This article addresses the Bexsero (men b) vaccine, manufactured by GSK (formerly GlaxoSmithKline) given in Ireland and the illnesses that it aims to protect against. It outlines the ingredients, the possible risks, studies in support of its use and those highlighting concerns.  

Once you understand the risk associated with each disease and compare it to the risks and contraindications associated with the vaccine, you can then decide whether or not to vaccinate your baby.  Read this information carefully before making this important decision. 

Health Freedom Ireland (HFI) encourages you to become fully informed about vaccines and the associated illnesses so that you can give informed consent if you choose to vaccinate yourself or your child(ren). This information is for educational purposes only and is not intended as medical advice. HFI is simply bringing this information to you – we neither recommend nor advise against vaccination.

Summary

• The Bexsero (men b) vaccine contains 20 times the amount of aluminium considered safe by the US Food and Drug Administration (FDA) to be administered via an IV.  Aluminium is classed as a neurotoxin.
• According to the manufacturer’s leaflet 6,837 babies under the age of two received the vaccine in clinical trials. As a result, it is not possible to know what side effects would be seen with larger numbers.
• Vaccination is not mandatory in Ireland and is not necessary to attend school or creche.
• Those allergic to ingredients in the vaccine are advised not to take the vaccine.  However, this vaccine is given at 2, 4 and 12 months of age, while your baby’s immune system is still developing.  You cannot know whether your baby is allergic to any of the ingredients. 
• As of 23rd September, 2023, there were 149,295 adverse events reported on the World Health Organisation VigiAccess database for meningococcal vaccines including Bexsero (men b).

Diseases it aims to protect against

The Bexsero vaccine aims to protect your baby against Meningococcal B. Read our article on Meningococcal B for more information.

When is it given? 

The Bexsero (men b) vaccine is given to babies in Ireland at 2, 4 and 12 months of age.  

What is in this vaccine?

The Bexsero Vaccine Summary of Product Characteristics section 2 outlines ingredients in the vaccine as follows. This list excludes the vaccine antigens:

Is the Bexsero (men b) vaccine safe?

To begin to answer the question of whether vaccines are safe, one needs to delve a little into the history of vaccines. In the US, after establishing that vaccines were “unavoidably unsafe” the National Childhood Vaccine Injury Act of 1986 granted immunity from liability to all vaccine manufacturers and established the Vaccine Injury Compensation Program (VICP). No other product or medicine has ever enjoyed this level of immunity. In America, anyone sustaining an injury from a vaccine must seek redress directly from the VICP. See the Compensation Scheme section below for the legal situation in Ireland.

These favourable market conditions have led to a booming vaccine market currently worth in excess of $60bn and projected to grow to $125bn by 2028. Government lobbying, large scale funding and advertising spend means that media, influential institutions and medical journals cannot remain impartial. In addition, large portions of regulatory agencies’ budgets are funded by the industry they are supposed to regulate:

Although most vaccines are for children and newborns, they undergo much shorter clinical trials and safety review periods than regular drugs. Standard drugs, such as Lipitor (for cholesterol) and Eliquis (a blood thinner), that are not immune to liability, are tested for several years. Vaccines on the other hand are tested for a very short timeframe. The Guideline on clinical evaluation of vaccines published by the European Medicines Agency (EMA) in Jan 2023 states the following:

“Some additional considerations for the assessment of vaccine safety in clinical trials follows. Since most adverse reactions to vaccines occur within the first few days after each dose, it is common practise that solicited local and systemic symptoms are collected for approximately 5-7 days after each dose. A longer post-dose period of collection of solicited symptoms may be applicable for replication-competent live vaccines (e.g. 10-14 days or sometimes more), depending on what is known about the duration of shedding of the vaccine (s).”

The double blind placebo control study (with an inert placebo) which is the gold standard of drug safety testing required for all other drugs, is not required for vaccines. Instead, other vaccines or biologically reactive solutions in place of placebos are used which obscure safety issues with the new vaccine being tested. The EMA confirms in their guideline on vaccine trials (section 5.2) that other licenced vaccines can be used in place of a placebo.  

“If a placebo control is considered inappropriate (e.g. because investigators and/or participants/care-givers would reject the possibility of randomisation to multiple placebo injections), a licensed vaccine without an effect on the disease to be prevented by the candidate vaccine could be administered to the control group.”

Once the vaccine is launched on the market it is considered unethical to leave any child in the “control group” unvaccinated, so all controls are vaccinated with the latest vaccine. This practice renders comparison of the longer term health outcomes of vaccinated and unvaccinated population essentially impossible.

