Meningococcal B vaccination programme for infants: information for healthcare practitioners

Question 1

Introduction

Accepted Answer

In September 2015, a vaccine against MenB was added to the childhood immunisation programme as part of the routine schedule in England. This document provides further information for healthcare practitioners about the MenB vaccine (Bexsero®, also known as 4CMenB) and the MenB vaccination programme offered at 8 and 16 weeks with a booster at 1st birthday.

Question 2

Meningococcal disease

Accepted Answer

Meningococcal disease is caused by invasive infection with the bacterium Neisseria meningitidis (N. meningitidis). There are 12 identified capsular groups of N. meningitidis of which groups B, C, W and Y were historically the most common cause of invasive meningococcal disease (IMD) in the UK. IMD is rare but extremely serious, most commonly presenting as either meningitis or septicaemia, or a combination of both. Other sterile sites such as the pericardium, lungs or joints can be affected, though this is more rare.

Meningococci commonly colonise the nasopharynx of humans and usually do not cause invasive disease. Between 5% and 11% of adults and up to 25% of adolescents carry the bacteria without any signs or symptoms of the disease, although carriage rates appear to be lower in more recent studies. In infants and young children, the carriage rate is low.

The meningococci are transmitted by respiratory aerosols, droplets or by direct contact with the respiratory secretions of someone carrying the bacteria. The incubation period is from 2 to 7 days and the presentation of disease ranges from severe acute and overwhelming features, to insidious with mild prodromal symptoms.

Question 3

Risk of meningococcal disease

Accepted Answer

Since the introduction of the routine MenC vaccination programme in 1999, and the MenACWY teenage vaccine in 2015, cases of IMD in the UK due to capsular groups C, W and Y reduced significantly across all age groups with only ad hoc cases now arising.

Prior to the introduction of the infant MenB and teenage MenACWY immunisation programme, MenB was responsible for 58% (418 of 724) of all cases of IMD in 2014 to 2015^{[footnote 1]} with the highest incidence being reported among infants, followed by toddlers and then adolescents aged 15 to 19.

The MenB infant programme has reduced the disease in vaccinated cohorts by around 75% when compared with trends in unvaccinated cohorts. The vaccine is effective against MenB IMD in vaccinated individuals but does not protect against carriage of the meningococcus and therefore will not lead to herd protection across the wider population.

Population measures to control the COVID-19 pandemic during 20202 to 2021 reduced the incidence of other infections, including invasive meningococcal disease. Following the withdrawal of all population control measures in July 2021, meningococcal disease re-emerged and MenB disease accounted for 89% of all IMD between September 2021 and August 2024.

It can affect anyone in all age groups, but the rates of disease are highest in children under 2 years of age. The overall risk of IMD is very low (less than 1 per 100,000 population per anum)^{[footnote 2]}. Meningococcal cases increase from birth and, following the introduction of the MenB vaccination programme, peak at 2 to 3 months before declining gradually until 24 months^{[footnote 3]}. Cases remain low until 12 years of age and then gradually increase to a smaller peak at 18 years before declining again.

Individuals with asplenia, splenic dysfunction or complement disorders are also at an increased risk of IMD and should be immunised in accordance with chapter 7 of the Green Book: Immunisation of individuals with underlying medical conditions.

The latest epidemiological data is available at Meningococcal disease: guidance, data and analysis.

Question 4

The MenB vaccine (Bexsero®)

Accepted Answer

Bexsero® (which may also be referred to as 4CMenB) is the recommended vaccine for the routine infant immunisation programme.

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).

Whilst Bexsero® has broad coverage against most MenB strains causing IMD in England, it does not offer complete protection. Unlike the vaccines based on conjugated polysaccharide, it cannot protect against all the strains of bacteria within group B but it has been designed to protect against the most commonly circulating strains of MenB.

Vaccine excipients

Bexsero® does not contain thiomersal or porcine gelatine. For a full list of excipients, healthcare professionals should read the manufacturer’s summary of product characteristics (SmPC).

