DCGI Questions Serum On AstraZeneca Pausing Trials For Its Covid Vaccine

India’s drug regulator has issued a showcause notice to Serum Institute of India for not informing it about AstraZeneca Plc pausing the clinical trials for a Covid-19 vaccine they are developing together.

AstraZeneca Plc stopped giving shots of its experimental coronavirus vaccine after a person participating in one of the company’s studies got sick, a potential adverse reaction that could delay or derail efforts to speed an immunisation against Covid-19. On Wednesday, Serum Institute said it is continuing with the trials in India.

In showcause notice, Drugs Controller General of India Dr VG Somani asked Serum Institute as to why the permission granted for conducting Phase II and III clinical trials of the vaccine candidate in India be not suspended till patient safety is established.

“Whereas, Serum Institute of India Pvt. Ltd., Pune, till now has not informed the central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of Phase II and III clinical trials of the subject vaccine in the country in light of the safety concerns," the showcause notice, accessed by the Press Trust of India, stated.

The DGCI sought an immediate reply saying otherwise “it shall be construed that you have no explanation to offer and action deemed fit will be taken against you”.

In the showcause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted, i.e. U.S., U.K., Brazil and South Africa.

The DCGI had last month granted permission to Serum Institute to conduct Phase II and III human clinical trials of the coronavirus vaccine candidate. AstraZeneca is in tie-up with Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was an unexplained illness.