Immunizing in pregnancy to protect the fetus, neonate and mother: Bridging the gap between vaccine evidence and adoption in low income countries Open Access

Abstract

Neonatal mortality as a share of under-5 mortality is substantial. Preterm birth, intrapartum complications and infectious diseases are the leading causes of neonatal deaths worldwide. In 2012, the neonatal mortality rate in low income countries was more than 8 times that of high income countries, signaling the need for more intensive efforts to ensure survival early in life in low income countries. Immunizing in pregnancy has the potential to avert millions of cases of disease, disability and death in mothers and neonates, and ensure good pregnancy outcomes.

Current evidence suggests that routine use of the following ten vaccines in pregnancy can have a substantial impact on the infectious disease burden in low income countries: Tdap (tetanus-diphtheria-acellular pertussis)/tetanus toxoid vaccine; inactivated influenza vaccine; Haemophilus influenzae type B vaccine; pneumococcal vaccine; meningococcal vaccine; hepatitis B vaccine; hepatitis E vaccine; group B streptococcal vaccine; respiratory syncytial virus vaccine; and malaria vaccine. There is variability in the availability of these vaccines, with some still in the development pipeline. Challenges that may impede routine use of these vaccines in pregnancy exist, the foremost of which is insufficient definitive evidence on their effectiveness on clinical outcomes.

There is global support and advocacy for immunizing women in pregnancy. However, there are also barriers to adoption by lower income countries. To bridge the gap between evidence and adoption, a strengthening of the evidence base has to occur; there has to be clear recommendations for routine use of these vaccines in pregnancy by WHO; the vaccine adoption decision-making processes in many low income countries has to be strengthened; and private-public partnerships that address acceptability issues related to multiple vaccine administration in pregnancy are required. Accomplishing these objectives will pave the way to adoption and eventually lead to a decrease of the global neonatal disease burden.

Table of Contents

PART I. Introduction....................................................................................................... 1

1.1. Overview................................................................................................................ 1

1.2. Background on neonatal mortality.............................................................................. 2

1.3. Addressing neonatal mortality through maternal immunization....................................... 5

1.3.1. Quadruple benefit of maternal immunization............................................................. 6

1.4. The immune system: Pregnant mother, materno-fetal environment and the neonate......... 7

PART II. Vaccines: Evidence of protection.......................................................................... 12

2.1. Tdap (Tetanus-diphtheria-acellular pertussis) vaccine / TT (tetanus toxoid) vaccine.......... 12

2.2. Inactivated influenza vaccine (IIV)............................................................................. 17

2.3. Haemophilus influenzae type B vaccine....................................................................... 24

2.4. Pneumococcal vaccine.............................................................................................. 27

2.5. Meningococcal vaccine............................................................................................. 29

2.6. Hepatitis B vaccine.................................................................................................. 32

2.7. Hepatitis E vaccine.................................................................................................. 34

2.8. Group B streptococcal vaccine.................................................................................. 37

2.9. Respiratory syncytial virus vaccine............................................................................ 40

2.10. Malaria vaccine..................................................................................................... 42

PART III. Immunizing women during pregnancy: Timing and mode of delivery....................... 45

3.1. Timing of immunization........................................................................................... 45

3.2. Antenatal care as a point of access............................................................................ 45

Case study. Maternal and neonatal tetanus elimination initiative.......................................... 47

PART IV. Policy environment and global support for maternal vaccine introduction

in low income countries.................................................................................................. 48

4.1. Policy environment.................................................................................................. 48

4.2. Global support and advocacy.................................................................................... 49

Part V. The road to adoption: key considerations................................................................ 53

5.1. Burden of disease.................................................................................................... 53

5.2. Broad evidence of vaccine impact.............................................................................. 53

5.3. Health system infrastructure..................................................................................... 54

5.3.1. Maternal vaccine delivery strategy.......................................................................... 55

5.3.2. Vaccine system management................................................................................. 55

5.4. Demand & supply.................................................................................................... 56

5.5. Cost...................................................................................................................... 56

5.6. Ethical and vaccine acceptability issues...................................................................... 58

5.7. Decision-making process.......................................................................................... 58

5.7.1. Political leadership................................................................................................ 59

5.7.2. Public health staff................................................................................................. 59

5.7.3. Advocacy groups.................................................................................................. 59

5.7.4. National advisory bodies........................................................................................ 60

5.7.5. National Regulatory Authority................................................................................. 60

5.7.6. External groups.................................................................................................... 60

5.7.7. The process......................................................................................................... 61

6. Proposed roadmap for adoption.................................................................................... 61

Conclusion.................................................................................................................... 64

References.................................................................................................................... 65

About this Master's Thesis

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School	Rollins School of Public Health
Department	Career Masters of Public Health
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Immunology Health Sciences, Epidemiology
Keyword	Tdap Meningococcal Adoption Low birth weight Group B streptococcus Malaria Pregnant women Neonatal mortality Preterm Hib Pneumococcal Influenza Hepatitis E Tetanus toxoid Hepatitis B Maternal immunization Pregnancy Vaccine RSV
Committee Chair / Thesis Advisor	Omer, Saad B, Emory University
Committee Members	Bednarczyk, Robert A, Emory University
Partnering Agencies	Does not apply (no collaborating organization)

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