Serum Institute of India on Thursday said that it was halting the trial of the Oxford University-Astrazeneca COVID-19 vaccine in India until British-Swedish drug maker restarts the trial. The move came a day after Pune-based vaccine maker received a show cause notice from the Drug Controller’s General of India (DGCI). “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions,” Serum Institute of India said.
The central drug regulator on Wednesday had pulled up the company for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford COVID-19 vaccine candidates in other countries.
On September 8, the clinical trials of one of the Oxford-AstraZeneca’s COVID-19 vaccine were suspended in the United Kingdom after a participant developed an unexplained illness.
In his show-cause notice, Dr V G Somani, Drugs Controller General of India, asked SII 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.
In the show-cause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted i.e. USA, UK, Brazil and South Africa.
US National Institutes of Health Director Francis Collins told a Senate committee Wednesday that AstraZeneca Plc’s closely watched COIVD-19 vaccine trial had been halted due to a “spinal cord problem.”
“This is based on a single severe adverse event which may or may not have anything to do with the vaccine, but it is the best sort of cautious approach to quickly stop and look and see if there’s any other evidence to be concerned about,” Collins told the Senate committee Wednesday.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 vaccine candidate developed by the University of Oxford, for India and low-and-middle income countries. Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.
AstraZeneca Plc chief executive officer Pascal Soriot said the coronavirus vaccine the company is developing with the University of Oxford could still be ready before the end of the year. Global deaths from the COVID-19 pandemic exceeded 900,000.
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