Ethical and policy considerations for COVID-19 vaccination modalities: delayed second dose, fractional dose, mixed vaccines.

2021 
As a growing number of vaccines for COVID-19 gain emergency use designation, including emergency use authorisation and conditional marketing authorisation under different jurisdictions, the WHO Strategic Advisory Group of Experts on Immunization (SAGE)1 has issued a number of guidance papers for their recommended use. The overall framework is set out in an Evidence Framework document,2 and has currently been applied to several vaccines.3–5 The framework is also guided by the SAGE Values Framework6 and prioritisation guidelines.7 The overarching aim of the Evidence Framework is to make recommendations based on the principles of evidence-based medicine. COVID-19 immunisation is a very fast-moving area, with a highly varied landscape, as new vaccines become available, yet supply lags a long way behind global demand. The emergence of new variants adds further complexity. Each country is in its own unique circumstances and while scientific knowledge is increasing day by day, there are many scientific uncertainties, and few easy decisions. Even taking current scientific knowledge into account, very often decisions involve trade-offs with health and non-health risks and benefits on both sides, calling for judgements to be made by policymakers. It is not the aim of this paper to provide a solution to the very difficult questions different countries face, but to provide guidance on the considerations that ethically should be taken into account in making such decisions about whether to proceed with different modalities. By ‘different modalities’ we mean proposals for administering vaccines in ways that have not been recommended by the manufacturer, or approved by authoritative international bodies such as WHO, or supported by strong emerging evidence, but are being considered in the search for the best overall set of public policies to bring the pandemic under control.
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