Emergency Use Authorization (EUA) is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions as caused by COVID-19.
However, before grant of the EUA, rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy is conducted.
Safety is particularly critical aspect of this scrutiny and a risk-versus- benefit evaluation is done in the context of a public health emergency.
Full licensure is obtained when the manufacturer submits the complete data. EUA by Indian regulators is aligned with global guidelines.