Serum Institute pauses Covishield vaccine trials in India
UK-based pharma giant AstraZeneca paused vaccine trials after one of the recipients in the United Kingdom developed an ‘unexplained illness’ after being given a dose of the vaccine.
A day after the Serum Institute of India (SII) was issued a show cause notice by the Drugs Controller General of India (DCGI), it said it was pausing Covid-19 vaccine trials in the country.
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 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.
The DGCI issued the notice to the Serum institute for not informing them about AstraZeneca pausing the clinical trials in other countries and for not submitting casualty analysis of the “reported serious adverse events”.
An immediate reply from the Serum institute was sought saying else “it shall be construed that you have no explanation to offer and action deemed fit will be taken against you”.
“We are going by DCGI’s direction and so far were 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.
The UK-based pharma giant paused the trials of the vaccine on Sept 8 after one of its recipients in the United Kingdom developed an ‘unexplained illness’.
In India, out of the 100 volunteers, 34 were from Bharati Vidyapeeth Medical College and hospital in Pune, who have been administered vaccine shots after trials for phase 2 began on August 26.
None of these volunteers have shown any sign of health-related complications, with all their vital parameters appearing normal, doctors at the medical college and hospital said.