Serum Institute stops trial of covid19 vaccine in India after DCGI's notice

Serum Institute stops trial of covid19 vaccine in India after DCGI's notice

The Serum Institute of India (SII), which is conducting human trials in India for the Coronavirus vaccine being developed by Oxford University, has halted the trials on Thursday.

The Serum Institute of India said in a statement, "We are reviewing the situation and stopping trials in India until AstraZeneca resumes trials. We are following the instructions of DCGI and taking the tests Will not be able to comment further."

The announcement by Pune-based vaccine manufacturer Drug Control General of India (DCGI) V.G. After the show cause notice was issued by Somani. In this notice, he sought clarification as to why the institute decided to continue the clinical trial of the covid19 vaccine candidate while doubts about patient safety are still unclear.

This notice was issued in view of the incident in which a suspected serious reaction was reported in a Volunteer UK. The Volunteer was awarded a booster dose of Covishield, a vaccine candidate being developed jointly by AstraZeneca and the University of Oxford.

The DGCI wrote in its notice, "Serum Institute of India Private Limited, Pune, has not yet informed the Central Licensing Authority about stopping clinical trials being conducted by AstraZeneca in other countries. Nor did it provide an analysis of the incident In which the Volunteer has had a severe adverse reaction. Continuing testing in the country of Phase 2 and 3 is, therefore, safety incorrect."

The DGCI has further asked the institute why the Authority should not suspend the permission given to SII for clinical trials of Covishield.

The notice further stated, "Keeping in view the above, I, Dr.V.G.Somani, Drugs Controller General of India and Central Licensing Authority, to give you reasons under Rule 30 of New Drugs and Clinical Trial Rules, 2019 Why not say that the permission given to you for a clinical trial on August 2 should be revoked until the security of the patient is established."

Explain that SII is a partner of the Jenner Institute of Oxford University for vaccine testing. It is currently conducting Phase II and Phase III trials of this vaccine candidate at 17 test sites across India.