Question 5

Vaccine response and efficacy

Accepted Answer

Bexsero® has been shown to be immunogenic in infants and toddlers. Clinical trials for Bexsero® in infants initially included 3 doses followed by a booster in the second year of life. However, clinical trials indicate that 2 Bexsero® doses given 2 months apart can induce protective bactericidal antibodies (antibodies that kill the bacteria), against MenB in nearly all infants (see the SmPC for more information). Vaccine responses will also be boosted after the 12-month dose.

Vaccine-induced antibodies have been shown to be bactericidal against most MenB strains causing invasive disease in the UK. However, Bexsero® was licensed on immunogenicity studies because the incidence of MenB disease was too low for clinical trials to provide a measure of efficacy.

A number of countries such as Cuba, Norway and New Zealand had previously used MenB vaccines derived from outer membrane vesicles (OMVs) of specific meningococcal B strains responsible for large outbreaks in their respective countries. A key limitation of these vaccines is that they mainly protect against specific MenB strains and do not provide broad cross-protection against other MenB strains causing invasive disease. In New Zealand, vaccine effectiveness for the OMV component of their vaccine was estimated to be 73%.

The cost-effectiveness model reviewed by the Joint Committee on Vaccination and Immunisation (JCVI) assumed that 88% of meningococcal B strains causing invasive disease in England would be covered by Bexsero® and vaccine effectiveness against these strains would be 95%.

Within 10 months of implementing Bexsero® into the UK infant immunisation programme, the vaccine was found to be 83% effective against all MenB disease in vaccine eligible infants, which was equivalent to 94% protection against the predicted 88% vaccine-preventable strains. Moreover, Parikh and others^{[footnote 4]} reported that MenB cases in the vaccine-eligible cohort had nearly halved, compared to the 4 years prior to Bexsero® introduction.

More recent studies^{[footnote 5]} to the end of August 2018 found a 75% reduction in MenB disease in age groups that were fully eligible for vaccination with an estimated 277 cases (95%CI, 236 to 323) prevented in the first 3 years of the programme. Vaccine effectiveness was estimated at 59.1% (95% CI, -31.1 to 87.2) with a 2-dose priming schedule plus a booster at 1 year.

Duration of protection

When reviewing all of the available evidence, the JCVI agreed the most plausible duration of protection was thought to be 18 months following a 2-dose primary course, and 36 months following the additional booster dose administered at 12 months of age. These estimates were based on the waning antibody responses observed in infant clinical trials.

Ladhani and others^{[footnote 5]} further evaluated the effectiveness of 4CMenB in preventing invasive meningococcal group B disease in 2020. This evaluation reported that the incidence of meningococcal B disease in England was significantly lower in vaccine-eligible cohorts than the expected incidence. During the period under evaluation (September 2015 to August 2018), 169 cases of meningococcal group B disease were reported in the vaccine-eligible cohorts, and 277 cases were prevented. The authors concluded that protection after receipt of 2 doses plus a booster dose was sustained for at least 2 years.

Bexsero® should, therefore, help protect infants and toddlers during their period of highest risk of meningococcal B infection.

Cross protection against other meningococcal capsular groups

Whilst Bexsero® has broad coverage against most MenB strains causing IMD in England, it does not offer complete protection. However, it can offer protection against some non-MenB strains because it is not targeting the outer polysaccharide that is group specific. An English study^{[footnote 5]} has generated real-world evidence that 4CMenB vaccine offers some protection against the hypervirulent MenW strain that was circulating during the 2010s, and that led to to the introduction of the MenACWY programme.

However, it is important that individuals requiring protection against meningococcal serogroups A, C, W and Y should receive the MenACWY conjugate vaccine and should not be assumed to be protected against these capsular groups even if they have received a complete course of Bexsero®.

Vaccine supply

Bexsero® for use in the national programme should be ordered via the ImmForm website and healthcare professionals should refer to this website and Vaccine update (the monthly vaccination newsletter for health practitioners) for up-to-date information on vaccine availability.

Shelf life of Bexsero®

Bexsero® has a shelf life of 4 years when stored in its original packaging in a refrigerator within the recommended temperature range of +2 degrees Celsius (°C) and +8°C. Bexsero® should not be frozen. It is recommended that health professionals only order what they need for a 2 to 4 week period.

