Click for list of papers in this post.

The recommendation for the influenza vaccine does not meet accepted standards of evidence-based medicine. Specifically, influenza vaccine studies are typically observational, not randomized or placebo controlled. The vaccine advocates say randomized trials are unethical because the control group subjects would be denied the benefit of the vaccine.

The problem with this argument is that it presumes the influenza vaccine is beneficial. But proof of benefit requires randomized, placebo-controlled, double-blind studies. Observational studies cannot prove that the vaccines causes benefit. Observational studies can only show correlation; they cannot prove causation. And correlation is not causation.

Observational studies of the influenza vaccine (and vaccines generally) have severe problems with selection bias. The people that choose to get the influenza vaccine have more “health seeking” behavior than people that don’t get it, and this almost certainly explains why the influenza vaccine is associated with good health outcomes. The problem of selection bias in vaccine studies is explained here: Healthy User Bias: Why Most Vaccine Safety Studies Are Wrong

However, there are a few randomized, placebo controlled studies of influenza vaccines, and they have worrisome results.

A Randomized Study in Children

A 2011 study found that the influenza vaccine increased non-influenza illnesses in children. In this study 115 children (age 6-15 years) were randomized to receive vaccine or placebo. Vaccines and placebos were administered in Nov and Dec, and the subjects were followed for 9 months. They were monitored for illnesses and viral infection. Laboratory analysis determined the type of virus present, in case of illness.

Full paper (Cowling, 2012): Increased risk of noninfluenza respiratory virus infections associated with receipt of inactivated influenza vaccine

The results were not good for the vaccine. The rate of influenza infection was almost exactly the same on both groups (4.3% vax vs 6.5% unvax, different insignificant). The vaccinated group had a 4.4-fold higher risk of experiencing a non-influenza infection. 29% (20) of those receiving the vaccine got a non-influenza infection, compared to 6.5% (3) of the unvaccinated. This result was statistically significant, with P<0.01.



Above: Trivalent inactivated vaccine (TIV) did not reduce influenza, and it caused non-influenza infection. Children that received the influenza vaccine were 4.4x more likely to suffer a non-influenza infection. From Cowling et al. 2012.

The most common non-influenza infections were rhinovirus and coxsackie virus. These viral illnesses are typically mild, but can cause serious harm in susceptible people. Also, other respiratory viruses were reported.

The authors state:

“We identified a statistically significant increased risk of noninfluenza respiratory virus infection among TIV recipients (Table 3), including significant increases in the risk of rhinovirus and coxsackie/echovirus infection….”

AND

“Vaccine recipients may lack temporary non-specific immunity that protected against other respiratory viruses.”

TIV=trivalent influenza vaccine

Of course, this raises the concern that the vaccine may increase susceptibility to infections more dangerous than influenza, rhinovirus or coxsackie. This will be case if the immune impairment is truly non-specific (as hypothesized by the researchers). It is not known how broad or long-lasting the immune impairment is.

The non-influenza infections occurred mostly in January and March, 1 and 3 months after vaccination. This of course implies that the immune suppression from the vaccine lasts for at least 3 months. See Figure 1 in the Cowling paper.

Influenza Vaccine in Young Children

An increased rate of non-influenza illness was also observed in a study of the influenza vaccine, by a researchers in Australia. Subjects (381 total) were children, aged 6-35 months. This was not a randomized placebo-controlled study like the Cowling study above; the subjects (i.e. their parents) chose whether to administer the influenza vaccine or not. Hence, the study was susceptible to selection bias (i.e. vaccinated and unvaccinated groups will be different in health-seeking behavior). Even so, the results are interesting, and suggest the vaccine causes harm.

Subjects were assigned to three groups, depending on which vaccines they chose to receive:

Fully vaccinated (n=91): Typically received two doses

Partially vaccinated (n=52): Typically received one dose

Unvaccinated (n=238): Received no influenza vaccine

Subjects were tracked for 13 weeks. Fully and partially vaccinated subjects had increased risk for non-influenza infection. There was no difference in influenza. These results are consistent with the Cowling 2012 study above.

