count past 2.46 lakh
2COVID-19 in Delhi: People letting their guard down is worrying, say experts
3Coronavirus in India: Health Ministry mulls gathering data on suspected COVID-19 reinfection cases, says source