To ensure vaccines are ordered, stored and monitored as per national recommendations, healthcare professionals should familiarise themselves with the recommendations made in chapter 3 of the Green Book: Storage, distribution and disposal of vaccines.

Question 6

The meningococcal B vaccination programme

Accepted Answer

Schedule

It is recommended that the first 2 doses of MenB vaccine be administered together with the other primary immunisations at 8 weeks and 16 weeks and the third dose given on or after the first birthday (2+1 schedule).

These recommendations differ from the Bexsero® SmPC and healthcare professionals are reminded that where recommendations regarding vaccines given in the Green Book differ from those in the SmPC for a particular vaccine, the recommendations in the Green Book, which are based on current expert advice received from the JCVI, should be followed.

The basis of the JCVI recommendation for a 2+1 schedule is from studies of clinical trials which have shown that nearly all infants develop bactericidal antibodies against MenB vaccine antigens following 2 doses of Bexsero® given 2 months apart.

Eligibility for the meningococcal B immunisation programme

Following review of the epidemiological and economic evidence as well as vaccine safety and efficacy, the JCVI recommended that young infants were prioritised, with the aim of providing optimal protection as early as possible because they have the highest disease incidence. The meningococcal B vaccine, Bexsero®, became available through general practitioner (GP) services from 1 September 2015. As meningococcal disease incidence peaks around 5 months of age, the priority of the infant MenB immunisation programme is to ensure that Bexsero® is offered routinely to infants before this peak.

Infants attending their GP practice for their routine primary immunisations at 8 weeks and 16 weeks of age should be offered meningococcal B vaccine along with their routine infant immunisations, followed by a booster on or after their first birthday.

Children remain eligible to receive Bexsero® vaccine until they reach 2 years of age.

If the course is started late, the interval between doses can be reduced to 4 weeks to ensure 2 doses of vaccine can be administered before the infant reaches 2 years of age.

MenB vaccine is not indicated for children after their second birthday unless they are in a risk group (as defined in chapter 7 and chapter 22 of the Green Book). Children born before 1 May 2015 are not eligible for the MenB vaccine unless they are in a clinical risk group.

Infants ages 6 to 8 weeks of age

Infants may receive their first dose of primary immunisations from 6 weeks of age in exceptional circumstances (such as pre-travel) but it is not routinely recommended to offer infants their primary immunisations before 8 weeks of age.

Bexsero® vaccine is licensed from 8 weeks of age. If administered to infants between 6 and 8 weeks of age, a patient-specific direction (PSD) will be required as the patient group direction (PGD) does not include infants younger than 8 weeks of age. Parents should also be informed that paracetamol prescribing guidance will usually advise that infants younger than 2 months of age should not receive paracetamol. As paracetamol is recommended to be administered around the time of Bexsero® vaccination, the advice in Table 1 should be followed and infants aged 6 to 8 weeks of age should receive the same dose of infant paracetamol suspension (2.5ml) as an 8-week-old baby.

Parents should be provided with the UKHSA leaflet on paracetamol use and reassured that paracetamol is given to infants younger than 2 months of age when clinically required (for example to infants in SCBU and those admitted to hospital in the first few weeks of life).

Children 2 years of age and older

Although not part of the routine programme, if Bexsero® vaccine is clinically indicated for those aged 2 years and older (for example for those with asplenia, splenic dysfunction or complement disorders), the national immunisation stock can be used.

Some parents may opt to make alternative arrangements to have their child immunised with the MenB vaccine if their child does not meet the eligibility criteria for the routine programme. Parents should be informed that if the vaccine is not clinically indicated and a private arrangement is made for vaccination, the provider may charge for the service as this arrangement is outside of the national programme.

Question 7

Adverse reactions commonly associated with the administration of Bexsero®

Accepted Answer

In clinical trials, the most common adverse reaction observed in infants and children under 2 years of age was a high rate of fever (more than 38°C) when Bexsero® was administered with the other routine childhood vaccines (see below).

Other very common adverse reactions (occurring in more than 1 in 10 children) observed in infants and children (up to the age of 10 years) are tenderness at the injection site (including severe tenderness defined as crying when moving injected limb), rash, swelling or induration at the injection site, irritability, change in feeding or eating, sleepiness and unusual crying.

