Patient activist groups express relief over pause of Covishield trials in India

Various patient groups have voiced their relief over the move to pause clinical trials of Covishield, the AstraZeneca-Oxford University COVID-19 candidate in India.

Prof Bejon Misra, Founder Director, Patients Safety and Access Initiative said, “It is better late than never. However, we have to learn a lesson from such episodes that in future the regulator has to be extremely alert with the development around the world so that the patients in countries like India are not made to compromise due to such delayed responses.”

He further added, “The patient groups in India were wondering about why there was a delay from the Indian regulator to adequately respond on such critical matters concerning safety.

Amar Jesani, Editor, Indian Journal of Medical Ethics said, “At last, for a change, the DCGI cracked the whip and the SII has paused vaccine trial. However, by its irresponsible belligerence, the SII and its head have proved that they hardly care for the safety of participants. This will discourage people from volunteering to participate. And also reduce people’s trust in the vaccine. Those responsible for delay in pausing the trial must be made accountable.”

Dr Kiran Marthak, Director, Veeda Clinical Research said, “During any clinical trial if anything happens unexpectedly, and considering the pandemic, one has to take extra precautions. In such circumstances, it requires the opinion from an independent body/ committee to move forward. It is for the safety of the subjects and there is no cause of any worries, it is very much normal. For any clinical trials with NCE/vaccine, the Data and Safety Monitoring Board (DSMB) in fact recommended, which meets frequently to discuss the data generated and the safety of the subjects in clinical trials.”

The Serum Institute of India is involved in manufacturing Oxford University’s Covishield vaccine in collaboration with UK’s AstraZeneca. Earlier this week, AstraZeneca had paused the trials abroad because of “an unexplained illness” in a participant in the study. After a show cause was issued to the Serum Institute of India (SII) by the Drugs Controller General of India (DCGI) for not informing about this development, the Pune-based company has paused the coronavirus vaccine clinical trial in the country.