A day after the Serum Institute of India (SII) was issued a notice by country’s pharma regulator Drugs Controller General of India (DCGI), the pharma company said it was halting the Oxford coronavirus vaccine trials in the country.
According to the reports, Serum Institute of India has put on hold trials of AstraZeneca’s potential coronavirus vaccine in the country until the British drugmaker restarts the trails. The SII is manufacturing Oxford University’s ‘Covishield vaccine’ in collaboration with UK’s AstraZeneca.
We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.#SII #Latestnews #Covid_19 pic.twitter.com/CUeFY5oLus— SerumInstituteIndia (@SerumInstIndia) September 10, 2020
Serum said on Thursday that it was following the DCGI’s directions and added that they would not be able to comment further on the issue.
“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,” the Serum institute said.
DGCI issues notice to Serum Institute
Earlier, the DGCI had issued a notice to the Serum institute for not informing them about AstraZeneca halting their clinical trials in other countries and for not submitting casualty analysis of the “reported serious adverse events”.
The regulator asked SII to demonstrate why its clinical trial license should not be suspended until the safety of the vaccine is established. AstraZeneca had paused its clinical trials worldwide after a participant had developed an unexplained illness during the study.
“We are going by DCGI’s direction and so far we’re not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols,” the Serum institute had said after receiving the notice on Wednesday.
In June, the Pune-based vaccine major had got DCGI nod to conduct Phase 2 and 3 clinical trials of the AstraZeneca coronavirus vaccine. The vaccine being developed by AstraZeneca and Oxford University had raised hopes in the country as it was considered as a possible preventive measure against the Chinese pandemic.