Bexsero® is no longer subject to additional monitoring under the black triangle labelling scheme by the Medicines and Healthcare products Regulatory Agency (MHRA) but all suspected serious adverse reactions should continue to be reported to the MHRA using the Yellow Card scheme.

Question 8

Prophylactic paracetamol

Accepted Answer

Following vaccination, infants may experience symptoms such as fever, irritability and reduced appetite. Infants receiving prophylactic paracetamol when Bexsero® is administered with routine immunisations are less likely to experience these symptoms.

Fever and the use of prophylactic paracetamol after vaccination

Fever after vaccination with or without Bexsero® is common and nearly always under 39°C. Fever is a normal and expected response of the immune system against the vaccine antigens and is generally not harmful but parents are often concerned about the risk of febrile convulsions or ‘fever fits’. Typically, febrile convulsions occur from 6 months to 5 years of age and are very uncommon in younger age groups. In clinical trials involving several thousand infants receiving their routine vaccinations (including Bexsero®), febrile convulsions were very rarely reported. In one of the largest Bexsero® trials, Gossger and others^{[footnote 6]} recruited and vaccinated 1,885 infants at 4 different visits without paracetamol prophylaxis and only one infant developed a febrile convulsion 2 days after receiving Bexsero®. In the subsequent study of 364 infants receiving Bexsero® with or without paracetamol, Prymula and others ^{[footnote 7]} reported that there wasn’t a single case of febrile convulsion after any of the 4 vaccination visits.

If a parent suspects that their infant has had a convulsion or another serious reaction following administration of any vaccine, including Bexsero®, they should be advised to seek medical attention and report it via the Yellow Card Scheme.

Risk of fever when Bexsero® is administered at the same time as other routine childhood vaccines

In one clinical trial, fever (equal to or more than 38°C) was reported in 51% to 62% of infants receiving Bexsero® and routine vaccines administered together, although high fever (equal to or more than 39°C) was less common (6% to 12%). Overall, fever (equal to or more than 38.0°C) after any vaccination was reported in 76% of infants receiving Bexsero® and routine vaccines together, compared to 51% in infants receiving the routine vaccinations alone. However, only 6 of the 1,885 recruited infants attended hospital because of fever within 2 days after vaccination with Bexsero® in this study.

In the study conducted by Prymula and others^{[footnote 7]}, 70% of infants receiving Bexsero® had fever (equal to or more than 38.5°C) at least once in the first 3 days after any primary dose. Fever was less common (39%) in infants receiving prophylactic paracetamol just before, or at the time of vaccination, followed by 2 further administrations by parents or guardians at 4 to 6 hour intervals after vaccination. Around 5% of infants receiving paracetamol had fever (equal to or more than 39°C) and the frequency of medically attended fever within 3 days of vaccination was equal to or more than 2% for any vaccination visit, irrespective of whether Bexsero® was administered alone or with the routine vaccinations. The study by Prymula and others was also important because it showed that responses to Bexsero® and the routine vaccinations were not affected by administering prophylactic paracetamol at the time of vaccination.

In another vaccine study that assessed the effect of medications to prevent fever following the pneumococcal conjugate vaccine Prevenar 13 (which did not include Bexsero®)^{[footnote 8]}, infants receiving 3 doses of paracetamol (at vaccination and at 6 to 8 hour intervals) were half as likely to develop post-vaccination fever, and also half as likely to develop high fever (more than 39°C), when compared with infants receiving 2 doses of paracetamol (first dose at 6 to 8 hours after vaccination and another 6 to 8 hours later). This indicates that the greatest benefit in reducing post-vaccination fever appears to come from the paracetamol dose given around the time of vaccination.

For the Bexsero® programme, the JCVI has recommended 3 doses of paracetamol to be given to infants receiving Bexsero® with their routine primary immunisations at 8 weeks and 16 weeks. Prophylactic paracetamol is not recommended for the 12-month boosters because the infants are older and rates of fever are similar with and without Bexsero® administration at this age. Guidance on the use of liquid prophylactic paracetamol can be found below.

