Having recently becoming a grandfather to four beautiful healthy babies, and looking at best practices for maintaining their health, I looked into the vaccine schedule for newborns. I was shocked at what I discovered.
One of the vaccines recommended for babies, to be given at 2, 4, and 6 months of age is a product named Bexero. It is a vaccine to protect against Meningococcal group B bacteria.
I downloaded and read the product information leaflet dated July 2017 (along with others for all the recommended vaccines) provided by the NHS, to see if there was any safety concerns regarding using this vaccine on a newborn. To be doubly sure I also downloaded the product package insert (dated May 2018 so supersedes the NHS leaflet) direct from the manufacturer (GlaxoSmithKline).
What I discovered when I compared the two documents shocked me to the core.....
The first line of the NHS PIL (product information leaflet) states: "This medicine is subject to additional monitoring". I thought this strange because surely if a vaccine is to be given to a newborn it would already have been subjected to rigorous safety testing to ensure its suitability. So I then looked at the manufacturers vaccine insert (VI).
I discovered that this product has never been tested for safety on anyone younger than ten years old! In fact the manufacturers VI states "BEXSERO is approved for use in individuals 10 through 25 years of age". IT IS NOT APPROVED BY THE MANUFACTURER FOR USE IN ANYONE YOUNGER THAN TEN YEARS OLD!
So I did some more digging and discovered that there has only been one study carried out on children under ten by the European Medical Agency (EMA), and all it studied was the vaccines ability to produce antibodies in those children. (See here) drugs.com/uk/bexsero.html. The snippet taken from the NHS choices website in the attached photo is a total lie. The vaccine has NEVER BEEN TESTED FOR SAFETY IN CHILDREN UNDER TEN.
I then scrolled further down the NHS PIL and found the following: " Bexsero can be given at the same time as any of the following vaccine components: diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox, and meningococcus C."
Yet in the manufacturers VI it states: "Sufficient data are not available to establish the safety and immunogenicity of concomitant administration of BEXSERO with recommended adolescent vaccines."
So it has NOT been tested for safety when administered with other vaccines, yet it is routinely given to 2, 4, and 6 month old babies at the same time as 8 other vaccines!
Further down the PIL I found a long list of possible side effects affecting more than 1 in 10 recipients: (More than 1 in 10 could mean 9 in ten!)
Fever (≥38ºC) - loss of appetite - tenderness or discomfort at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved) - painful joints - skin rash - sleepiness - feeling irritable - unusual crying - vomiting - diarrhoea - headache.
Also listed were the following side effects that have been reported during marketed use:
Severe swelling of the lips, mouth, throat - difficulty breathing with wheezing or coughing - loss of consciousness and very low blood pressure - Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, - paleness or bluish skin discoloration in young children - Feeling faint or fainting.
Some of the above are concerning but maybe not considered serious, so again I checked the VI to check the incidence of serious adverse events. I discovered:
"(2.1%) participants reported serious adverse events at any time during the study".
That's 1 in every fifty participants experiencing a SERIOUS adverse reaction to the vaccine in clinical trials. And remember these trials were on 10 to 25 year olds, not 2 month old babies, so how will a newborn react..... Once again the information given on the NHS choices website regarding safety is a lie because CLINICAL STUDIES HAVE SHOWN THAT 1 IN EVERY 50 HAS SUFFERED A SERIOUS ADVERSE REACTION.
This vaccine is to provide protection against a disease that only affected 0.0006% of UK inhabitants in 2017, so where is the logic in giving an untested vaccine to babies for a disease that is so rare that 99.9994% of the total population will never be affected by it? (Statistics here) assets.publishing.service.g...
Then in suddenly dawned on me the true meaning of the opening statement of the PIL: "This medicine is subject to additional monitoring". Our babies are being used as unwitting guinea pigs and test subjects to monitor the safety of this vaccine in children under ten years old. Clinical safety trials have never been conducted by anyone else on subjects under ten!
This to me is an abomination. Our precious babies should not be unwitting test subjects, and their health and well-being compromised, purely for the financial benefit of medical professionals and the pharmaceutical industry.
I would be interested in others thoughts.
The documents referred to if you wish to compare them yourself can be found here:
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8 Replies
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Hi Britbuild,
I think it’s very sensible for any parent to consider the pros of the vaccination schedule for infants against the cons, but despite your very knowledgeable and reasoned argument, I am left with the vision of the baby I saw on TV yesterday, with quadri-limb amputations as a result of not having been vaccinated early enough for MenB.
I sincerely doubt that babies are expressly being vaccinated en-masse simply for the benefit of the pharmaceutical industry.
It is of course still a parent’s decision in UK whether to go ahead or not, but I think it’s sensible to point out what can be the quite drastic consequences of deciding against vaccination.
