After Astrazeneca resumed testing of the Oxford University coronavirus vaccine in the UK, the Serum Institute of India said on Saturday it will restart the trial in the country once allowed by the main drug regulator. Commenting on the resumption of the trial, Adar Poonawalla, executive director of the Serum Institute of India, said: “We should not jump to conclusions until the trials are fully concluded.”
AstraZeneca halted its trials Tuesday night after observing “a single unexplained illness event that occurred in the UK phase III trial.” Later, the Pune-based drug maker suspended clinical trials of the Oxford COVID-19 vaccine in the country. made the decision based on the instructions of the Controller General of Medicines of India (DCGI) VG Somani. On Wednesday, the central drug regulator issued a show of cause notice to the company, asking it to explain why it was not informed that AstraZeneca paused the trial of the Oxford coronavirus vaccine candidate.
Commenting on the resumption of the trial in India, Poonawalla said: “The recent chain of events is a clear example of why we must not skew the process and we must respect the process to the end.”
The University of Oxford said in a statement that the UK regulator had recommended that the trials be resumed after an independent review of safety data. “The UK committee has concluded its investigations and recommended to the MHRA that it is safe to resume trials in the UK,” Astrazeneca said.
AstraZeneca’s pause of an experimental vaccine for coronavirus after a participant’s illness is a “wake-up call,” but should not discourage researchers, the World Health Organization (WHO) chief scientist previously said. “This is a wake-up call to recognize that there are ups and downs in clinical development and that we have to be prepared,” said Soumya Swaminathan.
Serum Institute of India partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate for low- and middle-income countries. The Pune-based vaccine manufacturer previously shortlisted 17 sites in India for the phase II clinical trial of the COVID-19 vaccine. At least 1,600 candidates between the ages of 18 and 55 will participate in the trial.
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