Every once in a while, an article appears that is so blatantly biased – so obviously just printed directly from a press release – it needs to be highlighted. There will be many credulous people out there – health professionals amongst them – who will look at the title and think they know the story. But let’s look through this piece of medical marshmallow fluff and see where this article has gone so badly wrong.
There you have the title. And if you were to just read that much, as many people do, you would be under the impression that a REAL study was done which found REAL results showing that children were protected from influenza whether they got an injected vaccine or the live-virus nasal spray option. Nothing could be further from the truth. Please read on.
Study data suggests that children younger than 3 years old receive roughly the same amount of protection from the flu vaccine regardless of whether the two recommended doses are administered by injection, nasal spray, or one of each, as reported in MSN.
The language is so important in cases such as this. Study data ‘suggests’. Now I can make a suggestion to you and you will take it as just that – a suggestion. But study data should not suggest – it should find or prove. Also, look at the source – there is no reference for this study through the entire (short) article. It keeps referring to MSN as being the source of this data but there is no primary reference nor, on searching the web, can I see where this ‘study’ has been published. There are just several other reports in the media which obviously came from the same press release. Journalism should be something more than just reporting what you have been told no matter the source.
NIAID director Anthony S. Fauci noted that “this study provides initial evidence that the prime and booster doses for these young children can be different types of flu vaccines and still provide adequate protection against matching seasonal flu strains.”
NIAID is the National Institute of Allergy and Infectious Diseases – a division of the National Institutes of Health in the US. A search of their website finds a link to the press release that all of these stories must have been taken from – you can read it by clicking here and the actual study report can be found by clicking here, though keep in mind that the results have never been published to the web, as far as I can see. I will get back to the study design in a little while, but for now, I want to discuss more of this lousy excuse for an article.
For the study, researchers examined 53 children ranging in age from 6 months to 35 months over the course of two years, during which children received the doses in one of the following manners: two injections of flu vaccine; two doses of the live, attenuated nasal spray; nasal spray followed by an injection; injection followed by the nasal spray.
You have GOT to be kidding me! There are tens of thousands of infants and children in that age range who get either the nasal flu or the injected flu vaccine every year in the US. Are they honestly trying to convince people that a study of 53 children is going to prove either safety or effectiveness? If this weren’t so sad, it would be laughable.
The investigators found that all four groups of children were safe and produced similar amounts of protective antibodies, but young children who receive at least one dose of the nasal spray vaccine had the broadest immune response, which could boost their protection against many diverse flu strains.
This is not surprising. The nasal spray is a live virus vaccine that delivers the dose over the mucous membranes in much the same way that we would contract the flu (or a cold or many other viral illnesses). It makes sense that antibody production would be highest in this group. Also, keep in mind that they said that all 4 groups of children (divide 53 by 4 and you find out that there could not have been more than 14 children in any one group – a statistically insignificant number to anyone who is actually trying to find out how safe or effective a treatment is as opposed to someone who is just trying to get a good headline to push their own agenda) were safe using these protocols. We will come back to that.
However, the study pointed out that the live, attenuated flu virus has been linked to wheezing in the youngest recipients, so the researchers concluded that the best regimen for children younger than 24 months might be one injected dose followed by one live, attenuated dose of the seasonal flu vaccine.
The medical definition of a rare side effect is one that happens in fewer than 1:10,000 doses of a treatment. We have a total study group of 53 children and in such a small group, they found an increase in wheezing and this is not a cause for alarm? But of course not! We can’t say that the wheezing caused by this live virus vaccine is associated with an increased risk of asthma because ALL vaccines are good and safe – just some are better and safer. Instead, we are told that we can still use both injected and nasal spray vaccines – we just use one a bit earlier and one a bit later.
The drug companies are happy; the government is happy; and the parents don’t know any better and would never blame their child’s breathing problem on the vaccine their child received. After all, if it weren’t safe, the government would not have allowed it to be released, right?
Now, for the actual study. Remember, this is 53 children in total who received one of several different combinations of vaccines. This was supposed to show that not only was the vaccine effective but it was safe as well. In order to prove safety, we should have one group that gets a treatment and another that gets a placebo which by definition is a totally inert substance (eg saline solution). For anyone who has been following this issue for any time at all, you will not be surprised to hear that there was no control group. All 4 groups of children involved got 2 different types of vaccine. There was also no blinding of the groups so parents and researchers were aware of who was getting what treatment. Despite this, and despite the increase in wheezing, the vaccines were all declared to be safe. Bravo! Now for the inclusion criteria. These are the children who were ‘allowed’ to participate in the study.
