New Delhi: The central drug regulator has not informed about the closure of clinical trials of the Oxford Covid-19 vaccine in other countries by the pharma company AstraZeneca and “news of serious adverse effects” of the vaccine. Serum Institute of India (SII) has been issued a show-cause notice. There have been reports that a trial of the Covid-19 vaccine has been stopped after its adverse effects on a person involved in a vaccine trial in the UK, followed by a show-cause notice to SII.
This vaccine is being developed by the University of Oxford. Drug Controller General of India, Dr. V.G. Somani has asked the Serum Institute in the show cause notice not to suspend the permission given for Phase II and Phase III vaccine testing in the country until patients’ safety is guaranteed.
As per the copy of the show-cause notice, “The Serum Institute of India Private Limited has not yet reported to the Central License Authority that AstraZeneca has suspended vaccine testing in other countries and its adverse effects on patients.” No report has been submitted in this regard. ” The notice asks the Serum Institute under provision 30 of the New Drugs and Clinical Trials Rules, 2019, why the approval of the test given on August 2 should not be postponed until the safety of the patients is decided.
The DGCI summoned the immediate reply, saying, “If we do not get the answer, it will be assumed that you have nothing to say and then appropriate action will be taken against you.” In the show cause notice, the regulator has also said that all the countries where clinical trials were going on have been stopped. Vaccines were also being tested in the US, UK, Brazil and South Africa.
Regarding the show cause notice issued by DCGI, Serum Institute of India said in a statement, “We are working as per DCGI’s instructions and we have not been asked to stop the trial yet. If DCGI has any security concerns, we will follow their instructions and follow the standard procedure. ”
The regulator last month allowed the Pune-based Serum Institute to conduct second and third stage clinical trials of corona virus infection vaccine. The British-Swedish biopharma company AstraZeneca has tied up with the University of Oxford to produce the vaccine and has cited the reason for stopping the test, saying it is a normal procedure after the “unknown disease”.
The Serum Institute, which tied up with AstraZeneca for the production of the Oxford vaccine, said earlier in the day that it would continue testing in India. Regarding AstraZeneca’s withholding of tests in the UK, the Serum Institute said in its statement, “We cannot comment too much on the trials taking place in the UK, but they are currently withheld for review and are expected to be soon Will start.” The statement said, “As far as testing in India is concerned, it is ongoing and we have not had any issues so far.”
