Maternal immunization country readiness: a checklist approach

Figures & data

Table 1. Maternal immunization readiness checklist

Question	Indicator	Definition	Rationale	Yes	Yes but needs strengthening prior to introduction	No
Is there an existing national policy on maternal tetanus immunization?	Policy	N/A	An existing policy on maternal tetanus immunization provides the foundation upon which new maternal vaccines can be integrated
Is there a national policy on number and content of ANC visits?	Policy	N/A	A policy on the number and content of ANC visits helps to adapt messaging from HWs to ensure that pregnant women attend the minimum recommended number of visits at the recommended times during pregnancy to conduct appropriate tests and interventions
Is there a functioning NITAG?	Governance	The minimal set of indicators agreed to by WHO to allow for monitoring of functionality at a global level: legislative or administrative basis for the advisory group; written terms of reference; at least five different areas of expertise among members; at least one meeting per year; circulation of the agenda and background documents at least one week prior to meetings; mandatory disclosure of any conflict of interest	A functional NITAG is a formally constituted national technical advisory body, responsible for providing independent, evidence-informed advice to health authorities. The main role of NITAGs is to collect, review, assess and organize scientific evidence on vaccine-related topics in the form of recommendations to national health authorities, that take into account the local epidemiologic and social context which is essential when considering introduction of an additional or new maternal vaccine
If there is a NITAG, is there a MNCH expert on the NITAG?	Governance	N/A	When considering maternal vaccination, particularly if implementation is to be via ANC services, then consultation with experts on maternal and newborn health and ANC service delivery is essential to ensure factors unique to the antenatal context are considered and addressed to minimize barriers and maximize smooth introduction
If there is no MNCH expert on the NITAG is there engagement with the relevant expert group(s)?	Governance	Examples may include MNCH, Professional Obstetric or Pediatric organizations	See above
Do you give any maternal vaccines in addition to TT/Td (e.g. Influenza, Pertussis, Yellow Fever, Meningococcal A)?	Recent experience introducing additional maternal vaccines	N/A	Experience in introducing an additional maternal vaccine to existing maternal tetanus programs may mean that relevant mechanisms, e.g., committees, HW training, communication strategies etc in the ANC setting have been developed and strengthened
Have you introduced any new vaccine(s) in the NIP in the previous 5 years?	Recent experience introducing new vaccines	N/A	Recent experience introducing a new vaccine may mean that relevant mechanisms, e.g., committees, HW training programs, communication strategies etc. have been developed and strengthened in the NIP in addition to strengthening surveillance systems and monitoring and evaluation processes		Not Applicable
Is the NIP able to mobilize and use sufficient resources for the existing program and its expansion without threatening financial sustainability of domestic funding?	Financing	N/A	Short and long-term funding needs to be clearly defined prior to the introduction of a new maternal vaccine to ensure readiness for implementation
Is the PAB >90%?	Existing Tetanus Program	Proportion of babies protected from tetanus at birth	PAB can be used to estimate performance of the existing maternal tetanus immunization program.
Does TT2+ coverage meet targets defined in the National Policy or WHO-recommended coverage targets?	Existing Tetanus Program	Proportion of pregnant women receiving at least two doses of Tetanus toxoid containing vaccine	TT2+ coverage can be used to estimate performance of the existing maternal tetanus immunization program.
Does DTP3 coverage meet targets (per age group) defined in the National Immunization Policy?	Existing Immunization Program	Third dose diphtheria-tetanus-pertussis immunization in children	Defined targets for routine vaccines (as stated in local policies and guidelines) and experience in reaching hard-to-reach areas or communities based on coverage targets are strong attributes when considering introduction of new maternal vaccines.
Does ANC4+ coverage meet targets as defined in the national antenatal care policy or internationally recommended coverage targets?	Existing Antenatal Care	Number of women having at least 4 ANC attendances, over all pregnant women.	Attending the minimum number of recommended antenatal contacts is important to maximize the opportunities for vaccination during pregnancy. As the number of recommended maternal vaccines increases and/or new vaccines come with specific recommendations for administration according to gestational window, the need for multiple ANC contacts across a number of trimesters becomes increasingly important.
Is a system in place to record the proportion of women who have at least one ANC visit in the 3^rd trimester?	Existing Antenatal Care	At least one ANC visit taking place after 28 weeks gestation.	New maternal vaccines may be recommended within a short vaccination time window during pregnancy therefore having a system in place to record when women are attending for ANC visits is beneficial
Is a system in place to record the proportion of women who have at least one ANC visit in the 2^nd trimester?	Existing Antenatal Care	At least one ANC visit taking place between 14 and 27 weeks gestation.	Having a system in place to document/record when women are attending ANC services is beneficial particularly if future vaccines are to be provided through ANC, and especially if recommended for specific gestational age windows.
Is a system in place to record ANC quality?	Existing Antenatal Care	No agreed definition	Although no agreed definition is yet established, consideration of not just the number of ANC visits but whether practitioners with good clinical and interpersonal skills are providing individualized, person-centered care at every antenatal contact, implementing evidence-based effective practices in a timely manner, and providing information and psycho-social and emotional support. If quality of ANC is poor and women’s experience is negative then evidence suggests that women will not attend ANC irrespective of the number of recommended visits.
Are there any ANC fees currently incurred by pregnant women?	Existing Antenatal Care	ANC fees may be for examination, appointments, ultrasound, laboratory tests etc.	Fees may be a disincentive to ANC attendance; therefore they are an important factor to consider.