Some babies may still develop fever after vaccination, even after taking paracetamol. Parents can be advised that if their baby still has a fever after the first 3 doses of paracetamol but is otherwise well, they can continue to follow UKHSA post-immunisation paracetamol dosing recommendations (see Paracetamol product licensing). There should always be at least 4 hours between doses and they should never give more than 4 doses in a day. The child should also be kept cool by making sure they don’t have too many layers of clothes or blankets on, and they should be offered plenty of fluids. If there are any concerns about the baby at any time, advice should be taken from a GP or by calling 111. Information on the use of ibuprofen for post-vaccination fever can be found below.

If Bexsero® is administered separately to other routine primary immunisations (for example at a different appointment), liquid paracetamol is not needed as the risk of fever is reduced.

Using prophylactic infant paracetamol suspension with Bexsero® vaccine

As fever has been a very common adverse reaction in trials and in light of concerns raised that an increase in fever may have a detrimental impact on the uptake of future immunisations, the JCVI issued a position statement which recommended the use of prophylactic paracetamol at the time of immunisation with Bexsero®.

The JCVI also advised that parents and healthcare professionals need to be informed and updated about the change in advice regarding the use of prophylactic paracetamol and the reactogenicity of Bexsero® when administered concomitantly with other routine childhood immunisations to reduce any anxiety or concern.

This is a change to previous advice whereby the prophylactic use of antipyretics was not routinely recommended as there was some evidence that they lowered the immune response to some of the routine infant vaccinations. Additionally, it was also felt that a low-grade fever was to be expected following immunisation and such a response was an indication that the vaccine was triggering the appropriate immunological response. The latter remains true. However, the incidence of fever greater than 38°C when Bexsero® is administered at the same time as other childhood vaccines is greatly increased.

Additionally, studies have shown that giving a dose of paracetamol around the time of vaccination followed by a further 2 doses at 6 to 8 hourly intervals significantly reduced the rates of fever associated with vaccination without affecting the immunogenicity of Bexsero® or other routine infant vaccines.

It is recommended that parents should be advised to give 2.5ml (120mg/5ml) of infant paracetamol to their babies around the time of immunisation or as soon as possible after the vaccines are administered, and to give 2 further doses at 4 to 6 hourly intervals (Table 1).

Infants aged 6 to 8 weeks of age who are receiving a first dose of Bexsero® early (for example, infants travelling to another country before they reach 8 weeks of age), should receive infant paracetamol suspension as described in Table 1 for infants aged 8 weeks.

Prophylactic paracetamol is not recommended for the 12-month boosters because the infants are older and rates of fever are similar with and without Bexsero® administration at this age.

Table 1. Dosage and timing of infant paracetamol suspension (120mg/5ml) for the routine immunisation programme at 8 and 16 weeks [note 1]

Age of baby	Dose 1	Dose 2	Dose 3
8 weeks	One 2.5ml at the time of or as soon as possible after vaccination	One 2.5ml 4 to 6 hours after 1st dose	One 2.5ml 4 to 6 hours after 2nd dose
16 weeks	One 2.5ml at the time of or as soon as possible after vaccination	One 2.5ml 4 to 6 hours after 1st dose	One 2.5ml 4 to 6 hours after 2nd dose

Note 1: For premature babies, the dose should be calculated according to the infant’s weight around the time of vaccination.

Reccomendations for premature babies

Infants born at more than 32 weeks’ gestation should receive the vaccine at the appropriate chronological age (age from date of birth) without correction for prematurity. The dose of prophylactic paracetamol should be calculated according to the infant’s weight around the time of vaccination.

Alerting parents to the need to buy paracetamol prior to vaccination

Healthcare professionals should provide parents with the UKHSA leaflet on paracetamol use before their infant’s 8-week primary vaccination appointment (for example when the parents register their baby at the practice or when they attend the 6 to 8 week check). This will alert parents to the need to buy liquid paracetamol in preparation for the 8-week immunisation appointment. Most local pharmacies, supermarkets and many local stores stock infant liquid paracetamol suspension.

