Emergency use authorisation of Covid-19 vaccines: An ethical conundrum.

Vashishtha, Vipin M; Kumar, Puneet

Large-scale vaccination with a safe and effective vaccine against Covid-19 is the only way to conquer the ongoing lethal pandemic that has led to extraordinary social and economic upheaval globally. Fortunately, the world is on the verge of developing Covid-19 vaccines in an unprecedentedly short time. More than forty vaccines are in different stages of clinical trials, and a few are in the crucial phase III studies stage. A new demand for emergency use authorisation and rapid deployment of these vaccines before scrutinising phase III trial data is raging in different quarters. Can advancement of the deployment of these vaccines by even a few weeks give us rich public health dividends? Would it be ethical to deploy these novel vaccines based only on the safety and immunogenicity data generated by the phase-I and II clinical trials? Would it be ethical to deny vaccination of vulnerable populations against an untreatable infectious disease despite the availability of reasonably safe and efficacious vaccines for the want of phase III trial data? The answer is not straightforward, as there are many complexities involved. This commentary attempts to discuss some ethical issues involved in a decision to deploy Covid-19 vaccination before phase III trial results are declared.