TABLE 2.

Key messages from stakeholders^a

Stakeholder	Main obstacles	Potential solutions
Investigators	Lack of baseline data for maternal and neonatal outcomes	Partnering with local care providers and the community, including women who have received vaccines in pregnancy as advocates for the program/study.
	Retention of pregnant women in clinical trials	Increase public acceptance and confidence through information.
	Impact of coinfections and adverse event reporting	Conduct multidisciplinary research which includes pregnant women and their communities.
Obstetric antenatal care providers	Acceptance and logistics of vaccination during pregnancy in LMIC	In some cases, the preferred time to give the vaccines is outside pregnancy, in adolescence, as part of a preconception package.
		Communication with the pregnant women needs to be “right the first time.”
		Harmonize standards for conduct of clinical trials and data collection systems so that not every country will wish to repeat the studies and results are acceptable across countries.
Regulatory perspective	Logistics of research and managing perceptions and expectations	The clinical development of novel vaccines requires frequent interactions with the Regulator, including DSMB and ethics input.
		Ethics committees need to be strengthened and need to include adequate multidisciplinary and regional representation of relevant experts. They may benefit from educational efforts on maternal immunization, especially on new data, experiences, and regulations from other maternal vaccine development programs.
		When a double-blind, placebo-controlled trial is not possible, do not refrain from doing studies altogether.
Academics	Support for research	Funding is needed for basic science but also for collection of baseline epidemiological data, which are hard to come by.
		Collaborations need to occur between all stakeholders.
		Postimplementation studies: effectiveness, coverage studies.
Policy	Challenges identified in different domains
Biological issues	Timing of vaccination during pregnancy	Time of vaccination will determine titers of protective antibody at the time of delivery—encourage early registration to optimize the window.
	Impact on vaccination schedules	Impact of novel vaccines on any existing vaccines already in the schedule needs to be clarified, to inform scheduling and safety data.
Health systems issues	Logistics of antenatal care and EPI	Maternal vaccination is a golden opportunity to bring ANC and EPI together.
		The knowledge of front-line health care workers administering vaccines needs to improve through appropriate training.
		An investment case needs to be made, as policy relates to costs.
Sociocultural issues	Optimizing sharing of knowledge and implementation	Early pregnancy remains secretive in LMIC.
		Inform SAGE and prepare appropriate follow-up studies and have policy impact.
		Communication is key to educate on risk/benefit considerations and merits of vaccines. Uncertainties ought to be discussed, and risk/benefit considerations should be in the public domain through informed sources.
Industry	Collaborations	Industry needed to guarantee sustained supply of vaccines.
	Safety	Trust is required in provider, product, and policy.
		Licensing of products in pregnancy can remain a problem for industry.
		Safety monitoring of vaccines is continuous; safety data from special populations need to be enhanced (e.g., label updates).
Funders	Priorities and commitment	There is continued funder commitment, and there have been significant achievements.
		The maternal immunization platform has high potential for addressing neonatal deaths, preterm births, and stillbirths; all are the focus of funder activities.
		The maternal immunization platform is a potential means to combat antimicrobial resistance.
		Maternal immunization is a concept for cross-sectional learning between the vaccine and the maternal/neonatal health communities.
		Assay standardization commitments will inform label extensions.
		Maternal immunization fits well into the lifetime vaccination approach taken by PAHO and SAGE.
		The maternal immunization platform can serve a number of purposes toward improving maternal and infant health.
		Conducting basic science projects relating to maternal/fetal physiology/immunology.

^aParticipants included Mustapha Bittaye (ANC provider, MRC Unit, The Gambia), Sonali Kochhar (Researcher, Global Healthcare Consulting), Kirsty LeDoare (Academic Scientist, Imperial College London), Pieter Neels (Regulatory, Vaccine-Advice BVBA), Martin Ota (Policy Expert, WHO Africa Regional Office), Ajoke Sobanjo ter-Meulen (Funder, Bill and Melinda Gates Foundation), and Ivo Vojtek (Industry, GSK Vaccines). The session was chaired by Beate Kampmann (Researcher, Imperial College London and MRC Unit, The Gambia). Abbreviations: SAGE, Strategic Advisory Group of Experts; INMIS, International Neonatal and Maternal Immunization Symposium; LMIC, low- and middle-income countries; EPI, Expanded Program on Immunization; NIH, National Institutes of Health.