In relation to the Bexsero (men b) vaccine specifically, 6,837 babies under the age of two received the vaccine during the trials according to the manufacturers leaflet. 3,285 of these received a booster when they were a year old and as a result, it is not possible to know what side effects would be seen with a larger sample size. In terms of study length for babies, the leaflet mentions a study where approximately 300 infants were tested to see antibody levels one year after their booster dose at 12 months and another study of 68 infants a year after they had a second dose of the vaccine at 13 or 15 months. It is not clear if the safety was monitored for the same length of time. It is not possible to assess any long term effects from studies lasting one year.

Vaccine side effects

The Health Services Executive (HSE) in Ireland states:

The vaccines used in Ireland are safe. All medicines can cause side effects, but with vaccines these are usually mild, like a sore arm or leg or a slight fever. Serious side effects to vaccines are extremely rare.

The Centre for Disease Control (CDC) in the US says the following:

“As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.”

The Patient Information Leaflet (PIL) for the Bexsero (men b) vaccine lists all side effects observed for children during clinical trials in section 4:

Worldwide voluntary reports of side effects

What Parents Say

“Advice to new parents- research vaccines from sources not receiving payments for administering vaccines as much as you likely researched baby products you purchased. What I wish I had known – the ingredients. ALL the potential side effects (not just the 5 the HSE informed me about), the frequency at which side effects happen”

More from parents

There are a number of systems that healthcare practitioners and the general public can use to report any adverse effects they may have with any vaccine once they have been launched on the market (post marketing adverse events).

• VigiAccess – World Health Organisation platform 
• VAERS – US system managed by the Centre for Disease Control (CDC)
• Eudravigilance – EU system managed by the European Medicines Agency (EMA)

Side effects to vaccines and other drugs in Ireland can be reported to the HPRA which is in turn added to the Eudravigilance database. The systems listed above are all passive reporting systems relying on voluntary rather than mandatory reporting.

The US government funded a study – carried out by Harvard Pilgrim Health Care – that found that less than 1% of adverse reactions are reported to VAERS. In this study, data on vaccines was collected over 3 years on 1.4 million doses given to 376,452 individuals. The study cost over 1 million dollars. Another study on the Italian reporting system, which is also a passive system, found a huge disparity in the numbers of Adverse Effects Following Immunisation (AEFIs) between passive and active reporting systems and said that “passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs “.

As of 23rd September, 2023, there were 149,295 adverse events reported on the World Health Organisation VigiAccess database for meningococcal vaccines including Bexsero (men B), and Menjugate (men C), and 2,131 for hib/meningococcal vaccine including Menitorix (men C).

   

Compensation Schemes

In the US, the National Childhood Vaccine Injury Act of 1986 granted immunity from liability for all vaccine manufacturers and established the Vaccine Injury Compensation Program (VICP).  This overview of a number of such schemes published on oireachtas.ie points out that they “require standards of proof showing a causal link between vaccination and injury, although this has often led to overly strict standards of proof”. At the start of 2023, the US scheme had paid out in excess of $4.5 billion in childhood vaccine injury claims. A similar scheme in the UK paid out €86 million between 1979 and 2019. This is despite the fact that the UK scheme requires that claimants are severely disabled and caps awards at £120,000. Since the scheme began in 1979 until May 2017, 79% of claims were rejected based on the claimants’ inability to prove causation. 

Although there are numerous problems with VICPs, depending on how they are designed, as discussed in the Oireachtas overview of VICPs, they should in theory make it more affordable and easier for parents whose child has been injured or killed by vaccines to be compensated as it is not normally required to pay legal fees. A detailed review of the different schemes carried by the Health Research Board (HRB) in Ireland sums it up as follows:

“The purpose of compensation schemes is to provide an alternative option to civil litigation. This is achieved by lessening the stringency around the standard of proof; crucially however, the compensation on offer is typically available more quickly, but the amount is usually lower than what a vaccine-injured individual may receive through litigation.”

However, there is no such scheme in Ireland at present. This is the case even though the Oireachtas Joint Committee on Health and Children recommended that a vaccine damage compensation scheme be set up at the earliest possible date in 2001 according to the HRB. The Oireachtas overview which was published in April 2021 notes that the issue has taken on increased significance now due to the fact that the manufacturers of the covid vaccines are being given “legal indemnity through purchase agreements which means that they cannot be pursued for compensation for vaccine-related harm”. The HRB review, says the urgency in introducing a VICP scheme is increasing since claims are being taken against the Minister for Health, the HSE and GlaxoSmithKline by individuals claiming that they developed narcolepsy after getting the H1N1 (swine flu) vaccine.  According to the review, this will result in exposure of the State to a large number of claims. 

