Genetic engineering of Meningococcal group B (4CMenB) vaccine for potential gonorrhoea protection in men who have sex with men (GBMSM) using Polymerase Chain Reaction (PCR) template.
In a significant public health move, the United Kingdom has launched an opportunistic vaccination programme targeting gay, bisexual, and other men who have sex with men (GBMSM) at higher risk of gonorrhoea infection. The programme, which started rolling out from 1 August 2025, is part of a broader response to the alarming rise in gonorrhoea cases among this group and concerns about increasing antibiotic resistance.
The programme is based on the endorsement of the Joint Committee on Vaccination and Immunisation (JCVI), which recommends the use of the 4CMenB vaccine in a targeted, opportunistic manner. This recommendation is for GBMSM attending sexual health clinics, as the vaccine, originally developed against meningitis B, offers a 30–40% reduction in gonorrhoea risk due to the genetic similarity between Neisseria meningitidis (meningitis B) and Neisseria gonorrhoeae (gonorrhoea).
The vaccination programme is detailed in the Green Book Gonorrhoea chapter, published in June 2025, and is operationalised through the use of a Patient Group Direction (PGD) template. This template, provided to support the provision of the 4CMenB vaccine specifically for GBMSM, facilitates its administration in relevant clinical settings.
The use of the template is a professional practice for practitioners, who are also expected to follow local policies and procedures to access the authorised documents. The authorisation process is a legal requirement outlined in the Human Medicines Regulations 2012, and the template for use is subject to authorisation in Section 2 as per these regulations.
The Green Book and the Summary of Product Characteristics are essential references for using the template. It is crucial to note that using the template before authorisation is a legal requirement. The template's use is regulated by the Human Medicines Regulations 2012, and its use in conjunction with the Summary of Product Characteristics for the vaccine is a professional practice for practitioners.
This marks a novel, off-label use of the 4CMenB vaccine aimed at addressing a significant public health challenge. The introduction of the vaccine is seen as an urgent, innovative intervention to reduce transmission and morbidity among GBMSM in the UK, where gonorrhoea cases among this group are 24 times higher than among heterosexual men in 2021/22.
The 4CMenB vaccine, originally developed for meningitis B, is now being used off-label as part of a targeted vaccination programme for gay, bisexual, and other men who have sex with men (GBMSM) attending sexual health clinics. This novel approach is aimed at reducing the alarming rise in gonorrhoea cases among this group and mitigating the concerns about increasing antibiotic resistance, as detailed in the Green Book Gonorrhoea chapter and operationalised through a Patient Group Direction (PGD) template.
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