The serum institute has been ordered to suspend recruitment for Covid vaccine trials. (Representative)
New Delhi:
India’s Comptroller General of Medicines (DCGI) has ordered the Serum Institute of India to suspend until further orders for new recruitments in the Phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate in the context of the giant pharmaceutical AstraZeneca suspending trials in other countries.
In an order, a copy of which was viewed by the PTI, DCGI Dr VG Somani also ordered the Serum Institute of India (SII) on Friday to increase the safety monitoring of subjects already vaccinated as part of the trial. , and submit the plan and report.
Mr Somani also asked the firm to submit authorization from the Data and Safety Monitoring Board (DSMB) in the UK as well as India to obtain authorization from its office (DCGI) before the resumption of future recruitment in the ‘trial.
The central drug regulator DCGI had issued a justification notice to the SII on September 9 for not having informed it of AstraZeneca suspending clinical trials of the candidate vaccine in other countries and also for not having submitted the analysis of victims of “reported serious adverse events”.
After which, the Pune-based company, which has partnered with Anglo-Swedish biopharmaceutical giant AstraZeneca to make the vaccine candidate Oxford, announced Thursday that it was suspending clinical trials in India.
Earlier this week, AstraZeneca said it had halted trials due to “unexplained illness” in a study participant.
“We are reviewing the situation and are suspending testing in India until AstraZeneca restarts testing,” SII said in a statement Thursday.
According to the DCGI order issued on Friday, the SII said in its response that the DSMB did not note any safety concerns from the Indian study (part 1-phase 2) with the safety data from the first dose and seven days after vaccination.
In its response, the SII also said that the DSMB further recommended “to suspend study enrollment until the ongoing investigations into the SAEs reported in the UK study are completed and the sponsor and the UK DSMB are convinced that this poses no safety problem. “.
<< In view of the above, I Dr VG Somani, Comptroller General of Medicines of India, Central Licensing Authority, after careful consideration of your response and the recommendations of DSMB in India, in exercising the powers conferred by Article 30 of the new Medicines and Clinical Trials Regulation, 2019, asks you to suspend any new recruitment into phase 2 and 3 clinical trials until further notice, ”the order states.
“Increase the safety monitoring of subjects already vaccinated with the vaccine being tested and submit the plan and report,” the order added.
On August 2, DCGI cleared the Pune-based IBS to conduct phase 2 and 3 human clinical trials on the coronavirus vaccine candidate.
AstraZeneca, the biopharmaceutical giant linked with the University of Oxford to produce the vaccine, described the trial pause as “routine” following what was “an unexplained illness”.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