The lack of a VICP scheme in Ireland means that the only avenue open to parents is taking legal action against the state. The HRB review points out the problems with this: 

“However, a more strict form of causation applies in tort law, so mounting a successful case is more difficult and often more time-consuming and costly, restricting access to litigation to those with adequate resources.”

Proving causation is also hampered by the fact that adverse reactions listed in manufacturers leaflets are not accepted as causing the reaction when it comes to getting compensation. This is evident given that claimants have to prove that their child’s adverse reaction was due to the vaccine even with the VICP schemes which should have a lower standard of proof.

How serious are these diseases?

In prosperous first-world countries like Ireland, where there is clean water and sanitation, diseases being vaccinated against are rarely serious anymore. The introduction of antibiotics and other treatments is also a factor. The graph below depicts the mortality trajectory of four diseases; diphtheria, pertussis, scarlet fever and measles in Ireland since the beginning of the twentieth century. In the three vaccine diseases (diphtheria, pertussis, measles) the decline was evident before the vaccine was introduced. Scarlet fever declined from being a fatal disease to one that is generally a mild infection despite the fact that there was no vaccine for it. This highlights the impact of improvement in social conditions on disease outcomes.

According to Our World In Data, poor sanitation is a leading risk factor for infectious diseases. This was highlighted in the Irish CSO annual reports also. For example, the 1867 report (on page 18), recorded a marked decrease in death from disease epidemics after sanitation measures were implemented:

“The benefits resulting from sanitary improvements were well illustrated in the condition of the Milltown Malbay District, Ennistimon Union, which afforded a striking contrast when compared with Mullingar. The Registrar of Milltown Malbay recorded 70 births against 30 deaths, and made the following observations :-
“Dependent on its improved sanitary condition; my district enjoys an immunity from disease epidemic or endemic. Nothing can be more marked than the difference betwixt it and the preceding quarters of the same season when unhappily less preventive measures existed”.

Disease Vs Vaccine Risk Profile

Using CSO mortality data, the disease risk profile for pneumococcal disease is outlined alongside the risk of side effects listed on the latest available Bexsero (men b) Patient Information Leaflet. The Patient Information Leaflet includes side effects from the trials and reports after the vaccine rollout (post-marketing surveillance). It is worth bearing in mind that side effects may be significantly underreported in passive reporting systems like VigiAccess as discussed above – this means that the rates of vaccine side effects below could be many times higher. Read our article on meningococcal b for more information on the disease itself.

Can my child attend creche/school if not vaccinated?

Vaccines are not required for childcare or school in Ireland. The Citizens Information site states:

“The consent of parents is required for vaccinations for children and young people up to the age of 16. Vaccination is not compulsory, but is strongly advised by the Department of Health.” 

Some private creches may ask about vaccines but are not permitted to ask for medical records. Delaying the vaccine until the child is due to start creche is also an option.

Vaccine Studies

As outlined above (see the Is the Bexsero Vaccine Safe section), the longest trials listed in the manufacturers leaflet lasted just one year. Drug trials of this nature should be carried out free from any conflicts of interest with the object under scrutiny.  Unfortunately, many of the studies in support of the vaccine listed below do not comply with industry ethics in this regard. There are no longer term studies included in the leaflets. 

There does not appear to be any studies that measure the clinical efficacy of the meningococcal vaccines. The Advisory Committee on Immunization Practices (ACIP) in the US votes on whether or not vaccines should be approved and added to the schedule. Their recommendations on meningococcal vaccination, states that because incidence of meningococcal disease is so low the vaccine trials do not have to show they can prevent disease. They can just look at immune responses and infer from this whether the vaccine would actually prevent disease in an individual: 

“Because of the low incidence of meningococcal disease in the United States, vaccine efficacy estimates supporting U.S. licensure of the current meningococcal vaccines are based on demonstration of specific immune responses (e.g., immune correlate of protection through serum bactericidal activity [SBA]) and not direct evidence of clinical effectiveness).”. 

This means vaccines could be added to the schedule without proving that they prevent disease in a real world scenario.

Studies that support the Bexsero (men b) vaccine

Study by company acquired by vaccine manufacturer claim bacterial meningitis is 100% vaccine preventable

Bexsero® chronicle

This article mentions the fact that trials have shown that recipients of the vaccine produce antibodies to the different meningitis strains. They infer from this that the vaccine is effective in preventing the disease..