Whilst the consequences of a rare meningitis B infection can be saddening and extremely tragic, it does not excuse the blatant and deliberate misrepresentation of the safety of this vaccine by the UK health authorities. With any medical intervention that carries any kind of risk, informed consent is considered the standard in fulfilling a medical practitioners Hippocratic oath to "first do no harm".
One cannot justify the unashamed deception perpetrated by the NHS in their literature and on their websites, regarding the safety and efficacy of this vaccine, on the premise that it might protect someone, somewhere, sometime. Additionally, how can one give true informed consent to the administration of this vaccine to vulnerable infants, when vital information regarding safety is purposely withheld?
I’ve been doing a bit more digging since my original post, and have discovered information that makes these mendacious practices appear even more unsavoury.
In July 2013 The Joint Committee on Vaccination and Immunisation (JCVI) issued a statement explaining why the Bexero vaccine had been rejected by them for inclusion in the childhood schedule at that time. It explained:
“JCVI convened, in 2010, a meningococcal sub-committee to conduct a comprehensive and detailed assessment of the evidence on the meningococcal B vaccines in development and on the impact and cost effectiveness of a range of potential meningococcal B immunisation strategies.”
The report exposed why the vaccine was rejected:
“JCVI noted that clinical trials show that the antibody responses provided by the primary infant schedule of Bexsero® wane rapidly.” In other words its effectiveness is short lived.
“Data on the persistence of the antibody responses following subsequent boosting and also from primary toddler or adolescent immunisation are more limited.” In plain English, There is even less evidence that it is effective in older children and if booster shots actually work.
But here is the kicker:
“JCVI noted that the efficacy of Bexsero® against disease has not been established.” This one doesn’t need an explanation. It states clearly and categorically that there is zero evidence that the vaccine actually works.
Even the manufacturers VI has the following get out clause:
“BEXSERO may not protect all vaccine recipients. BEXSERO may not provide protection against all meningococcal serogroup B strains.”
So although your assertion that the benefits of this vaccine may outweigh the risks is laudable, unfortunately it is founded upon very little evidence. However, based upon what data is available, it’s probable that the unfortunate child you mentioned may not have been protected had she received the vaccine.
Also, whilst you sincerely doubt that babies are expressly being vaccinated en-masse simply for the benefit of the pharmaceutical industry, I also have my doubts. I sincerely doubt that the JCVI did a complete u-turn on the Bexero vaccine, in the space of just 9 months, without some kind of incentive or pressure from the pharmaceutical industry. If you believe they are in business primarily for the benefit of mankind and not profit, then you are being quite naïve.
The simple fact that the vaccines efficacy is unproven brings into question even more vigorously, the unethical use of our babies as test subjects for vaccine safety, and the blatant deception of the NHS in their literature.
So it took me all of 3 minutes to Google the manufacturer package leaflet, scroll down and read that it clearly states the vaccine you are talking about is in fact designed to be given to individuals 2 months and above.
Even the source you link state this. I don't understand the point of your deliberately inflammatory post
I posted links to both the product information leaflet (the one given to recipients) and the Manufacturers Package Insert (the one actually produced by the manufacturer) in my original post. They are two different documents, produced by two different entities. If you look through the PIL you will note that it states that this vaccine can be given to babies aged 2 months. It does not however mention that it is safe to do so and it doesn't give any information on any safety testing that has been carried out on 2 month old infants.
It does however state at the very top: "This medicine is subject to additional monitoring. This will allow quick identification of new safety information."
So that to me means that the babies being given this vaccine are the test subjects to monitor its safety.
But it appears you missed the important document - the one produced by the people who make this vaccine and have carried out (somewhat limited) safety tests. You can read that here: gsksource.com/pharma/conten...
Let me point out a few salient sections.
6.1 Clinical Trials Experience.
You will note that ALL clinical trials were carried out exclusively on people aged 10 and above. There are no trials listed for any age group younger than this.
7 DRUG INTERACTIONS
"Sufficient data are not available to establish the safety and immunogenicity of concomitant administration of BEXSERO with recommended adolescent vaccines." Yet this vaccine is routinely given with other childhood vaccines.
But here's the important one.
8.4 Pediatric Use
"Safety and effectiveness of BEXSERO have not been established in children younger than 10 years."
So the manufacturers own package insert, not some document cobbled together by the EMA or JCVI, states unequivocally that the product has not been tested for safety or efficacy in children under ten. And this document is dated May 2018, so is very current.
You appear upset that my (in your words) "deliberately inflammatory post", is alerting parents to the fact that their babies are being used as guinea pigs. Why are you so upset that I am warning people of the dangers and inefficiency of this vaccine?
