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. Author manuscript; available in PMC: 2019 Oct 1.
Published in final edited form as: Vaccine. 2019 May 6;37(25):3267–3277. doi: 10.1016/j.vaccine.2019.04.075

Table 2.

Factors to consider for the introduction of new vaccines for pregnant women and the programmatic challenges for LMIC.

Factors to consider for the introduction of new vaccines for pregnant women Programmatic challenges for LMC
  • Defining the target populations for the new vaccine at different levels of the health system (national, regional, and local levels)

  • Epidemiological surveillance (sentinel surveillance for high incidence diseases, and national surveillance for lower incidence diseases is recommended)

  • Planning for the financing of the vaccine introduction

  • Establishing vaccination strategies

  • Adequate procurement mechanisms for the vaccine

  • Standardization of vaccine delivery through modifications of the national vaccination schedule and establishment of standard operating procedures for new vaccine introduction

  • Well-functioning cold chain, waste disposal and supply chain integrated into the national immunization program’s existing systems

  • Coordination among the stakeholders and regional platforms for immunisation in pregnancy (e.g. vaccine manufacturers, national regulatory bodies, ethics committees, NITAGs, pharmacovigilance programs, maternal and child health and immunization programs, funders, healthcare workers, scientific communities, professional societies, non-governmental organisations (NGOs), religious and community leaders, pregnant women, and the media)

  • Consistent tools, documents (forms, reports) and information technology platforms across different programs and services

  • Monitoring, supervision, and evaluation for the program

  • Absence of background data on disease burden and maternal and neonatal outcomes

    Difficulties in determining the denominators for vaccination coverage

  • Lack of epidemiological surveillance for diseases

  • Limited resources for introduction of new vaccines and strengthening the routine immunisation programs

  • Lack of programmatically suitable vaccines to be used in low-resource settings

  • Gaps in vaccine availability

  • Insufficient doses of vaccines to cover all pregnant women

  • Poor logistics for vaccine acquisition, storage, administration, and tracking

  • Lack of integrated approaches among stakeholders and the different programs

  • Lack of promotion of maternal immunization policies by health authorities

  • Lack of sufficient numbers of trained healthcare workers

  • Incorrect beliefs regarding immunization found in pregnant women, communities and healthcare workers (e.g. pregnant women not perceived to be at increased risk for disease, do not believe that vaccination is a necessary preventative health measure, conspiracy theory thinking, eschewing medical providers in favor of “complementary” or “alternative” medical practices during pregnancy, concerns about safety of vaccines for pregnant women, fetuses and infants)

  • Lack of reporting and causality assessment of adverse events

  • Ineffective communication of the risks by health care workers

Training for stakeholders
  • Communication plans for the public and key stakeholders

  • Pharmacovigilance plans

  • Crisis plans for thorough and timely response to adverse events and communication to the public and media