KEMRI, Partners chart next phase of Maternal Vaccine Safety Surveillance

BY STELLA NJUNG’E

Efforts to strengthen the safety monitoring of vaccines administered to pregnant women are entering a new phase, as the Kenya Medical Research Institute (KEMRI) and its partners move to establish sustainable surveillance systems in Kenya and Ghana.

The next phase of the Maternal Immunization Safety Surveillance Program (MISS-P) took centre stage during a three-day annual working meeting held in Malindi from 14th to 16th October 2026. Regulators, researchers, health officials and digital health partners convened to review lessons from pre-testing and agree on priorities for the programme’s three-year Phase II implementation.

The discussions focused on integrating maternal vaccine safety surveillance into existing health information and regulatory systems, improving access to routine health data, strengthening collaboration between the two countries and establishing mechanisms to detect, assess and report potential vaccine safety signals.

A central concern was how to build a reliable surveillance system that fits seamlessly into routine clinical practice without placing additional demands on frontline health workers.

“Maternity units are busy places, and outcomes such as preterm birth are more common than many people realise. Seeing how data move from the antenatal clinic to the delivery room shows what a safety surveillance system must look like to work in routine care, and how it can support health workers rather than add to their load,” said study Co-Investigator from Aga Khan University, Prof. Angela Koech.

Partners examined how routine health records could be accessed and used responsibly, including clarifying data ownership, consent requirements and procedures for researchers seeking access to patient records. They also explored ways to link pregnancy databases with electronic medical records and existing adverse event reporting systems to support continuous monitoring of maternal and newborn health outcomes.

Technical discussions further focused on harmonising data between Kenya and Ghana, improving data quality and establishing reliable links between mothers’ records and those of their babies. These connections are essential for tracking health outcomes from pregnancy through delivery and after birth, providing a stronger evidence base for assessing potential vaccine safety concerns.

Participants also reviewed procedures for validating, managing and reporting potential safety signals, including coordination with the African Medicines Agency (AMA). The discussions examined how surveillance findings could be analysed and translated into evidence to inform regulatory decisions.

Dr. Martha Mandale of the Pharmacy and Poisons Board (PPB) underscored the value of active surveillance in complementing existing vaccine safety monitoring mechanisms.

“Active surveillance gives us something that spontaneous reporting alone cannot: a clear picture of what happens to mothers and babies over time. With this evidence, the Pharmacy and Poisons Board can assess safety signals quickly and make decisions grounded in data from our own population,” she said.

Beyond the technical requirements, the meeting addressed governance, institutional responsibilities and the long-term sustainability of the surveillance system. Participants received updates on complementary research, including studies to establish baseline rates of pregnancy and newborn outcomes, a planned pilot exploring the use of artificial intelligence with electronic medical records, and a social science study examining how pregnancy databases can be used and sustained.

The meeting brought together representatives of the Ministry of Health’s National Vaccines and Immunization Programme, the Digital Health Authority, Palladium, which supports the KenyaEMR system, and county health teams from Kilifi, Homa Bay and Kisumu. County representatives included health records, information and communications technology, and pharmacovigilance officers, alongside regulatory and research partners from Kenya and Ghana.

Dr. Rose Jalang’o, Head of the National Vaccines and Immunization Programme at the Ministry of Health, emphasised the importance of strengthening safety monitoring as maternal immunisation expands.

“Vaccines have transformed child survival in Kenya, and maternal vaccines are the next step in protecting our newborns. As these vaccines become increasingly available, the Ministry of Health is committed to working with regulators and researchers to monitor their safety closely and act quickly on any concern. That is how we keep the confidence of mothers and families,” she said.

A visit to Malindi Sub-County Hospital gave participants an opportunity to examine how electronic medical records are used in routine service delivery. They observed how information on mothers and their babies is captured and moves through the health system, from antenatal care to delivery.

The visit also offered regulators and researchers practical insights into the opportunities and challenges of implementing surveillance in a busy healthcare facility.

The meeting concluded with partners identifying priority actions, responsibilities and timelines for Phase II implementation. These commitments will guide the next stage of work towards a sustainable, country-led maternal vaccine safety surveillance system.

Through its leadership of Phase II in Kenya, working closely with the PPB and other partners, KEMRI is contributing to stronger systems for monitoring maternal vaccine safety and generating locally relevant evidence to inform regulatory decisions as new vaccines become available.