Perhaps you ought to direct you angst toward Professor Andrew Pollard, the new head of the JCVI. This is the person who reversed the JCVI's previous decision to reject Bexero, and added it to the childhood schedule. This is also the person who is ; "named in patents in the field of meningococcal vaccines” and was "contracted in continuing research relating to Bexsero". So no conflict of interest there then! And could it be that this "continuing research" is related to discovering how safe this vaccine is in our two month old babies?
When one starts to dig one finds the rabbit holes go very deep.
This "blatant deception" you keep on saying is a massive red herring. If it was a deception you would never know about it.
To read the research, data and patient information leaflets is one thing. Understanding the research, data and patient information is another thing entirely, and is something that is abundantly evident here.
You have clearly dug and dug and dug until you have found what you want to hear and what you have interpreted as something you want to hear.
Put it this way - we have patients who demand homeopathic remedies as alternatives as ibuprofen because they have scared themselves to death after reading the PILs and bringing forth stuff like you do.
As Med Z says you don't understand the information you are presented with and coming to conclusions that do not support the evidence or facts - you are taking in only what you want to know, then challenge the people who do.
It is quite clear that you simply do not understand the information given to you.
It seems my post is stirring the pot a little as it appears that you have joined this forum specifically to reply to my findings. It is also clear that you are making a lot of assumptions regarding my ability to interpret the data. You state that it is "abundantly evident" that I do not understand the research data and patient information. It is not difficult for anyone to understand a statement that reads;
"Safety and effectiveness of BEXSERO have not been established in children younger than 10 years." and;
“JCVI noted that the efficacy of BEXERO® against disease has not been established.”
It is not a case of trying to find something I want to hear. It is a case of letting others know that the EMA, along with the NHS, are not being completely honest with parents regarding the safety and efficacy of this vaccine in their babies.
The conclusions that I have presented are absolutely supported by the evidence and facts. This you would see for yourself if you bothered to read the manufacturers package insert provided in the link above, instead of jumping to erroneous conclusions about my ability to read, understand, and interpret data. This appears to be your only rebuttal to the evidence I have presented, and is a classic case of 'if I can't dispute the message I will attempt to discredit the messenger'.
Just to let you know, I have been researching vaccines comprehensively for over 5 years. I have read (and completely understood) countless scientific peer reviewed studies, scientific/medical articles, and manufacturers safety studies during this time. I am currently writing a book about vaccines based upon my intensive research. In fact I probably know more about vaccine efficacy and safety than you do. So please don't jump to conclusions about my ability to understand data. I was simply putting my findings into layman's terms for the consumption of the public.
And whilst we are on the subject of vaccine recommendations and safety, there is another concern you may wish to address. Why does the NHS universally recommend the flu vaccine to expectant mothers, when the manufacturers product insert on every flu vaccine available states (or similar);
8.1
Pregnancy
Risk Summary
"There are insufficient data on (**this vaccine**) in pregnant women to inform vaccine-associated risks." And;
8.2
Lactation
Risk Summary
"It is not known whether (**this vaccine**) is excreted in human milk. Data are
not available to assess the effects of (**this vaccine**) on the breastfed infant or
on milk production/excretion." Many also state;
"this vaccine should be used during pregnancy only if clearly needed."
It does also say though;
"There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to (**this vaccine**) during pregnancy."
So maybe you might want to explain to all of the expectant mums out there who have been recommended flu vaccines, that they too are being experimented upon.
You can check them all if you wish (section 8.1 and 8.2 on them all), but make sure you check the authentic manufacturers insert, not the PIL as important information is always conveniently omitted from that document.
You clearly have absolutely no idea what you're talking about. Cutting and pasting removes the context for the fact and you are blindly interpreting as a consequence. You are digging very hard to find the dangers that you want.
You've asked for opinions. I'm qualified enough to tell you not to worry and stop looking for collusion and deception, there isn't any.
As for your flu question - the answer is also in the text you posted - but you don't actually want to read that part. It's a risk calculation based on the probability vs the benefits. You don't want to hear that and have latched onto what you see as the dangers! The context is missing.
I deliberately left out one important snippet but I cannot be bothered to wait for your reply.
As proof that you clearly don't know what you are talking about - you are cutting and pasting American FDA rules NOT UK rules!
If you wish to have a valid issue at least Google UK only so that you get UK rules.
BEXSERO is approved for use in children, in the UK!
Furthermore you claim that BEXSERO has never been tested in children, claiming the NHS website is a lie yet the link you give drugs.com/uk/bexsero.html clearly shows that it has!!
With respect you really, really don't know what you're talking about and don't want to know the truth but rather are obsessed with a need to create your own story, no matter how false that story is.
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The letter to the Times states ' "business as usual won't do", 
Why can't I buy canesten for thrush? Surely denying this medicine to over 60s is ageist! 
Deep Brain Stimulation!!
Mr A.M.Savage