Full Study (Dierig et al, 2014): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181477/pdf/irv0008-0293.pdf

Key results are shown below.

Above: Full vaccination for influenza (2 doses) was associated with a 1.6x risk of non-influenza infection, and a 1.23x risk of virus detection (in sinus or throat) compared to controls (both resuls statistically significant). There was no difference in influenza infections. Subjects were age 6-35 months and followed for 13 weeks. The unvaccinated group had fewer past hospitalizations. The unvaccinated children were healthier both before and during the study. From Dierig et al, 2014.

Dierig et al describe the results:

“We did, however, unexpectedly find that non-influenza ILI (influenza-like illness) occurred about 1.6 times more commonly in children vaccinated with one or two doses of the influenza vaccine than in unvaccinated children. These results support the findings of a recent RCT (randomized controlled trial) reported by Cowling et al.”

AND

“The non- influenza virus incident rate ratio (IRR) was higher in the Hong Kong study (4.4 versus 1.6), but there are some key differences to our study, including age of subjects, follow-up period, proportion of illnesses swabbed and proportion of swabs yielding viruses. As with all observational studies, bias must be considered.”

“Cowling et al” and “Hong Kong study” refers to Cowling 2012, cited above

Interestingly, unvaccinated children had significantly (P=0.01) lower hospitalization rate than fully or partially vaccinated children, even before the study started. This may be because the unvaccinated children received fewer vaccines in general (based on an assumption that those refusing the flu vaccine also refuse other vaccines). Hence, the observed differences in hospitalization may be explained by vaccine injury from first-year vaccines.

Dierig suggest the hospitalization rate difference may be because “families that vaccinate children have a prior preference for greater healthcare service usage.” But is it preference or need? This speculation by Dierig is contradicted by a statement in the paper:

“We could find no evidence of different parental responses to ILIs (influenza-like illness) in vaccinated and unvaccinated children: parents of vaccinated children were no more likely to seek medical care during an ILI.” ILI= influenza-like illness

In other words, the groups had the same tendency to seek medical care, and therefore dose not explain the differences in hospitalization. Hence, the most reasonable explanation (for the higher illness rate among the vaccinated) is that the influenza vaccine caused non-influenza illnesses. And of course, this is consistent with the Cowling study, which was higher-quality since it was a placebo-controlled randomized trial. The Cowling study proves causation, because it was randomized.

The Dierig study is an excellent example of the ambiguities and selection bias inherent to observational (i.e. non-experimental) trials. Since there was no randomization, the groups are not matched and therefore one can interpret the results in numerous ways, depending on personal biases, opinions and beliefs. This is why observational studies are not good enough to establish vaccine safety.

Randomized, Placebo-Controlled Trial in Adults

An increased illness rate was also observed in a randomized study of adults working at a Ford factory. This study was conducted by the Centers for Disease Control (CDC). This is a great study because it lasted for 2 influenza seasons and it had over 1100 subjects both years. In the first year, the vaccine was not well matched to circulating strains (50% efficacy, which is typical); in the second year, circulating influenza was very well matched (86% efficacy, which is exceptionally high and very unusual).

This study was large, with 1130 and 1178 participants in years 1 and 2. Half received the vaccine, and half received a saline placebo. Unfortunately, this study was not well-blinded because a vaccine produces irritation at the injection site that does not occur in those receiving saline placebo. So, many study subjects knew if they received the vaccine or not. So the blind was ineffective.

The study found that in year 1 (97-98), when the vaccine had low (but typical) effectiveness, the vaccine increased illness, lost workdays, lost hours and days ill. In year 2 (98-99), when the vaccine was well matched, the vaccine reduced illnesses, lost workdays and physician visits.

Full Paper (Bridges et al): Effectiveness and Cost-Benefit of Influenza Vaccination of Healthy Working Adults: A Randomized Controlled trial



Above: Results of randomized placebo-controlled trial of influenza vaccine, in two flu seasons. In year 1, the vaccine had poor efficacy and caused illnesses. In year 2, the vaccine was exceptionally well matched and reduced illnesses. Vaccine effectiveness for influenza was 50% and 86% for years 1 and 2, respectively. The vaccine increased susceptibility to influenza when it is not well-matched to circulating influenza strains. This is consistent with animal experiments and the “original antigenic sin” effect. Statistically significant (or almost significant) results are marked in red. From Bridges et al, 2000.

