Guidance

4CMenB vaccine for prevention of gonorrhoea: information for healthcare practitioners

Published 8 July 2025

Applies to England

This healthcare practitioner guidance is about the gonorrhoea vaccination programme. Ensure you use the correct guidance for the programme you are delivering.

Background

Gonorrhoea is a major global public health problem, with rising incidence and increasing resistance to all antibiotics used to treat the infection. Caused by the bacterium Neisseria gonorrhoeae, gonorrhoea was the second most common diagnosed sexually transmitted infection (STI) in England in 2022. If left untreated, it can cause complications such as pelvic inflammatory disease, ectopic pregnancy and infertility.

Gay, bisexual and other men who have sex with men (GBMSM) are at significantly higher risk of infection than heterosexuals, accounting for nearly half of all gonorrhoea diagnoses in England in 2022.

Gonorrhoea is transmitted through unprotected vaginal, oral or anal intercourse or genital contact with infected secretions. A person with the infection may have no symptoms but still transmit the infection. Typical symptoms of infection may include thick green or yellow discharge from the vagina or penis and pain on urination. Occasionally, gonorrhoea can cause serious complications such as pelvic inflammatory disease, ectopic pregnancy and infertility.

Natural infection does not give protection against future infections, and a recent history of gonorrhoea is a reliable predictor of future reinfection with gonorrhoea or other STIs.

There is currently no licensed vaccine against Neisseria gonorrhoeae. Although their clinical manifestations can be different, the bacterium that causes gonorrhoea (Neisseria gonorrhoeae) is very closely genetically related to the bacterium that causes meningococcal disease (Neisseria meningitidis). This gives the potential for cross-protection against Neisseria gonorrhoeae from the 4CmenB (Bexsero) vaccine which is used to protect against serogroup B meningoccocal disease. Studies have shown that 4CMenB, which is licensed for prevention of serogroup B (MenB) invasive meningococcal disease (IMD), also provides 30 to 40% protection against gonorrhoea. Please see the 4CmenB section for more information.

In November 2023, the Joint Committee on Vaccination and Immunisation (JCVI) advised a targeted, opportunistic vaccine programme using 4CMenB vaccine for protection against gonorrhoea primarily in GBMSM at higher risk of infection. This was done acknowledging that, as protection against gonorrhoea is not currently a licensed indication for 4CMenB vaccine, this advice is based on off-label use of the vaccine.

Resources

UKHSA resources

The primary resource is Immunisation against infectious diseases: the green book, including Gonorrhoea: the green book chapter.

Other resources within the UKHSA collection include:

• the Joint Committee on Vaccination and Immunisation (JCVI) advice and minutes
• a template PGD which is developed by UKHSA – this requires local sign-off before use and the document clearly sets out which staff can work to it and the training that is required in order to do so
• comprehensive training slideset
• patient information leaflets and free resources for health professionals implimenting the programme and public to order and download from Health Publications – these are also available in a wide range of languages and in Braille, easy-read and audio formats

Other resources

Official statistics for STIs: annual data provides incidence information STI diagnoses and sexual health services provided in England.

The Summary of Product Characteristics (SPC or SmPC) document and Patient Information Leaflet (PIL) for the vaccine are available from the Electronic Medicines Compendium.

The UKHSA provides guidance about storage and handling of vaccines, including the Green Book chapter 3.

Further information about legal mechanisms and who can use them is available from the Green Book chapter 5, the NHS Specialist Pharmacy Service patient group directions, patient specific directions and the Medicines and Healthcare products Regulatory Agency (MHRA).

Suspected adverse reactions following administration of 4CMenB vaccine should be reported to the MHRA using the Yellow Card scheme.

You can report suspected side effects electronically via:

• the Yellow Card website
• the free Yellow Card app – download now from the Apple App Store or Google Play Store
• some clinical IT systems for healthcare professionals (EMIS/SystmOne/Vision/MiDatabank/Ulysses/Cerner/Medicus)

Any patients who do not have online access to report a suspected side effect to the Yellow Card scheme can call 0800 731 6789 for free, Monday to Friday between 9am and 5pm.

The gonorrhoea vaccination programme

The aim of the gonorrhoea vaccination programme is to reduce the overall number of gonorrhoea cases. While the main benefit of a vaccination programme is expected to be at a community level, with a significant reduction in the number of cases overall, vaccinated individuals can expect to have some reduction in their own risk of contracting gonorrhoea.

Gonorrhoea vaccination eligibility

The main group who are eligible are GBMSM at increased risk of gonorrhoea attending a sexual health clinic should be opportunistically offered the 4CMenB vaccine.

