Serum Institute of India (SII) has put trials of AstraZeneca’s COVID-19 vaccine candidate on hold until the British drugmaker restarts the trials, Serum said on Thursday. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drug Controller General of India's (DGCI) instructions and will not be able to comment further on trials," Serum said in a brief statement.
The SII decision came a day after the DCGI issued a show-cause notice to the vaccine maker for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events". The British-Swedish biopharmaceutical major AstraZeneca put a pause on the COVID-19 trials after a UK patient reported illness.
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.
The Oxford vaccine was described by the World Health Organisation (WHO) as the world's leading candidate and the most advanced in terms of development. Pausing of trials could delay the vaccine development process as Serum Institute is the frontrunner when it comes to companies producing COVID-19 vaccines in India.
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".
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