Boston Children's Hospital

Optimizing use of BCG vaccine to reduce global infant mortality

Infectious and parasitic diseases

We will enhance neonatal protection against deadly and debilitating infections using live tuberculosis vaccines, and broadly disseminate vaccine benefits via a robust media campaign.

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Project Summary

Problem: Millions of infants worldwide suffer severe disability or death due to infection every year. Given the scale and urgency of this problem, a solution must be effective, economical and immediately deployable.Solution: Live Bacille Calmette-Guérin (BCG) tuberculosis vaccines have unexpected beneficial effects, reducing susceptibility to infection from a range of microbes beyond tuberculosis. However, diversely produced BCG vaccines, currently used interchangeably and given across the first weeks of life, vary markedly in their benefit which is greatest when given at birth. We will (a) compare BCG vaccines head-to-head given at birth across continents to establish optimal formulation and timing, (b) scale our solution internationally, and (c) implement targeted media campaigns to enhance impact.Impact: We will optimize formulation and timing for the 100 million infants receiving BCG each year, thereby providing a rapid, effective and feasible solution to early life infection and saving many lives at affordable cost.

Problem Statement

Infection strikes the young and poor most frequently and severely. Worldwide, every year, infection harms millions of newborns and young infants leading to death or severe disability. Despite dramatic increase in child (e.g. under 5 year) survival, mortality rates in newborns (those 28 days or younger) has barely improved since the 1990s due to susceptibility of the developing immune system coupled with sub-optimal immunization. Current vaccination schedules leave newborns vulnerable and maternal immunization doesn't protect preterm or low birth-weight newborns. Growing public vaccine resistance and hesitancy exacerbate the challenge of delivering vaccines in early life. Optimizing and tailoring use of currently available BCG vaccines to newborns, including administration at birth, could dramatically improve protection against infection. Live attenuated (weakened) BCG vaccines induce broad protection against a range of microbes (unrelated to tuberculosis) but different BCG formulations are produced across the globe, are used interchangeably and given across the first weeks of life. Diverse BCG vaccines induce very different immune responses that are most effective when given at birth. There is urgent need to optimize use of BCG vaccine in newborns and raise awareness of immunization benefits. Change can be realized via demonstrating the most effective BCG vaccine approach and scaling the solution to inform new recommendations and policies. Targeting infants provides great leverage as protection can have lifelong benefits. Maximizing precision vaccine benefit to infants coupled with sophisticated media campaigns targeted to countries with high infant mortality and areas of vaccine resistance will increase vaccine uptake and further reduce infection.

Solution Overview

Our solution is an innovative approach to ensuring that newborns and infants, through immunization, are given the best chance of surviving childhood infectious diseases. We will tackle the problem of early life infection by: (a) leveraging newly appreciated beneficial effects of BCG vaccines, which enhance neonatal immune development and induce broad protection against a range of infectious diseases [1-6], by identifying and then scaling the most effective timing (e.g., administering at birth versus at several weeks of age) and formulation of BCG vaccine; and (b) capitalizing on the beneficial impact of vaccine optimization by targeted public media campaigns highlighting the value of early life immunization in resource-poor and -rich settings. We will track progress by observing lower infant mortality (at least 30% reduction [2, 10]) and morbidity in those receiving optimal BCG formulation at birth in Phase 1, an effect that will be amplified by scaling in Phases 2 and 3. By project Year 5, our optimized BCG solution will inform revision of WHO recommendations on BCG formulation usage and Global Alliance for Vaccines and Immunization (GAVI) policies to prioritize immunization at birth, resulting in global optimization of BCG use. This will directly benefit the ~100 million infants who receive BCG each year, reducing healthcare costs and increasing productivity, a broad and deep impact on humanity. At a time that vaccines are increasingly under attack, we will implement a new paradigm in vaccinology and disseminate powerful public health messages, thereby increasing vaccine confidence around the world with consequent global benefits.

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