Paracetamol product licensing

The Commission on Human Medicines was consulted regarding the previous licencing restriction on pharmacy and general sales list paracetamol products which advised consulting a GP or pharmacist if more than 2 doses were required for an 8-week-old infant post-immunisation. This was to ensure early diagnosis of systemic bacterial infection.

The licence was updated during 2016 and supports the UKHSA recommendations for paracetamol use following MenB vaccination (also see Table 1 above).

This recommendation is based on the likelihood that fever is due to immunisation. This recommendation does not extend to fever at any other time and if the infant is otherwise unwell parents should trust their instincts and not delay seeking medical attention for their infant. Parents can be reassured that it is appropriate to follow UKHSA post-immunisation paracetamol dosing recommendations. Advice on bottles and sachets of infant paracetamol has now been changed to reflect the recommendation that paracetamol can be given for relief of fever after vaccinations from 2 months of age. In the event that Bexsero® is required to be administered to an infant aged 6 to 8 weeks, the paracetamol recommendations in Table 1 should be followed.

Liquid paracetamol supply

Nurses and midwives can only supply or administer medicines using a recognised process. Standards for medicines management that were previously issued by the Nursing and Midwifery Council (NMC) were withdrawn in January 2019 but guidance on where to find further information on the safe and effective handling, management and administration of medicines is available on the NMC website. Nurses should advise parents that they need to ensure that they have liquid paracetamol available for their infant at the time of vaccination and at home for the next 2 days if needed.

Ibuprofen as an alternative to paracetamol to reduce post-vaccination fever after Bexsero®

In a head-to-head clinical trial of prophylactic paracetamol versus ibuprofen to reduce post-vaccination fever, ibuprofen (2 or 3 doses) did not reduce the rate or intensity of post-vaccination fever compared to the control arm where infants did not receive any anti-pyretic. This suggests that paracetamol should be the only recommended prophylactic anti-pyretic to reduce post-vaccination fever in infants. For this reason, ibuprofen should not be used as an alternative to prophylactic paracetamol at the time of vaccination, but can be used for treatment if the infant subsequently develops a post-vaccination reaction, including fever. If an infant still has a fever 48 hours after vaccination or if parents are concerned about their infant’s health at any time, then advice should be taken from a GP or NHS 111.

Incomplete dose of liquid paracetamol

If the infant spits out or regurgitates at least half of the paracetamol suspension, then an additional dose (one dose of 2.5ml spoonful) of liquid paracetamol should be administered. If the second dose is spat out, do not give a third dose.

Administering oral rotavirus vaccine at the same time as liquid paracetamol

If possible, give Rotarix® vaccine and prophylactic paracetamol with a short interval between them. Although the live vaccine virus is unlikely to be affected by close sequential administration of a small volume of paracetamol syrup, leaving a short interval between the vaccine and the paracetamol syrup may reduce the chance of the rotavirus vaccine being vomited back up.

Question 9

Vaccine preparation and administration

Accepted Answer

Preparing Bexsero® vaccine

The vaccine comes in a box that contains a prefilled syringe with a volume of 0.5ml. During storage, the contents of the syringe may settle with off-white deposits being noticeable. Before use, the pre-filled syringe must be shaken well so that any observable deposits are thoroughly mixed into the liquid, forming a homogenous suspension that should be administered immediately. The vaccine should not be administered where there are variations in physical appearance (such as having the appearance of a non-homogenous suspension) or there are signs of foreign particulate observed after shaking.

Administering Bexsero® vaccine with other vaccines

Bexsero® can be given at the same time as, or at any interval from, all of the other vaccines administered as part of the routine childhood immunisation programme.

Bexsero® vaccine contraindications

There are very few infants who cannot receive meningococcal vaccines. Where there is doubt, instead of withholding immunisation, appropriate advice should be sought from a consultant paediatrician with immunisation expertise, a member of the Screening and Immunisation Team or from the local UKHSA health protection team.

Bexsero® should not be administered to those who have had:

a confirmed anaphylaxis to a previous dose of the vaccine

Or:

a confirmed anaphylaxis to any constituent or excipient of the vaccine

For the composition and full list of excipients of the vaccine, please refer to the manufacturer’s SmPC.

