Coronavirus Vaccine Tracker: Serum Institute of India pauses clinical trials after DCGI show-cause notice

A day after the Serum Institute of India received a notice from the Drugs Controller General of India for not halting trials of the Oxford COVID-19 vaccine candidate, the Pune-based company announced that Phase III trials have been paused till AstraZeneca resumes trials. “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front,” the Serum Institute said in a statement on Thursday. The Serum Institute’s announcement comes after   AstraZeneca paused its Phase III trials of the vaccine candidate in the UK on Tuesday due to a participant showing “an adverse reaction” to the vaccine candidate. AstraZeneca has a tie-up with the Oxford University and has partnered with the Indian company to manufacture the vaccine in India post successful trials. Though the British-Swedish company had termed the suspension of trial on Wednesday in the UK a “routine” one following what was “an unexplained illness”, trials of the vaccine candidate have reportedly been suspended in the US, Brazil and South Africa. The Serum Institute of India had on Wednesday said it was going ahead with the trials despite their suspensions abroad. “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon,” the SII said in a statement on Wednesday. Following this, the Drugs Controller General of India, Dr V G Somani, had issued a show-cause notice  on Wednesday to the Serum Institute of India asking 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 2 August shall not be suspended till patient safety is established,” the notice further said. The DGCI had 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 they were conducted, ie, USA, UK, Brazil and South Africa. With inputs from PTI