Forty days of regulatory emergency use authorisation of COVID-19 vaccines: Interfacing efficacy, hesitancy and SDG target 3.8

Abstract

ABSTRACT The year 2020 will be synonymous with the coronavirus disease 2019 (COVID-19) for many global citizens. Millions have died from and tens of millions more have been infected globally by the COVID-19 pandemic. This has led to an urgent search for COVID-19 vaccines and treatments by the scientific and political communities and civil society. Through elements of events study and document and critical discourse analysis, this paper investigates the COVID-19 vaccines’ regulatory emergency use authorisation and/or conditional marketing authorisation (regulatory authorisation) regimes and the contestations thereof. The key finding is that there was a regulatory authorisation rush, with at least 62, mostly high-income countries, doing so in 40 days from 2 December 2020–10 January 2021. This has led to one senior USA official describing the United Kingdom pioneer regulatory authorisation of the Pfizer-BioNTech vaccine as ‘too quick’. Regulatory authorisation regimes took place amid severe civil society contestations and appropriate political pressure. The paper recommends that as the COVID-19 vaccines’ regulatory authorisation continue in 2021, national vaccines and treatments regulatory bodies must be informed by science, with governments, civil society, politicians and other key stakeholders taking responsibility to educate the masses and continue taking the necessary precautions.