Use of controlled temperature chain and compact prefilled auto-disable devices to reach 2030 hepatitis B birth dose vaccination targets in LMICs: a modelling and cost-optimisation study

Abstract

Background Hepatitis B causes more than 800 000 deaths globally each year. Perinatal infections are a major driver of this burden but can be prevented by vaccination within 24 h of birth. Currently, only 44% of newborn babies in lowincome and middle-income countries (LMICs) receive a timely birth dose. We investigated the effects and costeffectiveness of implementing ambient storage of hepatitis B vaccines under a controlled temperature chain (CTC) protocol and the use of compact prefilled auto-disable (CPAD) devices for community births. Methods In this mathematical modelling study of perinatal hepatitis B transmission and disease progression, we estimated the coverage impact and cost-effectiveness of implementing CTC and CPAD interventions in the sixGlobal Burden of Disease (GBD) regions containing LMICs. Combinations of four different scenarios of birth dose delivery strategies (cold chain, CTC) and interventions (needle and syringe, CPAD) were modelled across facility or community birth locations. We also estimated the minimum cost and most cost-effective strategy to achieve the WHO 90% hepatitis B birth dose coverage target in GBD regions and in 46 LMICs with a reported coverage of less than 90%. Findings Current delivery protocols achieved a maximum coverage of 65% (IQR 64-65) across GBD regions. Reaching 90% hepatitis B birth dose coverage across all GBD regions was estimated to cost a minimum of US$687•5 million per annum ($494•0 million more than the estimated current expenditure), of which $516•5 million (75%) was required for CTC and CPAD interventions. Reaching 90% coverage in this way was estimated to be cost saving in five of the six regions (and in 40 of 46 LMICs individually assessed) due to the disease costs averted, with the cost per disability-adjusted life-years averted being less than $83•27 otherwise. Interpretation Hepatitis B birth dose coverage of 90% is unlikely to be reached under current protocols. CTC and CPAD vaccine strategies present cost-effective solutions to overcome coverage barriers. Funding The Burnet Institute.

Análisis económico de las vacunas del primer año de vida con componente pertussis en el contexto de la ini-ciativa mundial de erradicación de la poliomielitis en Argentina

“…Por otro lado, también hemos podido observar que se reducen los costos del programa en lo que tiene que ver con almacenamiento y distribución de vacunas en cadena de frío, siendo el ahorro de tres dosis de hexavalente de USD 28.764 comparado con el escenario base y de ~USD 42.000 en comparación con el esquema actual. La problemática de los costos de distribución de vacunas en cadena de frío ya se ha identificado previamente 12,13 . Nosotros hemos encontrado que el esquema actual, con la incorporación de IPV incrementa el costo del programa en cadena de frío, distribución y recursos en salud (USD 13.212) al igual que lo describe un estudio desarrollado en Brasil por Sartori y cols.…”

The Costs of Introducing the Hepatitis B Birth Dose Vaccine into the National Immunization Programme in Senegal (NéoVac Study)

“…Accordingly, even if all infants born in healthcare facilities were to receive the HepB-BD according to the WHO recommendation, achieving the target of 80% HepB-BD coverage by 2030 would be difficult [ 3 ]. Additional strategies to reach babies not born in healthcare facilities are urgently needed in Sub-Saharan Africa, including the systematic notification of home births to EPI staff by lay community workers [ 25 ], increased home-based outreach vaccination using mono-dose vaccines (either in vials or in pre-filled auto-disable injection devices (cPAD)) [ 26 , 27 ], and ambient storage of HepB-BD under a controlled temperature chain [ 27 ].…”

Implications of Birth-Dose Vaccination against Hepatitis B Virus in Southeast Asia

“…This is widely supported by policymakers, politicians, public health workers, doctors, and pregnant mothers, and a system is in place enabling most infants to receive the pentavalent vaccine. However, several types of preparations are required for the implementation of birth-dose vaccination [13][14][15]. In SEARO countries, the attitude of the mothers and policy makers to birth-diose hepatitis B vaccination program should be properly assessed and realized.…”

“…However, proper assessments were not accomplished in some of these countries regarding the overall target of containment of HBV in these countries. Implementation of HepB-BD requires some specific facilities [13][14][15]. These include hospital delivery, abundant supply of vaccine at the periphery, and proper staff to administer the vaccines.…”