“The efficacy of Bexsero has not been evaluated through clinical trials. Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens.”

It goes on to conclude that bacterial meningitis is 100% vaccine preventable:

“Today, with a full spectrum armory against all five serogroups, bacterial meningitis is a 100% vaccine preventable disease; the next big challenge is to make these existing and new vaccines broadly available to populations at risk via strong political will and genuine and widespread public awareness campaigns.“

Both authors work for Novartis – a company that GSK (who manufactures Bexsero) had begun acquiring before this paper was published.

Product review finds that vaccine provides excellent immunogenicity

Product review on the IMD serogroup B vaccine Bexsero®

Similar to the study above, this one states that efficacy trials are not feasible due to the low incidence of Invasive Meningococcal Disease (IMD) but they state that it provides excellent immunogenicity:

“Bexsero® is a multicomponent vaccine composed of four major proteins of Neisseria meningitidis: the fHbp, NHBA, NadA and PorA. This vaccine was licensed against invasive meningococcal disease (IMD) due to serogroup B isolates. When administered alone, Bexsero® showed a safety profile similar to other childhood vaccines. It provides an excellent immunogenicity but that requires booster doses in infants and young children.”

The paper mentions that the vaccine does not seem to affect the carriage of the meningococci bacterium responsible for meningococcal disease. (According to Meningitis Now – many people carry the bacterium in their nose and throat which is harmless in most people. In a minority of people it leads to invasive disease.)

“The lack of impact of the vaccine on acquisition of carriage of serogroup B meningococci and the need to estimate the effective duration of protection in childhood remain to be solved. However, the observational data now available showing real-world efficacy of the vaccine in England, Portugal, and Italy, [87, 132, 133] are also showing an impact of reducing the incidence of IMD due to serogroup W.”

The two authors reported collaborations funded by GSK and a patent “Bexsero and serogroup X” issued with GSK.

Review of the clinical experience with Bexsero shows reduction in disease

Clinical experience with the meningococcal B vaccine, Bexsero®: Prospects for reducing the burden of meningococcal serogroup B disease

“In 2013, Bexsero® became the first broad-coverage vaccine to be licensed for active immunisation against MenB disease. Bexsero is now licensed in more than 35 countries worldwide for varying age groups, including the EU, Australia, Brazil, Canada, Chile, Uruguay and the USA.

The safety and tolerability profile of Bexsero exhibited during the clinical development programme was considered acceptable by regulatory authorities. Recent clinical experience from vaccination campaigns in populations with both active and passive safety reporting has provided valuable additional data.”

The lead author is an employee of the vaccine manufacturer GSK. He was employed by Novartis – a company that GSK had begun acquiring before this paper was published. The second author has received support from Novartis and GSK including honoraria, grants and travel assistance for conferences. 

Studies expressing concern about the Bexsero (men b) vaccine

Hungarian paper raises concern about cost of Bexsero vaccine and the fact that the clinical effectiveness has not been proven

Bexsero, a novel vaccine against meningococcus

This paper which was published 5 months after Bexsero was rolled out nationally in the UK states that the clinical effectiveness has not been proven. They recommend postponing guidelines in Hungary to introduce it until they have more information on its benefits and risks.

“Based on immunological evidence, it is expected that Bexsero provides protection against this rare but very serious infection. However, the vaccine is extremely expensive, the clinical effectiveness has not yet been proven and it frequently causes fever, especially in infants where the vaccine is most needed. According to the opinion of the authors, the formulation of a Hungarian guideline concerning the application of Bexsero should be postponed until the accumulating international experience makes it possible to better judge the vaccine’s benefits, risks and cost-effectiveness.” 

Analysis prior to introduction of Bexsero found incidence of Men B to be rare in Ontario and that 70% of infants would not be protected by vaccine

Epidemiology of serogroup B invasive meningococcal disease in Ontario, Canada, 2000 to 2010

In this analysis of Meningitis B, the authors who called it a rare disease reported that there were a total of 259 cases of meningitis B in total between 2000 and 2010 in Ontario. This was 0.11 per 100,000 in 2010 – see figure 1. 

They pointed out that more than 70% of cases occurred in babies under 6 months and these would be unlikely to be protected. They referred to a trial of the novel MenB vaccine in which three vaccines were needed to achieve immunogenicity. (The Bexsero vaccine is frequently referred to as a 4CMenB vaccine in the literature).