So the influenza vaccine increases illnesses when its poorly matched, and reduces illnesses when its well matched. This suggests that the flu vaccine provides no net benefit on average. Flu vaccine efficacy is not predictable, and efficacy data is generally not available until flu season is well underway or over. So at the time when the vaccine is given, one does not know if it will cause or prevent illness.

The CDC is biased to promote vaccines and dishonestly downplay adverse effects. Consistent with this, the paper ignores the adverse effects caused by the vaccine in year 1. For example, the Bridges paper dishonestly characterizes the results like this:

“[In year 1] vaccination did not reduce ILI (influenza-like illness), physician visits, or lost workdays.”

AND

“No other adverse effects, including fever, myalgia, headache, fatigue, rhinitis, or sore throat, were reported significantly more often by vaccine recipients, nor did they report significantly more lost workdays or physician visits.“

These statements are blatantly misleading and false. In year 1, the vaccine caused increases in lost workdays, hours lost to physician visits, and number of days ill. Incredibly, the paper does not mention these harmful effects.

In year 1 the vaccine increased illness severity. This is expected in view of the Cowling results above and the evidence of immune suppression by the influenza vaccine (more on this below).

The Bridges study only discusses things that make vaccines look good.

Original Antigenic Sin

A poorly-matched influenza vaccine may cause illness (and increase risk of influenza illness) by a phenomenon in immunology known as “original antigenic sin” (OAS). First discovered in 1960, OAS is well known and firmly established. Its described in any immunology textbook. OAS occurs in this scenario:

1) There is an illness with pathogen strain #1. The immune system learns and remembers how to make antibodies for strain #1. Pathogen can be virus, bacteria etc.

2) There is a second illness with strain #2, of the same pathogen. For example dengue virus is well known to cause OAS (dengue has 4 strains).

3) During the second illness, the immune system responds as if strain #1 is attacking, because it “remembers” strain #1. The problem is that the antibodies for strain #1 are not effective against strain #2 (the antibodies are not a good fit). The result is a defective (and delayed) immune response. The illness from strain #2 is therefore much worse. In fact, it can be life threatening (this happens with dengue).

OAS is why a first dengue illness is mild, but a second case of dengue (involving a different dengue strain) can be very severe and long lasting. A second dengue infection can be fatal due to OAS.

By receiving an influenza vaccine that is poorly matched to circulating strains, the immune system is improperly trained. Improper immune training is worse than no training at all. The OAS phenomenon may explain the results of the Bridges study.

The human papilloma virus (HPV) vaccine might cause OAS because not all strains of HPV are included in the vaccine. There are about 200 strains of HPV, and only 9 are included in the most recent version of Gardasil. A vaccinated person may be more vulnerable to the 190 or so strains not included in the vaccine.

You can read more about OAS here: https://en.wikipedia.org/wiki/Original_antigenic_sin

There have been many anecdotal reports of people becoming sick from the influenza vaccine. These anecdotes are supported by the Cowling, Dierig and Bridges studies. And OAS may increase the danger of influenza in years when the vaccine is not well matched to circulating influenza strains.

More Science Showing Immune Impairment By Influenza Vaccine

There are several other studies showing that the influenza vaccine causes immune impairment.

CD+ T-cells are specific types of immune cells targeting specific types of pathogens. CD8+ T cells are necessary for proper immune function.

In the following study by Bodowes, it was found that annual influenza vaccination was associated with a reduction in the number of CD8+ T-cells. This will reduce immunity. Main results are shown below.



Above: Children receiving annual influenza vaccines had significantly (P<0.05) reduced number of CD8+ T cells, an important type of immune cell responsible for heterosubtypic immunity (HI).

