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Clinical and regulatory development strategies for GBS vaccines intended for maternal immunisation in low- and
Kirsty Le Doare1, Virginia Benassi2, Marco Cavaleri3
1Immunizations, Vaccine and Biologicals, World Health Organisation, Geneva, Switzerland; Centre for Neonatal and Paediatric Infection & Vaccine Institute, City St George's, University of London, London, UK; Centre of Excellence in Maternal Immunisation, Makerere University Johns Hopkins University, Kampala, Uganda.
Insights
Group B Streptococcus (GBS) vaccines aim to reduce infant mortality. The World Health Organization (WHO) is exploring an alternate approval pathway using safety and immunogenicity data to speed access in low-income countries.
Area of Science:
- Immunology
- Vaccinology
- Global Health
Background:
- Group B Streptococcus (GBS) is a major cause of infant mortality, especially in low- and middle-income countries (LMICs).
- Maternal GBS vaccines are in clinical development to protect infants.
- Equitable vaccine access in LMICs is a key goal for the World Health Organization (WHO).
Purpose of the Study:
- To discuss the feasibility and challenges of an alternate vaccine approval pathway for GBS maternal vaccines in LMICs.
- To explore the use of safety and immunogenicity data (serological threshold of risk reduction - SToRR) as endpoints for vaccine approval.
- To reduce delays in vaccine availability and policy recommendations in high-burden LMICs.
Main Methods:
- The WHO organized consultative meetings at national, regional, and global levels.
- Discussions involved regulators, policymakers, and experts.
- Focus was on evidence supporting SToRR, inferring protection, and post-licensure requirements.
Main Results:
- The consultations addressed the novelty of using SToRR for regulatory approval in LMICs.
- Evidence supporting SToRR as a predictive immunological endpoint was reviewed.
- Potential challenges and post-licensure considerations were discussed.
Conclusions:
- An alternate approval pathway based on safety and immunogenicity (SToRR) is being considered for GBS maternal vaccines.
- This approach aims to expedite regulatory processes and improve vaccine access in LMICs.
- Further discussions and evidence are needed to implement this pathway effectively.
Abstract:
Group B Streptococcus (GBS) is a leading cause of infant mortality, particularly in low- and middle-income countries (LMICs). Several maternal GBS vaccine candidates, aimed at protecting infants, are progressing through clinical trials. The World Health Organisation (WHO) aims to ensure equitable access to safe, effective, and affordable vaccines of assured quality in LMICs, by facilitating regulatory pathways. An alternate approval pathway, based on safety and an immunological endpoint thought to predict clinical benefit (commonly referred to as serological threshold of risk reduction [SToRR]), is being considered for GBS maternal vaccines. Since this approach is new to many LMICs regulators and policymakers, WHO organized consultative meetings at national, regional, and global levels to discuss the feasibility and potential challenges of approving a GBS vaccine based on safety and immunogenicity data alone. These consultations focused on evidence supporting SToRR, their use as endpoints to infer protection, and post-licensure requirements. The aim of the consultations was to reduce the delay between vaccine development, licensure, policy recommendations and use in high-burden LMICs.
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