Defining the Zero Dose Child: A Comparative Analysis of Two Approaches and Their Impact on Assessing the Zero Dose Burden and Vulnerability Profiles across 82 Low- and Middle-Income Countries.

While there is a coordinated effort around reaching zero dose children and closing existing equity gaps in immunization delivery, it is important that there is agreement and clarity around how 'zero dose status' is defined and what is gained and lost by using different indicators for zero dose status. There are two popular approaches used in research, program design, and advocacy to define zero dose status: one uses a single vaccine to serve as a proxy for zero dose status, while another uses a subset of vaccines to identify children who have missed all routine vaccines. We provide a global analysis utilizing the most recent publicly available DHS and MICS data from 2010 to 2020 to compare the number, proportion, and profile of children aged 12 to 23 months who are 'penta-zero dose' (have not received the pentavalent vaccine), 'truly' zero dose (have not received any dose of BCG, polio, pentavalent, or measles vaccines), and 'misclassified' zero dose children (those who are penta-zero dose but have received at least one other vaccine). Our analysis includes 194,829 observations from 82 low- and middle-income countries. Globally, 14.2% of children are penta-zero dose and 7.5% are truly zero dose, suggesting that 46.5% of penta-zero dose children have had at least one contact with the immunization system. While there are similarities in the profile of children that are penta-zero dose and truly zero dose, there are key differences between the proportion of key characteristics among truly zero dose and misclassified zero dose children, including access to maternal and child health services. By understanding the extent of the connection zero dose children may have with the health and immunization system and contrasting it with how much the use of a more feasible definition of zero dose may underestimate the level of vulnerability in the zero dose population, we provide insights that can help immunization programs design strategies that better target the most disadvantaged populations. If the vulnerability profiles of the truly zero dose children are qualitatively different from that of the penta-zero dose children, then failing to distinguish the truly zero dose populations, and how to optimally reach them, may lead to the development of misguided or inefficient strategies for vaccinating the most disadvantaged population of children.