A Roadmap for Advancing RSV Maternal Immunization

From Advancing Maternal Immunization (AMI), a collaboration coordinated by PATH and the World Health Organization (WHO), this resource outlines the activities needed to inform decision-making around how to bring maternal respiratory syncytial virus (RSV) vaccines from the development phase to routine use in low- and middle-income countries (LMICs). RSV can cause severe complications such as pneumonia and bronchiolitis and is responsible for 1.4 million hospitalisations in the first year of life and 120,000 deaths before 5 years of age worldwide each year. Created with expert input from over 60 individuals across 25 organisations in 14 countries, the report stresses the importance of strong collaboration across immunisation and maternal, newborn, and child health communities in enabling informed decision-making about and introduction of, maternal RSV vaccines, particularly in LMICs.

AMI explains that the road ahead for advancing RSV maternal immunisation (MI) requires venturing into largely uncharted territory and depends on information yet to come. Though MI is available in some countries, delivery challenges and information gaps prevent it from being widely used in LMICs beyond tetanus prevention. Moving forward may not be as easy as applying the tetanus strategy to every new maternal vaccine, either; system adaptations will likely be necessary to routinely deliver RSV and other maternal vaccines in resource-limited settings.

This roadmap highlights activities that address critical gaps in essential evidence and conditions previously identified through AMI's July 2018 Advancing RSV Maternal Immunization: A Gap Analysis Report [PDF]. Some of the communication-related findings there:

• Stakeholder engagement using evidence- and value-based advocacy and communications (A&C) strategies will play a major role in awareness, perceptions, and acceptability around RSV and MI and generating vaccine demand. This will entail comprehensive stakeholder mapping, localised A&C strategies, and an understanding of baseline knowledge, awareness, perceptions, and acceptability.
• Relatedly, concerted effort will be required to improve knowledge and awareness of RSV disease and protection strategies, including MI, among healthcare workers, pregnant women, and their key influencers. Appropriate strategies for communicating information to generate demand will also require understanding community and provider perceptions to tailor information appropriately to local contexts.
• A strong evidence base around safety would also pre-emptively address potential risk perception, management of risk communication, and vaccine hesitancy issues. From an ethics perspective, MI gives a mother an opportunity to protect her child - and in some cases, herself - a frame potentially important for advocacy and demand generation. However, there is a need to move from a risk-based approach to one where the interests of expectant mothers assume centrality.
• RSV delivery provides an opportunity to educate mothers and reinforce vaccine messaging throughout the life course.

Figure 3 of the roadmap illustrates how the results of near-term activities identified in subsequent sections of the document connect with objectives that need to be achieved to advance RSV MI decision-making, introduction, and wide-scale use in LMICs. The most urgent activities identified in the roadmap centre on: supporting vaccine development and licensure; assessing RSV MI's potential health impact and return on investment to inform policy and financing decisions; developing communication strategies to support awareness and uptake; and ensuring countries are equipped to deliver the vaccine routinely, efficiently, and equitably once it is available. Examples include:

• Conduct formative research to inform optimal vaccine delivery approaches: Sub-activities to begin in 2019: (i) gain key stakeholder consensus on criteria for identifying countries to conduct formative research and possible demonstration projects; (ii) conduct knowledge, awareness, and perception studies in-country around RSV disease, RSV prevention, MI acceptability, demand for MI and vaccination during antenatal care (ANC) delivery, and RSV vaccine's perceived priority level; and (iii) conduct feasibility studies that evaluate country-level MI drivers and barriers and account for current practices, different delivery channels, and immunisation and maternal, neonatal, and child health (MNCH) programme responsibilities from system, provider, community, and beneficiary perspectives.
• Assess A&C needs and develop strategies to raise awareness, communicate value, and support informed RSV MI decision-making: Work will identify key audiences and optimal ways to raise awareness and communicate with them. It will equip global, regional, national, and sub-national champions and advocates with appropriate tools and strategies to communicate effectively about RSV, MI, and RSV prevention measures as appropriate, support informed decision-making, and assist planning for vaccine introduction and scale-up. A&C planning will also account for potential communications crises and opposition factors affecting RSV MI. Appropriate and effective stakeholder engagement needs to happen, and A&C needs and strategies will require multiple assessments and continual refinement to address different contexts and evolving needs.

Overall, AMI states, the near-term activities outlined in this roadmap are urgently needed for RSV MI decision-making and LMIC delivery to move forward. For example, they will support increased awareness of RSV and MI, which is important given observations of low RSV awareness and prioritisation, particularly at the country level. These activites are also imperative to ensuring that countries optimise vaccine use once maternal RSV vaccines are available. The next step towards informed maternal RSV vaccine decision-making and rapid and efficient introduction and uptake in LMICs is to identify responsible parties for ensuring that specific pieces of this work are conducted in the timeframe needed, that efforts are coordinated, and that results are communicated with appropriate stakeholders.

Click here for the 73-page gap analysis (companion) report in PDF format.