How much evidence demonstrating a vaccine’s safety and efficacy should be required before it is considered “essential”? In their paper for Health & Human Rights, Maxwell Smith, Katrina Perehudoff and colleagues attempt to find an answer to this question. They conclude that COVID-19 vaccines authorized for emergency use should not necessarily be precluded from being considered as essential medicines candidates, but rather be considered for essential medicine status only if they have undergone a systematic, consistent, transparent, and coordinated process for being assessed and listed for emergency use.
The World Health Organization’s (WHO) concept of “essential medicines” suggests that COVID-19 vaccines that satisfy priority health care needs and have public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness should be considered strong candidates for being listed as “essential medicines.” 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.
In order to answer the question whether COVID-19 vaccines should be consideren "essential", Katrina Perehudoff, Maxwell Smith and colleagues first outline the implications of right to health standards for essential medicines, then consider whether EUA COVID-19 vaccines should ever be considered as candidates for essential medicines status, and conclude by evaluating WHO’s Emergency Use Listing procedure as a potential mechanism for categorizing emergency use vaccines for the purposes of being considered for essential medicines status.
The article is published in the Health and Human Rights Journal on 2 June 2021.