For operational purposes, this group includes those:

• with bacterial sexually transmitted infection (such as gonorrhoea, chlamydia or syphilis) in the previous 12 months
• reporting sex with 5 or more sexual partners in the previous 3 months

Whilst gonorrhoea incidence remains highest in the eligible GBMSM group (as defined above), sexual health clinical professionals may perform individual risk assessments and consider the offer of 4CMenB to the small numbers of individuals with an incidence of gonorrhoea approaching that in the eligible group, such as sex workers practicing condomless sex, and others assessed as having a similar incidence as the eligible GBMSM group. Note that vaccination in these circumstances is outside the scope of the PGD and instead a PSD or a prescription must be used.

Healthcare practitioners should familiarise themselves with and follow the chapter on Gonorrhoea: green book and relevant operational guidance.

4CMenB vaccine

The vaccine used in the gonorrhoea vaccination programme is Bexsero®, and it contains 4 MenB antigen components (4CMenB).

Bexsero® is a multi-component inactivated vaccine made from 3 Neisseria meningitidis proteins produced by recombinant DNA technology (Neisseria meningitidis group B NHBA fusion protein, Neisseria meningitidis group B NadA protein, Neisseria meningitidis group B fHbp fusion protein) and a preparation of Neisseria meningitidis capsular group B outer membrane vesicle (OMV) Neisseria meningitidis group B strain NZ98/254).

Bexsero® has been approved for use in 47 countries across a variety of age ranges since its initial license was granted in 2013. Since September 2015 it has been in use in the UK childhood immunisation schedule for the prevention of meningococcal disease (meningitis and septicaemia) and for UK adolescents and adults who are deemed to be at increased risk (individuals with underlying medical conditions such as asplenia, splenic dysfunction or complement disorder or laboratory staff handling relevant clinical samples).

Twenty countries in addition to the UK also use Bexsero® in children, adolescents and adults who are deemed to be at increased risk of exposure. This means there is extensive real world and clinical trial data to show that Bexsero® 4CMenB is safe and immunogenic when used against MenB in the adolescent and adult population.

4CMenB use for gonorrhoea

Observational studies carried out in adolescents and young adults in Canada, Australia and the USA have found lower incidence of gonorrhoea in individuals vaccinated with 4CMen B compared with unvaccinated individuals. A 2024 systematic review of published cohort and case-controlled studies estimated a pooled 4CMenB vaccine effectiveness of 33 to 34% (Wang et al.). Real world data from South Australia, where 4CMenB is routinely offered to adolescents, estimate that the vaccine provided 46% protection against gonorrhoea for at least 4 years after vaccination (Wang et al.).

The vaccine is estimated to provide around 30 to 40% protection against gonorrhoea for at least 4 years after vaccination. The vaccine does not provide complete protection against gonorrhoea, so condoms are important to protect not only against gonorrhoea but other STIs.

Vaccine presentation

Bexsero® 4CMenB vaccine is supplied as a white opalescent liquid suspension (0.5ml) in a pre-filled syringe (single pack size) for injection.

Vaccine excipients

Bexsero® 4CMenB vaccine does not contain thiomersal or porcine gelatine. The tip cap and rubber plunger stopper of the pre-filled syringe are made with synthetic rubber. For a full list of excipients, healthcare professionals should read the manufacturer’s summary of product characteristics (SmPC).

Shelf life

Bexsero® 4CMenB has a shelf life of 4 years when stored in line with manufacturer recommendations.

Vaccine storage

Bexsero® 4CMenB should be stored in a vaccine refrigerator between +2°C and +8°C. Do not freeze. The vaccine should be stored in the original packaging to protect it from light.

Further information on vaccine storage is available in the SmPC, the PGD and from the manufacturer.

Vaccine dosage and schedule

4CMenB is a 2-dose course of vaccine. Each dose is 0.5ml. The second dose of vaccine can be given at any time after an interval of at least 4 weeks between the 2 doses. There is no maximum time interval limit between the 2 vaccine doses. Pragmatically and opportunistically, the second dose can be scheduled for the next clinic attendance, which may be after 3, 6 or 12 months.

If the primary course of 4CMenB has been started, there is no need to repeat doses or restart the course even if there is a prolonged interval between the 2 doses.

Booster

There are currently no recommendations for 4CMenB booster doses in eligible adults who have received 2 doses of the vaccine.

Vaccine administration

Bexsero® 4CMenB is supplied in a pre-filled syringe and should ideally be administered by intramuscular (IM) injection, preferably into the deltoid region of the upper arm.

Localised reactions are more common with subcutaneous injection. However, for individuals with a bleeding disorder, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding.

Vaccine administration for individuals with bleeding disorders

Individuals with bleeding disorders may be vaccinated intramuscularly if, in the opinion of a doctor familiar with the individual’s bleeding risk, vaccines or similar small volume intramuscular injections can be administered with reasonable safety by this route. If the individual receives medication or treatment to reduce bleeding, for example, treatment for haemophilia, intramuscular vaccination can be scheduled shortly after such medication or treatment is administered.