Administering Bexsero® to infants less than 12 months of age

When Bexsero® was introduced to the national vaccination programme, it was recommended that the vaccine be administered via intramuscular injection into the anterolateral aspect of the left thigh, ideally on its own, so that any local reactions could be monitored more accurately. If another vaccine needs to be administered in the same limb, then they must be given at least 2.5cm apart. The site at which each vaccine is given should be noted in the individual’s health records.

Administering Bexsero® at 12 months of age

Infants attending for their routine booster immunisations at 12 months are likely to receive at least 4 vaccines at that same appointment. If another vaccine needs to be administered in the same limb, then it must be given at least 2.5cm apart. The sites at which each vaccine was given should be noted in the individual’s health records.

Healthcare professionals are encouraged to discuss any recent immunisations at the 12-month booster appointment with parents. This is because some infants may receive additional vaccines, such as hepatitis B and BCG, as part of a selective immunisation programme at around 12 months of age, and additional vaccines should not be administered into the same limb as the BCG vaccine for a period of 3 months from administration.

Administering multiple vaccines in one session

Some parents may be concerned about the number of vaccines being administered in one session, particularly at 12 months of age when 4 vaccines are scheduled to be administered. Whilst these concerns are understandable, parents should be reassured by confident and knowledgeable healthcare professionals that the aim of immunisation is to provide protection against harmful diseases at the very earliest opportunity. The Centers for Disease Control and Prevention advise that there are no harmful effects from administering multiple vaccines in one session and there is no evidence to support arguments of overloading the immune system. From the moment a child is born, they are continually being exposed to a huge number of bacteria and viruses on a daily basis that the immune system is able to cope with. Additionally, administering multiple vaccines in one session is a routine occurrence in most countries around the world with no evidence of harmful effects being identified.

Parents who request for their child’s immunisations to be separated should be informed of the potential risks of delaying protection against a disease. Additionally, healthcare professionals are encouraged to identify the reasons for such requests as many parents may be concerned about the number of vaccines administered in one session. Such parents can be reassured that studies have clearly demonstrated that there are no harmful effects of administering more than one vaccine in one session.

Delaying vaccination

Parents should be discouraged from delaying immunisation as this inevitably delays important protection. The immunisation schedule has been designed to ensure optimal protection against diseases that are most common in the very young such as pneumococcal disease, Hib, meningococcal disease and pertussis (whooping cough). These diseases can be life-threatening and it is important for children to receive protection at the earliest possible opportunity.

Administering Bexsero® at the same time as other vaccines

Currently available evidence indicates that Bexsero® can be safely co-administered with MenC and MenACWY conjugate vaccines, and other vaccines including those to be scheduled at the same time (for example pneumococcal and Hib vaccines) without affecting the immune response to either vaccine.

Question 10

Vaccine administration errors

Accepted Answer

Bexsero® administered earlier than 8 weeks of age

The immunisation schedule has been designed to provide early protection against infections that are most dangerous for the very young.

Recommendations for the age at which vaccines should be administered are informed by the age-specific risk for a disease, the risk of complications and the ability to respond to the vaccine. Therefore, vaccines should be administered as closely to the schedule as possible.

In certain circumstances, the first set of primary immunisations (including MenB) can be administered from 6 weeks of age, for example for infants that are due to travel to another country before they reach 8 weeks of age when the primary immunisations are usually given. However, Bexsero® is licensed for use from the age of 8 weeks so if it is administered earlier than this, it should be treated as an ‘off-label’ use of a licensed vaccine and will require a PSD for its supply and administration.

If Bexsero® is inadvertently given prior to 8 weeks of age but the infant is over 6 weeks of age, this should count as a valid dose and does not need to be repeated. Doses given before 6 weeks of age should be discounted and the scheduled infant doses should still be given at 8 and 16 weeks of age.

Inadvertant early administration of second dose

In the event that the second dose of Bexsero® is inadvertently administered earlier than recommended (for example with the 12-week immunisations), infants should be offered an additional dose of vaccine at 16 weeks to ensure protection against meningococcal B disease.

As Bexsero® has been associated with an increase in fever when administered concomitantly with other routine childhood vaccines, infants inadvertently given Bexsero® at 12 weeks should be given liquid paracetamol as recommended for the 8-week or 16-week Bexsero® dose.

