"Emergency Use Designation of COVID-19 candidate vaccines: Ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding"
Policy brief by the World Health Organization (WHO), 18 December 2020
Associate Professor Calvin Ho is a member of the WHO ethics expert group which produced the policy brief. He also shared on the ethical and regulatory issues in the vaccine race in a webinar on "International Law, Science and Technology in the Time of COVID-19" hosted by the Lauterpacht Centre for International Law of the University of Cambridge on 4 December 2020. Click here for the recording.
Introduction: The grave public health threat posed by COVID-19 has spurred the development of dozens of COVID-19 candidate vaccines, and the conduct of numerous accelerated COVID-19 vaccine trials, many of which are in Phase 2/3 of testing. Given this severe threat, some drug regulatory authorities including the United States Food and Drug Administration (FDA) and the European Union’s European Medicines Agency (EMA) have indicated that, if interim data are sufficiently compelling, they are prepared to issue COVID-19 candidate vaccines conditional / emergency / early approval prior to completion of Phase 3 trials. In such instances the regulatory authority signals that the balance of risk and benefit to designated target populations justifies deployment of the vaccine pending the registration / licensure of that product on public health grounds. Similarly, to assist World Health Organization (WHO) Member States and UN procurement agencies in decision-making on the acceptability for use of specific products in the context of a public health emergency, WHO has established an Emergency Use Listing (EUL) procedure to expedite the availability of interventions needed in public health emergency (PHE) situations. The validity of a WHO EUL in the context of a public health emergency is generally 12 months. All decisions to grant an EUL are reassessed at 12 months (or sooner, if further data become available that could alter the original opinion). EUL is contingent upon the vaccine developer completing the development of the product and its trial, and submitting the candidate vaccine for registration/licensure and WHO prequalification. EUL is not equivalent or an alternative to WHO prequalification, and should not be thought of as such. For the purposes of this policy brief, all mechanisms that facilitate the public accessibility of investigational vaccines prior to the conclusion of their respective clinical trials or their licensure, shall hereinafter collectively be referred to as ‘Emergency Use Designation’ or EUD... Click here to download the policy brief.