Individuals on stable anticoagulation therapy, including individuals on warfarin who are up to date with their scheduled INR testing and whose latest INR was below the upper threshold of their therapeutic range, can receive intramuscular vaccination. A fine needle (equal to 23 gauge or finer calibre, such as 25 gauge) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes.

If in any doubt, consult with the clinician responsible for prescribing or monitoring the individual’s anticoagulant therapy.

The individual or carer should be informed about the risk of haematoma from the injection.

Administration of 4CMenB during pregnancy or while breastfeeding

There is no data on the use of 4CMenB in pregnant women and during breastfeeding but as a precautionary measure, it is preferable to avoid the use of 4CMenB during pregnancy or breastfeeding, unless, following a risk assessment by a healthcare professional, it is felt that there is sufficient risk of exposure to meningococcal or gonococcal infection to recommend the vaccine. The benefit-risk ratio must be examined before making the decision to immunise pregnant or breast-feeding women.

If the 4CMenB vaccine is inadvertently administered to a pregnant woman, the individual should be informed and reassured that there is no known risk associated with giving 4CMenB during pregnancy since, as it is a non-live vaccine, it cannot replicate and therefore cannot cause infection in the mother or foetus. The individual should be advised to seek medical advice for any concerns.

Co-administration with other vaccines

Vaccinating in a timely manner when an eligible individual is present in the clinic will avoid any delay in protection and reduce the risk of the individual not returning for a later appointment.

4CMenB can be administered before, at the same time as, or after all other vaccines currently (including but not limited to hepatitis A, hepatitis B, human papillomavirus and mpox vaccines that are offered in sexual health clinics) without any restrictions on time intervals between different vaccines. First principles would suggest that any interference between co-administered vaccines with different antigenic content is likely to be limited and any potential interference is most likely to result in a slightly attenuated immune response to one of the vaccines (see Gonorrhoea: the green book chapter and UK immunisation schedule: the green book, chapter 11).

Any co-administered vaccines should be given at separate sites, preferably in separate arms.

Vaccine ordering

4CMenB vaccines for the national gonorrhoea vaccination programme should be ordered via the ImmForm website. Healthcare practitioners should refer to this website and Vaccine update (the vaccination newsletter for healthcare practitioners) for up-to-date information on vaccine availability. As the programme is a year-round programme and not a seasonal programme, vaccines should be ordered regularly throughout the year.

Healthcare practitioners are reminded to only order what they need for a 2 to 4 week period rather than over-ordering or stockpiling vaccines. Vaccines should be ordered, stored and monitored as described in the Green Book Chapter 3: Storage, distribution and disposal of vaccines.

Adverse reactions commonly associated with 4CMenB vaccination

The most commonly reported adverse reactions following vaccination with 4CMenB in adolescents and adults are pain at the injection site, malaise and headache.

Contraindications and precautions to 4CMenB vaccine

There are very few individuals who cannot receive 4CMenB vaccines. When there is doubt, appropriate advice should be sought from a consultant in sexual health services, immunisation co-ordinator or consultant in communicable disease control, rather than withhold immunisation.

The vaccines should not be given to those who have had:

• a confirmed anaphylactic reaction to a previous dose of the vaccine
• a confirmed anaphylactic reaction to any constituent or excipient of the vaccine

Individuals presenting with minor illness

Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have recovered fully. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to the adverse effects of the vaccine.

Fever and the use of prophylactic paracetamol after vaccination  

A high fever is an adverse reaction observed in children following Bexsero® administration. Prophylactic liquid paracetamol is recommended for infants under one year of age when receiving Bexsero®. As high fever (and associated febrile convulsions) are not commonly observed in children over 2 years, adolescents and adults, there is no requirement for prophylactic paracetamol after vaccination in the gonorrhoea vaccination programme. However, paracetamol can be taken if required (for example, if a headache or other commonly reported adverse reaction is experienced).

Reporting adverse reactions following vaccination

Serious suspected adverse reactions to any vaccine, including the vaccine used to protect against gonorrhoea, should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the yellow card reporting scheme.

History of infection, exposure or previous vaccination

Vaccination of individuals with no previous history of gonorrhoea infection

As gonorrhoea infection can be asymptomatic, individuals may be unaware of any previous infection. Natural infection does not induce protective immunity and recurrent infections are common. This means that individuals who meet the eligibility criteria for vaccination attending a sexual health clinic should be opportunistically offered the 4CMenB vaccine irrespective of any previous history of gonorrhoea infection.

Vaccination and treatment of individuals with current or recent gonorrhoea infection

Eligible individuals attending sexual health clinics for testing and/or management of bacterial STIs, including gonorrhoea, should be offered 4CMenB at the same clinic attendance.

