by Christina England
Health Impact News
In 2016, we published an article on the dangers of the meningitis B vaccination, Bexsero, titled, Are Ineffective New Meningitis B Vaccines Causing Harm to Children? [1]
At the time of publication, according to the FDA product information leaflet [2], the vaccine had in fact only been approved for children over the age of ten.
Despite, this fact however, in the UK, the meningitis B vaccine Bexsero was being administered to infants as young as 2 months [3], despite the fact that we could find no evidence to support that this vaccine was safe to be administered to babies.
In our previous article, we stated that:
“In the UK, Bexsero is the main vaccination being recommended for babies between the ages of two and six months, a vaccine that, according to the manufacturers vaccine insert, has only been approved for individuals from the ages of 10 through to 25.”
To support our argument, we published the following screenshot from the FDA website:
[4]
We continued that:
“What is even more alarming is the fact that the manufacturer has stated that the safety and effectiveness of this vaccine have not been established in children under 10 years of age.”
Once again, to prove that this was the information being provided by the FDA, we published the following screenshot:
[5]
In fact, the Centers for Disease Control and Prevention [6] (CDC), now provide similar information to the FDA. In 2016, they stated:
“Serogroup B Meningococcal Vaccines:
Two serogroup B meningococcal vaccines — Bexsero® and Trumenba® — have been licensed by the Food and Drug Administration (FDA).
These vaccines are recommended routinely for people 10 years or older who are at increased risk for serogroup B meningococcal infections, including:
- People at risk because of a serogroup B meningococcal disease outbreak
- Anyone whose spleen is damaged or has been removed
- Anyone with a rare immune system condition called “persistent complement component deficiency”
- Anyone taking a drug called eculizumab (also called Soliris®)
- Microbiologists who routinely work with isolates of N. meningitidis
These vaccines may also be given to anyone 16 through 23 years old to provide short term protection against most strains of serogroup B meningococcal disease; 16 through 18 years are the preferred ages for vaccination.”
Since publishing the article, it has been brought to our attention that there are in fact two product information leaflets on the same vaccination.
However, what is different about the second product information leaflet, published on January 14, 2015, by the European Medical Agency [7] (EMA) is that the information that it provides, is the polar opposite, of the information provided by the FDA.
Who is Correct Regarding the Safety of this Vaccine for Children: The FDA or The EMA?
Due to the fact that the information provided by both agencies is conflicting, how are parents supposed to know which agency is providing the correct information?
For example, in contrast to the FDA, the EMA has confirmed that not only is Bexsero safe and effective, but that it should be given to all babies from the age of eight weeks.
They stated that:
“The first dose should be given at 2 months of age. The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available.
In case of delay, the booster should not be given later than 24 months.”
Whereas, the FDA clearly stated that the safety and effectiveness of Bexsero had not been established in children under the age of 10 years, the EMA has stated the complete opposite:
“The safety of Bexsero was evaluated in 14 studies including 10 randomised controlled clinical trials with 8776 subjects (from 2 months of age) who received at least one dose of Bexsero. Among Bexsero recipients, 5849 were infants and children (less than 2 years of age), 250 were children (2 to 10 years of age) and 2677 were adolescents and adults. Of the subjects who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life. Data for a further 207 children exposed to Bexsero in a subsequent study have additionally been evaluated.”
The EMA continued:
“In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone. Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines. When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials.
When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
In adolescents and adults, the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.”
Confused by the conflicting information being offered to parents, Health Impact News turned to the manufacturer of the vaccine, GlaxoSmithKline, for guidance.
Once again their information published on the GlaxoSmithKline website, July 2017 [8], mirrored information published by the FDA. They stated:
“BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.
Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.”
As you can clearly see, the information that is being provided by GlaxoSmithKline, is exactly the same as the information being provided by the FDA.
This being the case, we must ask:
Is the UK government conducting clinical trials on infants, and if they are, then are parents aware of this fact?
All the information that we have discovered during our investigation has indicated that the meningitis B vaccine Bexsero should only be given to children aged 10 – 25 years. Other than the EMA, no agency has provided alternate information.
In a final attempt to find any other alternative view on this we turned to the Joint Committee for Vaccination and Immunization (JCVI).
JCVI Recommend Paracetamol as Bexsero Can Cause an Increased Risk of Fever
The JCVI are an organization that advises the UK health departments on immunization. In 2014, they published a paper titled, JCVI position statement on use of Bexsero® meningococcal B vaccine in the UK [9].
