Serum Institute Suspends AstraZeneca COVID-19 Vaccine Trials in India Until DCGI Notified
The Serum Institute of India (SII) has suspended trials of AstraZeneca’s COVID-19 vaccine candidate until the British drugmaker restarts trials, Serum said Thursday. “We are reviewing the situation and halting the India trials until AstraZeneca restarts the trials. We are following the instructions of the Comptroller General of Drugs of India (DGCI) and will not be able to comment further on the trials,” Serum said in a brief statement.
The SII decision came a day after DCGI issued a notice of demonstrative cause to the vaccine manufacturer for failing to inform it that AstraZeneca was suspending clinical trials of the Oxford candidate vaccine in other countries, and also for failing to submit a analysis of victims of the “serious report”. adverse events. “Major British-Swedish biopharmaceutical company AstraZeneca put COVID-19 trials on hold after a UK patient reported illness.
Last month, the DCGI had granted Pune-based IBS permission to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
The Oxford vaccine was described by the World Health Organization (WHO) as the world’s leading candidate and the most advanced in terms of development. The trial pause could delay the vaccine development process as the Serum Institute is the pioneer when it comes to companies producing COVID-19 vaccines in India.
AstraZeneca, the British-Swedish biopharmaceutical giant working with Oxford University to produce the vaccine, described the hiatus from trials as “routine” after what was “an inexplicable illness.”
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