New Delhi: Pune-based Serum Institute of India (SII) is halting its clinical trials of the Oxford University’s leading Covid-19 vaccine candidate after safety concerns emerged.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following Drug Controller General of India (DCGI)’s instructions and will not be able to comment further on the same,” SII announced in a tweet through its official twitter account Thursday.
We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.#SII #Latestnews #Covid_19 pic.twitter.com/CUeFY5oLus
— SerumInstituteIndia (@SerumInstIndia) September 10, 2020
SII, which earlier said it had not faced any issues in its trials so far, received a show cause notice from the DCGI Wednesday after pharma giant AstraZeneca — the co-developer of the Oxford University’s vaccine candidate — announced it was temporarily halting its clinical trials.
In an announcement Tuesday, AstraZeneca said a person participating in the studies had developed an “unexplained illness”. “The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials,” the Swedish-British drugmaker said in the statement.
After AstraZeneca’s announcement, SII said it had not received any instructions from the DCGI, the country’s apex drug and vaccine regulator, to pause the trials.
However, V.G Somani, the DCGI, had sent a notice Wednesday evening seeking an explanation from SII on why it had not informed the regulator about the pausing of clinical trials and shot a “show-cause” notice to the firm.
Somani highlighted in the letter that one of the conditions to start the trial was that “the clinical data generated in this trial shall be considered along with the data from AstraZeneca, Oxford University clinical trial”.
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‘Reply immediately or face action’
Somani has said in the letter, accessed by ThePrint, that he and the central licensing authority — which approved the ongoing trial — “hereby give you an opportunity to show cause” that “why the permission granted to you shall not be suspended till patient safety is established.”
The regulator warned the vaccine maker of action if it failed to revert immediately. “Your reply shall reach undersigned immediately, else it shall be construed that you have no explanation to offer and action deemed fit will be taken against you,” Somani said.
The letter was titled ‘Safety concerns of ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) during ongoing clinical trial — show cause notice issued’.
On 2 August, the company had received the go ahead from Indian government to kickstart the trial to determine the “safety and immunogenicity” of the vaccine.
According to SII’s proposal for approval submitted to the DCGI, over 1,600 people were to participate in the trials in over 20 cities across India.
SII had announced a tie-up with AstraZeneca in June for the vaccine candidate with an aim of producing the Covid shot for low- and middle-income countries.
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