New Delhi: The Serum Institute of India (SII), which conducted trials in India for the coronavirus vaccine in progression through the University of Oxford, on Thursday suspended clinical trials of the vaccine in India.
In a statement, the Serum Institute of India said: “We are reviewing the scenario and postponing testing in India until AstraZeneca restarts testing. We’re following DCGI commands and we’re not going to comment on them anymore. Tests. “
Those of the Pune-based vaccine manufacturer arrived here a day after India’s Drug Control General (DCGI), VGSomani, sent them a justification report asking them for an explanation of why the institute made the decision to continue the Covid-19 vaccine candidate clinical trial when doubts about patient protection are not yet clear.
The notice was issued following an advertising incident in which one of the uk participants reported a suspected serious adverse reaction when administering a booster dose of Covishield, a vaccine candidate jointly developed through pharmaceutical giant AstraZeneca and oxford University on Tuesday.
“While the Serum Institute of India Pvt Ltd, Pune, has so far not informed the Central Licensing Authority of the suspension of the AstraZeneca clinical trial in other countries, nor has it presented an investigation of those affected by the severe adverse occasion reported with the experimental vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in consultation in the country in soft of protection problems” , dgci’s opinion reads.
DGCI also asked the institute why the authority suspends the irS authorization for Covishield clinical trials.
In the light of the above, I, Dr. VG Somani, Comptroller General of Medicines of India and the Central Licensing Authority, in this document I give you the opportunity to present your case in accordance with Rule 30 of the New Medicines and Clinical Trials Regulations, 2019 why the authorization granted to you on August 2 will be suspended until patient protection is established” Added the ice.
SII is a spouse of the Jenner Institute at Oxford University for vaccine trials. ISS is progressing lately at the time and third phase of the candidate vaccine at 17 control sites across India.