The Serum Institute of India said on Thursday it was halting the University of Oxford-Astrazeneca’s COVID-19 vaccine trial in India until the British-Swedish drugmaker restarts the trial. The move came a day after the Pune-based vaccine maker received a notice of demonstration cause from the Drugs General Inspector of India (DGCI). Serum Institute of India said: “We are reviewing the situation and stopping the trials in India until AstraZeneca restarts the trials. We are following the instructions of DCGI.”
On Wednesday, the central drug regulator detained the company for failing to inform it that pharmaceutical giant AstraZeneca paused clinical trials of Oxford’s COVID-19 vaccine candidates in other countries.
On September 8, clinical trials of one of Oxford-AstraZeneca’s COVID-19 vaccines were suspended in the UK after a participant developed an unexplained illness.
In his show of cause notice, Dr VG Somani, Indian Comptroller General of Drugs, asked IBS why the permission granted to conduct phase 2 and 3 clinical trials of the candidate vaccine in the country is not suspended until establish patient safety.
“Whereas Serum Institute of India Pvt Ltd, Pune, has so far not informed the central licensing authority about the pause of the clinical trial carried out by AstraZeneca in other countries and has not provided an analysis of victims of the serious adverse event informed with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of safety concerns, “said the notice of proof of cause.
In the notice of show of cause, the drug regulator also mentioned that clinical trials have been suspended in the countries where it is being carried out, that is, the US, the UK, Brazil and South Africa.
The director of the US National Institutes of Health, Francis Collins, told a Senate committee Wednesday that AstraZeneca Plc’s COIVD-19 vaccine trial, which had been closely followed, had been halted due to a “spinal cord problem”.
“This is based on a single serious adverse event that may or may not have anything to do with the vaccine, but it is the best kind of cautious approach to quickly stop and see if there is any other evidence to worry about.” Collins told the Senate committee Wednesday.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed by the University of Oxford, for India and 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.
AstraZeneca Plc CEO Pascal Soriot said the coronavirus vaccine the company is developing with Oxford University could still be ready before the end of the year. Global deaths from the COVID-19 pandemic exceeded 900,000.
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