For further information, please refer to Adverse reactions commoly associated with the administration of Bexsero® and Using prophylactic infant paracetamol suspension with Bexsero® vaccine.

Missed doses of Bexsero® vaccine

MenB vaccination is offered to children up to their second birthday. Infants who have missed scheduled doses of MenB, or who have not received the recommended number of doses for their age, should be offered the vaccine at the earliest opportunity. These infants should be managed according to the Vaccination of individuals with uncertain or incomplete immunisation status algorithm to ensure they are up to date with all immunisations.

Infants younger than 12 months should receive 2 doses of MenB vaccine, ideally 2 months apart. If the infant does not commence their MenB immunisation course before the age of 10 months, this interval can be reduced to 4 weeks to enable 2 doses of vaccine to be given before their first birthday. These infants should then follow the routine schedule and receive a booster dose in their second year of life. The booster dose is recommended to be given around the time of the first birthday but if primary doses have been given late, a minimum 4-week interval between primary and booster doses should be observed.
Children aged one year to less than 2 years who have never had MenB vaccine should receive 2 doses of vaccine with an 8-week interval between doses.
Children aged one year to less than 2 years who only received one dose of MenB vaccine in their first year of life should receive 2 doses of vaccine in their second year of life. Ideally an 8-week interval should be observed between doses but this interval can be reduced to a minimum of 4 weeks to ensure the doses can be administered before the child’s second birthday, for example, if the first of these 2 doses is not given until the child is 22 months old.

Incomplete dose administered

In the event that less than the recommended dose of Bexsero® is administered, the vaccination will need to be repeated because the dose that the infant received may not be sufficient to evoke a full immune response. Where possible, the dose of Bexsero® should be repeated on the same day as the incomplete dose was administered.

In the event that the additional dose of Bexsero® cannot be administered at the same visit or on the same day, arrangements should be made to administer the replacement dose as soon as possible, in order not to delay protection.

As Bexsero® has been associated with an increase in rates of fever when administered concomitantly with other childhood vaccines, prophylactic paracetamol should be offered with replacement Bexsero® doses if offered at the same time as other vaccines. For further information, please refer to Adverse reactions commonly associated with the administration of Bexsero® and Using prophylactic infant paracetamol suspension with Bexsero® vaccine.

Question 11

Useful links

Accepted Answer

Public Health England. ‘Invasive meningococcal disease (laboratory reports in England): 2014/2015 annual data by epidemiological year’ Health Protection Report 2015: volume 9, issue 38 (viewed on 21 February 2025) ↩
UK Health Security Agency. ‘Meningococcal disease: laboratory-confirmed cases in England 2023 to 2024’ ↩
Mensah AA, Campbell H, Clark SA and others. ‘Outcomes of meningococcal serogroup B disease in children after implementation of routine infant 4CMenB vaccination in England: an active, prospective, national surveillance study’ The Lancet Child and Adolescent Health 2023: volume 7, issue 3, pages 190 to 198 ↩
Parikh S, Andrews N, Beebeejaun K and others. ‘Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study’ The Lancet 2016: volume 3, issue 388, pages 2,775 to 2,782 (viewed on 21 February 2025) ↩
Ladhani S, Andrews N, Parikh S and others. ‘Vaccination of Infants with meningococcal Group B vaccine (4CMenB) in England’ The New England Journal of Medicine 2020: volume 382, pages 309 to 317 (viewed on 21 February 2025) ↩ ↩² ↩³
Gossger N, Snape M, Ly-Mee Y and others. ‘Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial’ The Journal of the American Medical Association 2012: volume 307, issue 6, pages 573 to 582 (viewed on 21 February 2025) ↩
Prymula R, Esposito S, Zuccotti GV and others. ‘A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I)’ Human Vaccines and Immunotherapeutics 2014: volume 10, issue 7, pages 1,993 to 2,004 (viewed on 21 February 2025) ↩ ↩²
ClinicalTrials.gov. ‘Study assessing the effect of medications to prevent fever on Prevenar 13®’ 2014 (viewed on 21 February 2025) ↩

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