- Twelve to 35 months of age at enrollment.
- Minimum weight of 8 kg.
- In good health, as determined by parent/guardian verbal medical history and physical examination by clinical investigator.
- Parent/guardian available by telephone for safety data collection through 6 months post-dose 2.
- Ability of parent/guardian to understand and comply with the requirements of the protocol.
- Signed informed consent document and Health Insurance Portability and Accountability Act (HIPAA) authorization by the parent/guardian prior to performance of any study procedures.
One can only imagine what the parents would have been told prior to their agreeing to put their children into this study. You can bet they weren’t told that all flu vaccines were found by the Cochrane Collaboration to be absolutely useless in children aged under 2 years old. Nor would they have been informed that even after 2 years old, children who are vaccinated against flu are no less likely to be hospitalised with influenza or to have the disease for a shorter duration. In any case, these are the children who ARE allowed into the study. Those who are NOT allowed in are much more interesting. Please keep in mind when reading this list that vaccination is a one-size-fits-all treatment. The only true contraindication to vaccination in the real world is an anaphylactic (severe, life-threatening allergic response) reaction to a previous dose. yet here, in a study that is supposed to show us that the vaccines are safe for all, are the kids who were not allowed in. I wonder if they only got 53 children in the final study because with so many vaccinated kids, it was hard to find children healthy enough to meet the criteria?
- History of hypersensitivity to any component of LAIV or TIV, including egg or egg products.
- History of hypersensitivity to gentamicin.
- Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies.
- Known close contact with a severely immunocompromised person, such as someone currently in isolation secondary to a bone marrow transplantation (LAIV recipients should avoid close contact with severely immunocompromised individuals for at least 7 days after vaccination).
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies.
- History of Guillain-Barré syndrome.
- History of asthma or reactive airways disease.
- Acute febrile (>99.6 degrees Fahrenheit axillary) and/or respiratory illness, within the 72 hours prior to enrollment.
- Use of aspirin or aspirin containing products in the month prior to enrollment or anticipated use during the study.
- Administration of any intranasal medication within 2 weeks prior to enrollment or expected receipt during this study.
- Previous receipt of an influenza vaccine.
- Administration of any live virus vaccine within 4 weeks prior to enrollment or (other than study vaccine) planned receipt of another live virus vaccine before completion of the 2 weeks after the last vaccination in this study*
- Administration of any inactivated vaccine within 2 weeks prior to enrollment or planned receipt of another inactivated vaccine before 2 weeks after the last vaccination in this study*
- Participation in another investigational trial or administration of any investigational drug within 1 month prior to enrollment or during this study.
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
- Routine immunizations can be resumed after the memory aid period following dose 2.
So in the ‘study’ that is supposed to be looking at how safe this vaccine is for the general population, people who would normally get the vaccine in real life are excluded, selecting a group that is less likely to react, therefore making the shot appear safer. And even the reaction that did appear – wheezing – was downplayed despite the fact that wheezing might be a precursor to asthma and there is at least 1 child or adult who dies from asthma each day in Australia and many more times that number in the US.
Lastly, this study purports to have looked at the effectiveness of the vaccine and found that both the flu shot and the flu nasal mist were effective at preventing flu. Did they do this by exposing these children to influenza and seeing whether they got sick or not? Did they do this by following them for a long period of time to determine whether or not the vaccine kept them safe against influenza and for how long?
Of course not!
The only indicator of ‘effectiveness’ they have is the development of antibodies. This is despite the fact that antibodies do not indicate immunity – even immunologists would have to admit that. Antibodies are stimulated by one small part of the immune system. They indicate exposure – not immunity. You can have very high levels of antibodies in your bloodstream and still contract the disease you have been told you are serologically immune to. Alternatively, you can have low or no circulating antibodies, be exposed to and harbour live virus or bacteria in your body and have no symptoms of disease.
So, the safety aspects of this study are non-existent and fraudulent. And the effectiveness aspects are no better.
Yet this news-by-press release is reported as though it were true. It is reported without question. And gullible parents, health professionals and journalists read the headline and think they know the whole story.
This precautionary tale is repeated every day in every single medical journal. The studies are designed to make the vaccines look effective. They are constructed to convey the impression of safety. But no truly scientific conclusions can be drawn from these studies because they are simply invalid.