It is possible that acute gonorrhoea may affect immune responses to vaccination since natural infection does not confer protection against reinfection. Even if some attenuation in vaccine response did occur with the first dose, eligible individuals will receive a second dose of the same vaccine after the infection is treated. UKHSA will closely monitor the impact of vaccination during active or recent gonorrhoea infection to inform future vaccine recommendations.

There is no evidence of 4CMenB clearing acute gonorrhoeal infection. Acute infections should be managed according to the British Association for Sexual Health and HIV (BASHH) guidelines.

Vaccination interval after exposure to gonorrhoea

4CMenB vaccine can still be offered if an individual has recently been exposed to gonorrhoea, without any interval, providing the patient has no known contraindications to the vaccine.

Vaccinated individuals presenting with a gonorrhoea infection

As the vaccine does not provide complete protection against gonorrhoea, cases will continue to occur in vaccinated individuals. There is no requirement for additional reporting of these cases (they are expected, not vaccine failures) and a history of previous or recent vaccination should not alter their management. If the individual has only received one dose of 4CMenB, the second dose should be administered at the appropriate interval (a minimum of 4 weeks after the first dose).

Vaccination of eligible individuals who have previously received 4CMenB

Some individuals may have received a two doses of 4CMenB previously, either because they have accesed this privately, or because they are at higher risk of meningoccocal disease. This includes individuals with human immunodeficiency virus (HIV) infection (irrespective of CD4 count), asplenia and complement deficiency (including those on complement inhibitors). Irrespective of when they received their previous doses no further doses are recommended for these individuals.

Eligible individuals who have previously received only one 4CMenB dose can be offered a second dose at any time after an interval of at least 4 weeks since their previous dose. There is no maximum time interval between the 2 vaccine doses.

If the individual has an uncertain or unknown vaccine history, the vaccinator should assume them to be unimmunised and offer 2 doses of vaccine as per the recommendations for the gonorrhoea vaccination programme.

Vaccination of eligible individuals who have previously received another MenB vaccine

While there are different MenB vaccines licensed for use in other countries, Bexsero® is the only vaccine recommended for use in the UK gonorrhoea vaccination programme. Evidence has shown that other MenB vaccines do not offer the same cross protection for gonorrhoea. Therefore, previous vaccination with a MenB vaccine other than 4CMenB should be discounted, and the individual should be offered 4CMenB.

Individuals who have an incomplete course of 4CMenB vaccine

If the course of 4CMenB vaccine is interrupted or delayed it should be resumed as soon as possible to provide protection, but the first dose should not be repeated. There is no maximum time interval between the 2 vaccine doses and no need to recommence the primary immunisation schedule even after a prolonged interval between the 2 doses.

Inadvertent vaccine administration errors

Healthcare practitioners should report all inadvertent vaccine administration errors via their local governance system(s) so that appropriate action can be taken, lessons can be learnt and the risk of future errors minimised.

Inadvertent early administration of the second dose

The recommended schedule for 4CMenB vaccine is 2 doses, with the second dose given 4 weeks after the first dose.

If the second dose is given earlier than 4 weeks after the first dose, this dose should be discounted. A repeat dose should be given ensuring an interval of at least 4 weeks after the last dose. Pragmatically and opportunistically, the repeat dose can be scheduled for the next clinic attendance, which may be after 3, 6 or 12 months.  

Incomplete dose administered

If an incomplete dose of 4CMenB has been given inadvertently (for example, if some vaccine spills or leaks out as vaccine is being administered), the vaccine will usually need to be repeated, as the dose the patient received may not be sufficient to evoke a full immune response. The vaccine should ideally be repeated on the same day or as soon as possible thereafter.

Additional dose administered in error

If an individual was due to receive another vaccine alongside their 4CMenB dose (for example hepatitis A, hepatitis B, HPV and/or MPox), but they received 2 doses of 4CMenB in error, the individual should be advised of the error and reassured that whilst they may experience increased reactogenicity (side effects), no additional interventions are required. If the error occurred during the first dose, the course should still be completed and the second dose still offered at the appropriate interval.

Any co-administered vaccines due to be administered during the appointment may still be administered.

References

1. Wang, Bing et al. Vaccine effectiveness and impact of meningococcal vaccines against gonococcal infections: A systematic review and meta-analysis Journal of Infection, Journal of Infection. volume 89, issue 3, 106225. 2024

2. Wang et al. Long-term 4CMenB Vaccine Effectiveness Against Gonococcal Infection at Four Years Post–Program Implementation: Observational Case–Control Study, Open Forum Infectious Diseases, volume 12, issue 1, January 2025.

Document history

Version number	Change details	Date
01.00	New information document	July 2025