They wrote:
“This statement sets out the conclusions of the JCVI regarding its deliberations on the cost-effectiveness of using serogroup B meningococcal (MenB) vaccine in the UK, both routinely in infants and/or adolescents and in at risk groups. This statement follows extensive discussion, which the Committee believes was necessary to ensure the most robust conclusion possible was reached. The Committee is of the opinion that its deliberations have
taken into account the views and comments received, and are based on the most up to date and complete scientific evidence on MenB disease and the MenB vaccine Bexsero®. The health economic analyses undertaken comply with the methodology of National Institute of Health and Care Excellence (NICE) and appropriate NICE guidance.” (own emphasis)
Sadly, their evidence appeared to be more about whether or not the vaccine was cost effective, than whether the vaccine was actually safe or not.
However, they did state that:
“JCVI considered safety data from clinical trials totalling over 6000 participants, and reviewed the European Medicines Agency’s (EMA) considerations of this data. As with any new vaccine or medicine, knowledge of the safety profile of the vaccine is limited to the size of the clinical trials, however the Committee in October 2013 agreed these trials suggested there would be benefits to the vaccinated population.”
Although, they continued their statement with the following extremely worrying piece of information:
“Data from clinical trials suggest that the frequency of fever following routine infant immunisations would be expected to substantially increase if Bexsero® was given with other routine infant immunisations however, concomitant administration of prophylactic paracetamol reduced fever rates without significantly reducing immunogenicity, in contrast to a study of concomitant paracetamol with routine infant immunisations (excluding Bexsero®). Data were too limited to identify rare adverse reactions to the vaccine, however the Committee agreed that the infrastructure and expertise available in the UK would allow the acceptability and safety of the vaccine to be assessed.” (own emphasis)
And if this statement was not alarming enough, they continued by adding that:
“JCVI noted evidence of an increased risk of fever when Bexsero® was administered with other childhood immunisations in the UK schedule. Given this, and concerns of the Committee that this could lead to an increase in fever requiring medical attention, or lead to lower uptake of subsequent vaccinations it was agreed there would be a need to educate parents, and healthcare professionals on the potential reactogenicity of provision of Bexsero® concomitantly with other infant vaccinations. Good communications would reduce the impact of fever on the health service, and provision of prophylactic paracetamol at the time or shortly after vaccination, with a further two doses every four to six hours thereafter should reduce the likelihood or intensity of fever, without diminishing the immune response.” (own emphasis)
In other words, the JCVI recognize the fact that this vaccination has the potential to cause a fever severe enough to warrant medical attention, but it is OK because parents can be educated to give their children regular doses of paracetamol, which incidentally, according to the National Health Service, can cause liver failure [10].
Learn more about the dangers of paracetamol (acetaminophen) [11].
Interestingly, it appears that the chairman of the JCVI, which is the British equivalent of the ACIP (Advisory Committee on Immunization Practices), Prof Andrew J Pollard helped in the manufactuting of Bexsero.
This was reported by Age of Autism who wrote [12]:
“Prof Andrew J Pollard spoke this September at an event sponsored by vaccine manufacturer GlaxoSmithKline “Evening of Evidence/Vaccination Science to Policy: Introduction of new vaccines to the UK vaccine schedule with limited evidence of efficacy (sic): Meningococcal Group B and maternal pertussis vaccination [13]“.
Prof Pollard spoke on the subject of Meningitis B vaccine which he helped to develop and latterly seems to have superintended the process of having it added to the United Kingdom vaccine schedule as chairman of the JCVI – his talk was entitled: “JCVI decision-making process informing the recommendation for the introduction of Bexsero to the UK vaccination schedule”.
Bexsero vaccine was developed by Novartis but their vaccine division was acquired by GSK earlier this year, following the approval of Bexsero vaccine by the JCVI (negotiations began within days of the JCVI approval).
A deputy chair of the JCVI, Dr Andrew Riordan, spoke at the same meeting on the subject: “Evidence considered by the JCVI to recommend antenatal pertussis vaccination in the UK”. GSK also manufacture Boostrix – in fact a pertussis, tetanus and diphtheria vaccine – which is the product currently given to pregnant women in the UK, [14] which also has an aluminium adjuvant.”
With this information in mind, Health Impact News would like to know what is really behind the UK’s decision to give this vaccination to infants as young as eight weeks of age, and should parents be warned that it has not been approved for children under the age of 10 years old?
Comment on this article at VaccineImpact.com. [15]