“As noted in our results, approximately 70% of our infant cases occurred among infants under 6 months of age and these cases may not be vaccine preventable depending on age at vaccination and duration of time to mount an immune response. In a phase IIb clinical trial, Gossger and co-authors [15], found that a schedule of three doses of Novartis’ novel multicomponent meningococcal B vaccine (4CMenB) given to infants at 2, 4, and 6 months of age, and in an accelerated schedule at 2, 3, and 4 months of age were necessary to achieve optimal immunogenicity. This would suggest that disease in infants less than 6 months of age, using a 2, 4, and 6 month schedule, which is typical in Canada, may not be vaccine preventable.”

They go on to conclude:

“If we assume that all infant cases would be preventable by vaccination, we would need to vaccinate between 33,784 and 38,610 infants to prevent one case of disease.”

From the above it is clear that the incidence of Men B is very low. A paper that investigated a prolonged outbreak of invasive meningococcal disease in an Irish Traveller family between 2010 and 2013 states that the incidence of the disease was 1.99 per 100,000 in 2011. It also notes that the figures in Ireland “represents a decrease of 86% from 14.8 per 100,000 population reported in 1999”. This decrease was not due to the vaccine as it was not introduced until 2016. Interestingly the authors of the paper concerning the outbreak in Ireland said that “the most likely risk factor identified for this ongoing outbreak was overcrowding”. More recent Irish statistics show that there were 0.6 cases per 100,000 in 2022. It is also likely that those most likely to be affected by meningitis B would be too young to be fully vaccinated against the disease as it is given at 2, 4 and 12 months in Ireland. Therefore parents need to weigh up whether this vaccine makes sense for their baby.

Survey of German paediatricians reveals a number of concerns with the introduction of the Meningitis B vaccine Bexsero

Survey of pediatricians in Germany reveals important challenges for possible implementation of meningococcal B vaccination

This survey of doctors in Germany reveals a number of concerns about the introduction of the Meningitis B vaccine:

• From the above, 23% of respondents believed that the disease is too rare. This is a valid concern as we saw from the Ontario figures above. Another paper looking at the figures in Ontario makes the following statement on the burden of disease:

“Extrapolating from data in the Ontario study cited above, if 4CMenB prevents 70% of IMD in children younger than 12 months of age, practitioners would have to vaccinate more than 38,000 children to prevent one case. However, if three doses administered at two, four and six months of age are required for protection, infants younger than six months of age will remain unprotected; therefore, this number increases to more than 141,000[13] (and approximately 10 to 20 times that number to prevent one death).” 

• 47% of the doctors believed that the data on rare adverse events was insufficient and almost 16% felt that vaccination causes too many adverse reactions. A paper on post marketing surveillance in Italy, reported the following on Adverse Events Following Immunization (AEFIs):“A total of 13/31 (41.9%) serious AEFIs classified as ‘consistent causal association’ were reported after the first dose of 4cMenB”They also warn that this could be a much higher number:“Because of spontaneous reporting surveillance system are badly affected by underreporting, the impact of the experience of serious AEFIS in vaccination compliance could be, in principle, very notable and requires specific studies on large population.”Kawasaki disease, febrile seizures and seizures were identified by European Medicines Agency (EMA) as potential safety concerns based on clinical trial data. As a result they required a post-authorisation safety study.  There were 9 cases of Kawasaki disease in total – however they could not determine whether this was associated with the Bexsero vaccine (4CMenB) as it was given at the same time as other vaccines in the National Immunisation Programme (NIP) for the UK:
  “The majority of 4CMenB is given on the same day as other vaccinations within the NIP. 4CMenB-containing vaccination is associated with an increased risk of seizures and febrile seizures but it is not possible to attribute the finding specifically to one vaccination type. Increased risks of seizures and febrile seizures have been reported by some previous studies of infant vaccination.
  The study demonstrates that Kawasaki disease is rare after 4CMenB-containing vaccination. The small number of cases did not allow us to draw any conclusion concerning the association between 4CMenB-containing vaccination and Kawasaki disease.”

The following survey question further outlines the concerns of the doctors:

Further resources

Join the parents support group to continue the discussion and learn from the experience of others.

Health Freedom Ireland:

Health Freedom Ireland Meningococcal B

Other:

Health Service Executive (HSE) Childhood Immunisation Schedule
Health Service Executive (HSE) History of Vaccines
Medicines.ie Infanrix Bexsero (men b) Patient Information Leaflet 
US Food and Drug Administration (FDA) Package Insert for Bexsero (men b) vaccine
European Medicines Agency (EMA) Bexsero
HSE Diseases