A day after the Serum Institute of India (SII) received a demonstration cause notice from the Controller General of Drugs of India (DCGI), it said it was pausing trials of the Covid-19 vaccine in the country.
IBS is manufacturing the Covishield vaccine at the University of Oxford in collaboration with Britain’s AstraZeneca.
“We are reviewing the situation and stopping the trials in India 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, ”said the Serum institute.
The DGCI issued the notice to the Serum institute for failing to inform them that AstraZeneca has paused clinical trials in other countries and for failing to submit victim analyzes of “reported serious adverse events”.
An immediate response was requested from the Serum Institute saying otherwise: “it will be interpreted that he has no explanation to offer and the measures deemed appropriate will be taken against him.”
“We are following the direction of DCGI and until now we have not been told to stop testing. If DCGI has a security problem, we will follow their instructions and adhere to standard protocols, ”the Serum Institute said after receiving the notice on Wednesday.
The UK-based pharmaceutical giant halted trials of the vaccine on September 8 after one of its recipients in the UK developed an “unexplained illness.”
In India, out of 100 volunteers, 34 were from Bharati Vidyapeeth Medical College and Pune Hospital, who were given vaccine injections after trials for phase 2 began on August 26.
None of these volunteers have shown any signs of health-related complications, and all of their vital parameters appear normal, doctors at the medical school and hospital said.
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