Center for Global Health

Hepatitis B Birth Dose Vaccination Activities in the African Region

Community of Practice for HepB Birth Dose Introduction in the African Region Meeting 1: The Current State of HepB Birth Dose Introduction Efforts

March 17–18, 2021

Rania A. Tohme, M.D., MPHTeam Lead- Hepatitis B and Tetanus

Global Immunization Division (GID), US CDC

GID Activities Related to Hepatitis B Vaccination Globally

▪ Estimate Hepatitis B burden and track progress towards achievement of regional goals

▪ Improve coverage with Timely HepB-BD

▪ Support HepB-BD Introduction

▪ Innovation and research (Global)

▪ Support Global and Regional Verification of control/elimination targets (WPR, EUR, AMR, SEAR, EMR)—verification not established in AFRO

1. Compiling evidence on hepatitis B virus infection prevalence in children and assessing risk of MTCT of HBV

Rationale▪ True burden of HBV infection post- pentavalent vaccine introduction is largely

unknown in children in African Region ▪ Unsubstantiated hypothesis that mother to child transmission (MTCT) of HBV is

lower in Africa than other regions due to different genotypes▪ Need data from Africa to provide evidence for HepB-BD introduction and inform

NITAGs

Main methods▪ Use pre-collected specimens from population-based HIV serosurveys to test for

HBV infection in children and women of reproductive age▪ Conduct mother-child paired serosurveys to estimate the risk of MTCT of HBV▪ Advocate for integration of hepatitis B testing in children in HIV surveys, DHS,

MICS, and other nationally representative surveys

Assessing the Impact of hepatitis B vaccination and the need for Hepatitis B Vaccine Birth Dose in Sierra Leone, 2018

Objectives

▪ Determine HBsAg prevalence in mothers, their 4-24 months old infants and 5–9-year-old children

▪ Assess importance of maternal HBV biomarkers as risk factors for perinatal transmission of HBV

Methods

▪ Multi-stage cluster household survey in Bo, Bombali and Western area urban

▪ Random selection by PPS of ~ 2000 women, 2000 infants and 2000 children

Key results▪ HBsAg prevalence:

• Women: 9.8% • Infants: 1.3%• Children: 1.6%

▪ Prevalence of HBsAg was 8 times higher in children born to HBsAg positive mothers than those born to HBsAg negative mothers (5.9% vs 0.7%)

▪ Maternal HBsAg, HBeAg and HBV DNA associated with infants’ HBV infection• >90% had detectable HBV DNA

Breakwell L, et al. Assessing the Impact of the Routine Childhood Hepatitis B Immunization and the Need for Hepatitis B Vaccine Birth Dose in Sierra Leone, 2018. ID week 2020, Abstract 1055. OFID 2020:7 (Suppl 1) • S557https://academic.oup.com/ofid/article/7/Supplement_1/S557/6057448

Assessing the Prevalence of HBV infection among children in Nigeria

Objectives▪ Estimate chronic HBV infection among children

<10 years old to assess vaccine impact and progress towards regional and global HepBtargets

▪ Validate use of dried blood spots (DBS) for testing hepatitis B surface antigen (HBsAg) and HBV DNA in serosurveys- ― implications for use and potential for better integration in future serosurveys

Methods▪ Testing specimens from Nigeria AIDS indicator

and impact survey• 7600 children aged <10 years stratified by

North/South and age group (<5 and 5-9 y.o)

Preliminary results/Not finalized ▪ HBsAg prevalence in children: 4.4%

Next steps▪ Finalize lab testing and analyze data▪ Test serum specimens from women

and validate with DBS

Local Partners▪ Nigeria Center for Disease Control▪ Nigeria Federal Ministry of Health▪ National Primary Healthcare

Development Agency (NPHCDA)

Determining the Risk of Hepatitis B Virus Mother-to-Child Transmission in Ghana

Objectives▪ Estimate the seroprevalence of HBsAg among pregnant

women presenting to antenatal care and their Infants aged 6-9 months

▪ Evaluate association between risk of HBV MTCT and maternal markers of infection (HBsAg, HBeAg, HBV DNA, and HBV genotype)

▪ Estimate the seroprevalence of chronic HBV infection among children aged 2-9 years old

Methods▪ Prospective cohort study▪ Screening 16,700 women attending ANC clinics and then

follow-up infants born to HBsAg positive women and equal number of HBsAg negative women for HBsAg testing

