Oxford-AstraZeneca Covid vaccine error: What is the way forward for Covishield in India

Oxford-AstraZeneca Covid-19 vaccine’s efficacy results were based on around 3,000 volunteers who were not supposed to be inoculated with a lower dose of the vaccine. The Oxford in a statement said the doses administered to a batch of volunteers for the phase 3 human trials were overestimated.

There could be two potential reasons behind this mistake committed by the Oxford-AstraZeneca. One there could be haste in completing the human trial. Secondly, competition among pharma firms trying to attract the vaccine market at the earliest, according to an Indian Express report.

The human trials phases are integral and pivotal parts of Coronavirus vaccine development. These phases are absolutely crucial as these phases determine the dosage, safety, and efficacy based on which any candidate gets approval for usage. Protocols and norms that act as guidance remain uniform across all volunteers. Protocol deviations are quite common. But it is a sign to stop and assess the situation. Hence data monitoring is absolutely crucial, the Indian Express report says.

However, India has a relief given the efficacy data is based on the results of UK trials. However, this error underlines the need for greater transparency even for Indian companies that have been conducting trials. Apart from this Regulators will need to review the data more critically. Serum Institue of India, which is conducting human trials of Covishield, must use the available data to chalk down a protocol for additional studies to test the Coronavirus vaccine for appropriate dosage of the Covid-19 vaccine candidate, the Indian Express report says.