GAIA: Global Alignment of Immunisation safety Assessment in pregnancy

Executive Summary


Reducing neonatal and thus under-five mortality and morbidity is a millennium development goal. Immunization in pregnancy is a promising approach to achieving this goal. It prevents infectious diseases and its complications by direct protection of the mothers as well as by indirect protection of the neonate by intrauterine antibody transfer from mother to child. Vaccines are available to prevent tetanus, influenza and pertussis during pregnancy and early life. They are now being systematically evaluated and increasingly recommended for global introduction as part of a maternal immunization platform. Promising vaccines are in development for global use and include group B streptococcal (GBS) and respiratory syncytial virus (RSV) vaccines.

Introduction of these vaccines comes with tremendous potential benefit specifically for LMIC. However, there is much at stake when it comes to immunization of pregnant women. The safety of any product given to these primarily healthy mothers and their unborn babies is under specific professional and public scrutiny and safety concerns related to immunization in pregnancy are unlikely to affect these programs alone. Particularly when the vaccines are also used in routine childhood and adult immunization programs, such as influenza and pertussis vaccines. Therefore, real product or program specific safety issues need to be identified to appropriately assess the benefit-risk profile of these vaccines and their programs and to protect the target population from unintended harm. On the other hand, unfounded public or professional concerns can jeopardize beneficial vaccine programs and need to be rapidly refuted based on rigorous science and globally well-coordinated decision making and communication.

The need for a globally concerted approach to actively monitor the safety of vaccines and immunization programs is recognized by the WHO Global Vaccine Safety Blueprint, the strategic plan of the Global Vaccine Safety Initiative. A recent WHO consultation identified the currently fragmented research, the current lack of data comparability as well as the need to improve the quality of safety data to inform decision making and system strengthening.



In an era of successful global immunization programs, high quality and globally concerted data collection, analysis and communication are paramount. Comparability of safety data across products, programs, and populations is a pivotal aim for effective and efficient strengthening of immunization programs in pregnant women. As a first step, GAIA (Global Alignment of Immunization safety Assessment in pregnancy) will provide standards and tools to establish a globally shared understanding of outcomes and approaches to monitoring them with specific focus on LMIC needs and requirements.

We propose to leverage existing methods and infrastructures developed by the GAIA consortium. For example, the Brighton Collaboration (BC) method to developing globally standardized case definitions is characterized by a structured approach of bringing together all relevant stakeholder groups including public health institutes, regulatory authorities, academic and patient care organizations as well as manufacturers to gather available evidence and build consensus on standards for global use with specific awareness of LMIC needs. Based on this experience, the GAIA consortium will develop a core set of globally standardized case definitions of key outcomes, and also create case identification algorithms and data collection tools for monitoring immunization programs in pregnancy. We also develop guidance for harmonized data collection, analysis and presentation of these events. Through a stringent public consultation process including partners from LMIC and close interaction with investigators of ongoing trials and parallel projects operational in LMIC we will evaluate the usefulness and practicability of the draft outputs prior to recommendation for wider implementation.



Investing in a globally concerted approach will give added value to the individual studies/investments and strengthen a multinational platform for immunization in pregnancy. Harmonized outcome assessment is a critical element of a wider global active safety monitoring infrastructure, which will ultimately allow rapid evaluation and response to safety signals or concerns. The first step of optimizing data comparability will result in case definitions, guidance, and tools for immediate use by investigators, trialists and vaccine program officers globally with a specific focus on LMIC.


Charitable purpose of this work

To improve data generated for strengthening programs of immunization in pregnancy by harmonizing maternal, pregnancy, fetal, and neonatal health outcome assessment with specific focus on Low and Middle Income Countries (LMIC).


This project is sponsored by a grant of the Bill & Melinda Gates Foundation.