GBS vaccines in the UK: a round table discussion

Area of Science:

• Immunology
• Vaccinology
• Public Health

Background:

• Group B Streptococcus (GBS) is a major cause of infant sepsis, meningitis, and death, despite antibiotic prophylaxis.
• Two GBS vaccine candidates are in advanced clinical trials, offering a potential solution to reduce infant mortality.
• Successful implementation requires addressing challenges in licensure, advocacy, Phase IV studies, and equitable access.

Purpose of the Study:

• To review the current status of GBS vaccines in the UK context.
• To focus on planning for Phase IV studies and identifying barriers to implementation.
• To foster cross-sector engagement among stakeholders involved in GBS vaccine licensure and evaluation.

Main Methods:

• A round-table discussion involving diverse UK stakeholders in GBS vaccine development and implementation.
• Review of UK GBS epidemiology, vaccine candidate coverage, and regulatory considerations.
• Exploration of Phase IV study methodologies, including cohort studies and randomized trials.

Main Results:

• Infant invasive GBS infection rates in the UK have risen, with higher rates observed in Black infants.
• Candidate GBS vaccines demonstrate high potential coverage (>95%).
• Regulatory bodies may waive pre-licensure efficacy studies if a correlate of protection is established.

Conclusions:

• An approved GBS vaccine is imminent, requiring immediate planning for Phase IV studies and implementation.
• Identifying and overcoming barriers to GBS vaccine implementation is critical.
• Cross-sector collaboration is essential for a successful GBS vaccine pathway.