Last year was a nightmare year for pro-vaxers because the flu vaccine simply did not work.
The aftermath was a very high death toll (around 1000 people-90 percent involving the elderly).
This year the Federal Government is providing two new “enhanced” flu vaccines for free to people over 65 that involve a “fix” designed to circumvent the issues associated with the structure of the failed vaccine.
The Chief Medical Officer, Professor Brendan Murphy, believes the new “enhanced” vaccines will be more effective.
“We are pretty confident this will be better protection,” he said.
“No flu vaccine is complete protection, the standard vaccine seems to protect well in younger people, but we are confident this will give better protection for the elderly.”
So official “confidence” rather than good “evidence” to support efficacy and safety is the current standard utilised, meaning that there is a high level of risk still inherent in the use of the recommended vaccines.
Federal health minister, Greg Hunt, also echoes the same sentiments.
But the history of flu vaccines does not support this optimism because of one major flaw.
The viruses used are basically those that circulated in the northern hemisphere during their last flu season and all viruses can, and do, rapidly mutate to a different version of the original virus thus rendering any vaccine prepared in advance of Australia’s flu season totally ineffective.
Even more so if the vaccine is prepared using an egg-based medium-now proven to accelerate mutation.
As from April 1 two vaccines, (Fluad and Fluzone High Dose), will be available through the National Immunisation Program following a recommendation from the Pharmaceutical Benefits Advisory Committee.
The new trivalent vaccine works in over 65’s by generating a strong immune response and are more effective for this age group in protecting against influenza.
Fluad contains an adjuvant, which triggers the stronger immune response, and Fluzone contains four times the active ingredient, which also triggers a stronger immune response.
An expert committee reviewed and evaluated data related to epidemiology, characteristics of recent influenza isolates circulating in Australia and the Southern Hemisphere, serological responses to 2016-2017 vaccines, and the availability of candidate vaccines, viruses and reagents.
The TGA says it has accepted all of the Committee’s recommendations, one of which is that the TGA adopt the WHO recommendation issued for the 2018 Southern Hemisphere influenza vaccines.
According to this recommendation, the trivalent influenza vaccine components for the Australian 2018 influenza season should contain the following:
A (H1N1): an A/Michigan/45/2015 (H1N1)pdm09 like virus
A (H3N2): an A/Singapore/INFIMH-16-0019/2016 (H3N2) like virus
B: a B/Phuket/3073/2013 like virus.
The quadrivalent influenza vaccine for the Australian 2018 influenza season will contain the trivalent influenza vaccine components listed above, and the additional B strain:
B: a B/Brisbane/60/2008 like virus.
The Committee’s recommendation for the composition of influenza vaccines for Australia in 2018 introduces a new A (H3N2) like virus strain when compared to the composition of the trivalent and quadrivalent vaccines for Australia in 2017.
But the devil is in the detail.
The adjuvant in Fluad has the innocuous title of MF59.
MF59 is an immunologic adjuvant that uses squalene.
It is Novartis‘ proprietary adjuvant that is added to influenza vaccines to help stimulate the human body’s immune response through production of CD4 memory cells.
MF59 is the first oil-in-water influenza vaccine adjuvant to be commercialised in combination with a seasonal influenza virus vaccine.
MF59 is used as an adjuvant in Europe and in the United States.
It was developed in the 1990s by researchers at Chiron Corporation, a Novartis heritage company, acquired by Novartis in 2006
Flu vaccines can also contain a number of chemical toxins, including ethylene glycol (antifreeze), formaldehyde, phenol (carbolic acid) and even antibiotics like Neomycin and streptomycin.
Thiomersal is also present in multi-dose vials.
In addition to the viruses and other additives, many vaccines also contain immune adjuvants like aluminum and squalene.
The purpose of an immune adjuvant added to a vaccine is to enhance and exaggerate an immune response to the vaccination.
Adjuvants cause your immune system to overreact to the introduction of the organism you’re being vaccinated against.
Adjuvants are supposed to get the job done faster (but certainly not more safely), which reduces the amount of vaccine required per dose, and the number of doses given per individual.
Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time.
A 2000 study published in the American Journal of Pathology demonstrated a single injection of the adjuvant squalene into rats triggered “chronic, immune-mediated joint-specific inflammation,” also known as rheumatoid arthritis.
The researchers concluded the study raised questions about the role of adjuvants in chronic inflammatory diseases..
In humans, the immune system recognizes squalene as an oil molecule native to your body.
It is found throughout your nervous system and brain.
In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties.
The difference between “good” and “bad” squalene is the route by which it enters your body.
Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant.
Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system.
Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene.
MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets.
And this is what is contained in the proposed Australian Fluad flu vaccine!
The US Department of Defence made every attempt to deny that squalene was indeed an added contaminant in the anthrax vaccine administered to Persian Gulf war military personnel – deployed and non-deployed – as well as participants in the more recent Anthrax Vaccine Immunization Program (AVIP).
