Should COVID-19 Vaccines Authorized for Emergency Use Be Considered “Essential” Medicines?

A critical debate in the race to develop, market, and distribute COVID-19 vaccines could define the future of this pandemic: How much evidence demonstrating a vaccine’s safety and efficacy should be required before it is considered “essential”? If a COVID-19 vaccine were to be designated an essential medicine by the World Health Organization, this would invoke special “core” human rights duties for governments to provide the vaccine as a matter of priority irrespective of resource constraints. States would also have duties to make the vaccine available in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at an affordable price. This question is especially critical and unique given that COVID-19 vaccines have in many cases been authorized for use via national emergency use authorization processes—mechanisms that enable the public to gain access to promising medical products before they have received full regulatory approval and licensure. In this paper, we examine whether unlicensed COVID-19 vaccines authorized for emergency use should ever be considered essential medicines, thereby placing prioritized obligations on countries regarding their accessibility and affordability.