▪ Test another sibling aged 2 -9 years for HBsAg

Next steps▪ Obtain ethical approval

and Implement the project

Local Partners▪ Ghana Health Service

– Expanded program on Immunization

– National viral hepatitis control program

– National Public Health and Reference Laboratory

▪ Noguchi Memorial Institute for Medical Research

▪ African Field Epidemiology Network (AFENET)

2. Improve coverage with Timely HepB-BD

▪ Completed activities

– Supported WHO AFRO with development of HepB-BD post-introduction assessment Tools

– Participated in HepB-BD post-introduction assessments

• Botswana, Namibia, Nigeria, Mauritania, São Tomé and Príncipe(STP), Senegal

– Assessment of the cost-effectiveness of universal vs. selective HepB-BD for preventing chronic infections or HBV-related deaths in STP

• Provided key evidence that selective vaccination was not cost-effective and informed the need for universal HepB-BD

– Hagan JE, Carvalho E, Souza V, et al. Selective hepatitis B birth-dose vaccination in São Tomé and Príncipe: A program Assessment and cost-effectiveness study. Am J. Trop Med. Hyg. 2019; 10: 891-898

Improving Timely HepB-BD Coverage in Nigeria

Objectives▪ Assess whether implementation of a package of HepB-BD interventions

will lead to improved total and timely HepB-BD in Enugu and Kaduna States

▪ Package components– Training MCH and EPI staff about the importance of and methods for

delivering timely HepB-BD and implement regular supervisory visits– Educating pregnant women during ANC visits about importance of health

facility (HF) delivery, and HepB-BD administration – Training community health workers (CHW) to link pregnant women in the

community to HF for delivery and HepB-BD administration– Engage with community leaders and civil society to encourage HepB-BD

vaccination

Methods▪ Control LGAs and intervention LGAs (urban and rural)-14 HFs in each arm▪ Pre- and post-intervention assessment

– Pre- and post- intervention assessment of total and timely HepB-BD coverage in intervention and control LGAs

– Identify barriers and perspectives of healthcare providers related to the administration of timely hepatitis B birth

– Assess the impact of HepB-BD focused education on increasing HepB-BD knowledge, attitudes, and practices (KAP) among HCWs and pregnant women

– Assess the impact of CHW training on the importance of and methods for line listing and linkage of pregnant women and newborns to health facilities

Local Partners▪ National Emergency Routine Immunization Coordination Centre (NERICC)▪ Nigeria Stop Transmission of Polio (NSTOP) program ▪ African Field Epidemiology Network (AFENET)

Improving Timely HepB-BD Coverage in Nigeria

3. Support HepB-BD Introduction

▪ Completed Activities– Provide evidence for HepB-BD introduction

• Review paper on the Status of HepB control in African Region: Breakwell L, Tevi-Benissan C, Childs L, Mihigo R, Tohme RA. The Status of Hepatitis B Control in the African Region. The Pan African Medical Journal 2017; 27 (Supp3):17. doi:10.11604/pamj.supp.2017.27.3.11981

– Support countries in generating evidence needed by NITAGs for HepB-BD introduction (Uganda, Tanzania)

▪ Advocacy and support to build the platform for HepB-BD introduction in DRC in collaboration with WHO/AFRO

Ethiopia HepB-BD Pilot Introduction

▪ Support pilot HepB-BD introduction in selected woredas in Ethiopia to inform national scale up

▪ Ethiopia Federal Ministry of Health/MCH and EPI leading the implementation with support from US CDC and WHO

▪ Objectives– Identify challenges & barriers to HepB-BD vaccination

• Document lessons learned & best practices• Assess acceptance and feasibility of HepB-BD vaccination among

HCWs and mothers– Calculate timely HepB-BD coverage for HF and home births– Determine cost of introducing and maintaining HepB-BD– Assess impact of HepB-BD - HBsAg prevalence in children

What is Next?

▪ Continue to support countries with HepB-BD introduction, generation of evidence and implement key interventions to improve coverage

▪ Support WHO/AFRO in establishing a regional verification mechanism for hepatitis B control/elimination

▪ Evaluate use of HepB-BD outside the cold chain in the African context– Very successful strategy documented to improve timely HepB-BD coverage

among home births in Asia▪ Assess impact of HepB-BD in countries with good coverage (e.g. Namibia,

Senegal)▪ Advocate for more countries to introduce the Hepatitis B birth dose in Africa

– No child deserves to be born with HBV infection and later suffer as an adult from liver cancer—Hepatitis B is a vaccine preventable disease and hepatitis B vaccine is the first anti-cancer vaccine

Impact of Hepatitis B Vaccination on Disease Burden

Child L, Roesel S, Tohme RA. Vaccine 2018; 36: 6-14.

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For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.