Specifically, lower numbers of CD8+T cells will reduce “heterosubtypic immunity” (HI). “Heterosubtypic immunity” refers to immunity to pathogens different from pathogens the immune system has already been exposed to. In other words, HI is when an exposure to one type of pathogen creates immunity to different but similar pathogens. HI is essentially the opposite of original antigenic sin. HI is important for providing broad-spectrum immunity against viruses like influenza that change constantly. Bodowes states:

“…long-term annual vaccination using inactivated vaccines may hamper the induction of cross-reactive CD8+T cell responses by natural infections and thus may affect the induction of heterosubtypic immunity. This may render young children who have not previously been infected with an influenza virus more susceptible to infection with a pandemic influenza virus of a novel subtype.” (emphasis added)

HI is provided by natural infections, but not the influenza vaccine. Influenza vaccines reduce HI, apparently by reducing the number of CD8+ T cells.

The influenza vaccine reduces HI in those who receive the vaccine annually, and therefore can be expected to cause increased illness by strains different from the strains in the vaccine.

Full paper: Annual Vaccination against Influenza Virus Hampers Development of Virus-Specific CD8 T Cell Immunity in Children

Further, Bodowes published 2 papers on this effect in controlled experiments in ferrets and mice. He found that natural infection enhanced HI, but influenza vaccination impaired HI. Influenza vaccination dramatically increased the severity of a later acquired influenza infection. In the study on mice, Bodowes states:

“Here we show in a mouse model that the induction of protective heterosubtypic immunity by infection with a human A/ H3N2 influenza virus is prevented by effective vaccination against the A/H3N2 strain. Consequently, vaccinated mice were no longer protected against a lethal infection with an avian A/H5N1 influenza virus. As a result H3N2-vaccinated mice continued to lose body weight after A/H5N1 infection, had 100-fold higher lung virus titers on day 7 post infection and more severe histopathological changes than mice that were not protected by vaccination against A/H3N2 influenza.” (emphasis added)

AND

“Prior infection with seasonal influenza viruses, which generally results in a self-limiting upper respiratory tract infection, may afford at least partial protection against potentially pandemic heterosubtypic influenza virus strains.”

AND

“…it [vaccination] may interfere with the induction of heterosubtypic immunity against potentially pandemic strains of a novel subtype, e.g. H5N1, by creating an immunological ‘‘blind spot.’’

And in the study on ferrets, Bodowes states:

“The vaccinated ferrets suffered more from the subsequent infection with the highly pathogenic H5N1 influenza virus A/Ind/5/05 than did their unvaccinated counterparts. These findings in the ferret model are in concordance with those we obtained recently with the mouse model.”

Full paper: Vaccination against Human Influenza A:H3N2 Virus Prevents the Induction of Heterosubtypic Immunity against Lethal Infection with Avian Influenza A:H5N1 Virus

Ferrets are good models for influenza in humans. Ferrets respond to influenza infection and influenza vaccines very similarly to humans.

Conclusion

Immune suppression from the influenza vaccine has been observed in human studies, and is supported by findings of reduced CD8+ T cells in vaccinated humans. And these effects have been confirmed in multiple animal studies, using two different types of animals.

It is clear that immune suppression from the influenza vaccine is a real effect.

For many years natural medicine advocates have warned that vaccines impair immune function and that natural infections provide immune benefits that are not provided by vaccines. The above scientific results prove natural medicine advocates correct.

In view of the above results, the influenza vaccine likely causes more problems than it prevents. The benefits provided by a wall-matched vaccine are likely cancelled by the harm caused by a poorly matched vaccine. And of course this does not include the risk of severe neurological damage (e.g. Guillan-Barre syndrome, demyelinating disease), or the risk of autoimmune disease.

A more effective, safer and scientifically-supported approach to protecting yourself from infectious diseases and influenza is to use zinc and vitamins A, D, and C. Other nutrients are also helpful.

For further reading, see these two papers by Dr Peter Doshi of Johns Hopkins U.:

Influenza Vaccines Time for a Rethink, JAMA, 2013

Influenza: Marketing vaccine by Marketing Disease, British Medical Journal, 2013

Papers in this post: