Vaccine trial paused

It is vital to address safety concerns

Vaccine trial paused

When a couple of days ago, AstraZeneca put on hold the trial of its leading vaccine, being developed along with Oxford University, over safety concerns following a participant in the UK suffering an unexplained illness, it had a ripple effect, including one in India. This pause to vaccine trials is important as, in accordance with standard norms, it allows the developers to conduct a review of safety data and see if the illness is linked to the vaccine. Even as such setbacks are routine during the making of any new shot, the Covid-weary world hopes that it will not delay the final outcome. However, only time and tests will tell whether this optimism is misplaced or not.

India is keenly observing the developments as it stands to be directly affected. Oxford has partnered with the Pune-based Serum Institute of India (SII) for making the vaccine, Covishield. The institute is enrolling around 1,600 healthy volunteers for the phase 3 trial of Covishield across 17 sites as its efficacy on the local populace too needs to be ascertained. The PGI, Chandigarh, is one of the chosen sites. Coincidentally, the PGI too has pressed the pause button on the recruitment of candidates to be administered the vaccine as it awaits safety approvals for the first 100 participants from the Data Safety and Monitoring Board. This rigorous check and balance is among the country’s strict drug regulation guidelines designed to enable a periodic review and evaluation of accumulated study data for the participants’ safety and progress.

With such a thorough and meticulous system in place, the vaccine may be delayed a bit, but there would be no compromise on its safety before it is declared fit for mass consumption. The SII has assured the Drug Controller General of India that it would not go ahead till all concerns are addressed. It effectively puts to rest the controversy raised by the earlier show-cause notice received by the SII from the DCGI in this context. Meanwhile, the world waits eagerly, and with bated breath, for the final verdict on Covishield, as also the nearly two dozen other vaccines at various stages of trials.

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