Are program coordination, roles and responsibilities by NIP and ANC/MNCH clearly defined and understood?	Program co-ordination	Both NIP and ANC share joint responsibility for maternal immunization (although this may vary depending on local contexts).	Having clearly defined roles and responsibilities, as well as communication pathways between NIP and ANC are important to ensure functional integration of maternal immunization into the broader immunization program
Is a program in place for HW education and training in relation to maternal immunization?	Delivery platform	N/A	An adequately trained workforce (quality of staff) is important in the context of maternal immunization to be able to communicate with pregnant women, answer questions, safely administer vaccines and have the knowledge and experience to address any adverse events.
Is there an adequate number of HWs to deliver new maternal vaccines without compromising delivery of existing components of antenatal care?	Delivery platform	The actual number will depend on the level of service provision and can be defined by the country.	Adequate human resource capacity (number of staff) needs to be available to ensure demand is met and administration and delivery of the immunization program occurs safely
Is the vaccine procurement system robust and able to forecast demand for all existing and new vaccines?	Vaccine delivery system	N/A	A plan for procurement including national licensure processes, estimated target population size, forecasting the number of doses and injection supplies required per year is needed to ensure adequate and sustained vaccine supply.
Is the cold chain capacity adequate for existing vaccines and for the addition of a new vaccine?	Vaccine delivery system	N/A	Existing cold chain must demonstrate adequate capacity and performance to absorb the introduction of a new vaccine. This includes adequate cold storage space or plans to expand to meet future needs. Reliable storage and cold chain is vital to the quality and goals of the immunization program.
Is surveillance for maternal mortality and VPDs in place?	Surveillance	This system should track all maternal deaths in real time, help understand the contributing factors and stimulate and guide actions to prevent further deaths. The Maternal Death Surveillance and Response is a model of such a system.	A surveillance system to monitor maternal mortality and disease, (specifically related to maternal vaccines such as puerperal sepsis due to GBS, tetanus, influenza, pertussis, RSV) and epidemiological changes in disease burden can assist in assessing performance of the NIP and ANC and in identifying weaknesses or gaps.
Is surveillance for neonatal mortality and VPDs in place?	Surveillance	This system should capture the number of deaths and causes, and also have the capacity to identify specific cases for analysis with a view of response or action to be taken.	A surveillance system to monitor neonatal mortality and disease, (specifically related to maternal vaccines such as tetanus, influenza, pertussis, RSV, GBS) and epidemiological changes in disease burden can assist in assessing performance of the NIP and ANC and in identifying weaknesses or gaps.
Is stillbirth surveillance in place?	Surveillance	WHO definition for stillbirth: 1000 g or 28 weeks and above. Many countries use 500 g and 24 weeks and above.	A surveillance system to monitor stillbirths, which may include timing, weight and cause and epidemiological changes in disease burden can be used to assist in assessing performance of the NIP and ANC and in identifying weaknesses or gaps
Is an AEFI reporting system in place?	Surveillance	N/A	A system to monitor AEFI is essential to capture AEFI that may only become apparent once the vaccine is used on a large scale. It also enables countries to be able to deal promptly with severe AEFI to ensure that public confidence in the NIP and ANC services is maintained.
Does the AEFI reporting have the capacity to identify pregnant women?	Surveillance	N/A	A system with the capacity to identify pregnant women is essential to facilitate any early detection of a safety signal within the target population and to ensure public confidence in the NIP and ANC service
Is a health information system (including maternal vaccination) in place? If there is a health information system in place, does it capture maternal vaccination by private providers?	Monitoring and evaluation	N/A	A health information system that is able to use existing antenatal records can assist facilities in recording and reporting maternal immunization coverage (and thereby reportable targets). Recording ANC services and vaccination provided by the private sector should be considered depending on the country context (e.g., how much ANC is accessed through the private system). This will help ensure accurate coverage data particularly in settings where private providers cover considerable proportions of the population
Is there evidence of vaccine hesitancy among your pregnant population?	Vaccine hesitancy	Vaccine hesitancy refers to delay in acceptance or refusal of vaccination despite availability of vaccine services	High levels of vaccine hesitancy may lead to low vaccine demand.
Are demand creation activities for maternal immunization such as a communication strategy planned and/or in place?	Demand Creation/Communication	Demand creation is the process of increasing the demand for a product or service	Working with communities to achieve high levels of maternal immunization acceptance may help reduce barriers to vaccine introduction. Communication strategies to educate pregnant women, health staff and communities about the benefits of vaccinating pregnant women and to respond to potential concerns about the efficacy and safety of the vaccine are necessary to raise awareness, mitigate against vaccine hesitancy and create demand.

Table 2. Abbreviations used in Table 1

N/A- not applicable

HW- health workers

NIP- National Immunization Programme

TT- Tetanus toxoid containing vaccine

Td- Tetanus and diphtheria containing vaccine

PAB- protection at birth

ANC- antenatal care

MNCH- maternal neonatal child health

VPD- vaccine preventable disease

NITAG- National immunization technical advisory group

TT2-+ the proportion of pregnant women receiving at least two doses of Tetanus toxoid containing vaccine

DTP3- third dose diphtheria-tetanus-pertussis immunization in children

ANC4+- antenatal care visits (four or more)

AEFI- adverse event following immunization