However, the FDA discovered the presence of squalene in certain lots of AVIP product.
A test was developed to detect anti-squalene antibodies in GWS patients, and a clear link was established between the contaminated product and all the GWS sufferers who had been injected with the vaccine containing squalene.
A study conducted at Tulane Medical School and published in the February 2000 issue of Experimental Molecular Pathology included these stunning statistics:
“ … the substantial majority (95%) of overtly ill deployed GWS patients had antibodies to squalene.
All (100%) GWS patients immunized for service in Desert Shield/Desert Storm who did not deploy, but had the same signs and symptoms as those who did deploy, had antibodies to squalene.
In contrast, none (0%) of the deployed Persian Gulf veterans not showing signs and symptoms of GWS have antibodies to squalene.
Neither patients with idiopathic autoimmune disease nor healthy controls had detectable serum antibodies to squalene.
The majority of symptomatic GWS patients had serum antibodies to squalene.”
According to Dr. Viera Scheibner, Ph.D., a former principal research scientist for the government of Australia:
“… this adjuvant [squalene] contributed to the cascade of reactions called “Gulf War Syndrome,” documented in the soldiers involved in the Gulf War.
The symptoms they developed included arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS (amyotrophic lateral sclerosis), Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhoea, night sweats and low-grade fevers.”
While public health officials insist vaccination is the best way to prevent the seasonal flu, the evidence calls this assumption into question, and most health care professionals won’t even get the flu shot if it’s voluntary.
This has led to recent calls from Australian health officials to make flu vaccine mandatory for health workers in hospitals working in specific wards, (where there may be immunocompromised patients), or in nursing homes where the patient population is elderly, with weaker immune systems.
The threat for a refusal to vaccinate is dismissal or a set of discriminatory workplace rules has to be observed if an exemption is sought..
Coincidentally, there is a similar recent call in the UK but more moderate voices are currently prevailing and state that compliance would be more readily achieved through ease of availability of flu vaccines, and a focus on education of the health workers involved.
In its 2014 meta-analysis of the available research on inactivated influenza vaccines, the Cochrane Collaboration (which is considered by many as the gold-standard for scientific meta-reviews), reviewed evidence related to influenza and influenza-like illness (ILI) that people experience during flu seasons and stated:
Over 200 viruses cause ILI, which produces the same symptoms (fever, headache, aches, pains, cough and runny nose) as influenza. Without laboratory tests, doctors cannot distinguish between ILI and influenza because both last for days and rarely cause serious illness or death. The types of virus contained in influenza vaccines are usually those that are expected to circulate in the following influenza seasons, according to recommendations of the World Health Organization (seasonal vaccine).
The Cochrane researchers concluded that:
Injected influenza vaccines probably have a small protective effect against influenza and ILI (moderate-certainty evidence), as 71 people would need to be vaccinated to avoid one influenza case, and 29 would need to be vaccinated to avoid one case of ILI. Vaccination may have little or no appreciable effect on hospitalizations (low-certainty evidence) or number of working days lost.
While health officials are fond of saying that getting a flu shot will lessen your symptoms should you contract influenza, French researchers disagree, noting that “very few studies have addressed the question of whether the vaccine mitigates influenza severity among those who develop the illness despite being vaccinated.”
Vaccine researchers in France decided to test the hypothesis by looking at data from vaccinated and unvaccinated elderly patients diagnosed with influenza.
The results were published in April 2017.
What they found was a rather insignificant lessening of symptoms, limited to a reduction in initial headache complaints among those who had been vaccinated:
Compared to non-vaccinated influenza patients, those who had been vaccinated had a slightly reduced maximum temperature and presented less frequently with myalgia, shivering and headache. In stratified analyses, the observed effect was limited to patients infected with A(H3) or type B viruses. After adjusting by age group, virus (sub)type and season, the difference remained statistically significant only for headache, which was less frequent among vaccinated individuals.
Poor influenza vaccine effectiveness is often blamed on viral mutations occurring while the selected influenza viruses are grown in the lab but, according to a team of researchers from the University of Chicago and Harvard University, poor immune responses in individuals appear to be a more likely reason.
In their study, the flu vaccine failed to elicit a strong immune response in most participants.
As explained in the press release:
“What’s at play seems to be a phenomenon known as ‘original antigenic sin.’ Flu vaccines are designed to get the immune system to produce antibodies that recognize the specific strains of the virus someone may encounter in a given year. These antibodies target unique sites on the virus, and latch onto them to disable it.”
“Once the immune system already has antibodies to target a given site on the virus, it preferentially reactivates the same immune cells the next time it encounters the virus. This is efficient for the immune system, but the problem is that the virus changes ever so slightly from year to year. The site the antibodies recognize could still be there, but it may no longer be the crucial one to neutralize the virus.”
“Antibodies produced from our first encounters with the flu, either from vaccines or infection, tend to take precedence over ones generated by later inoculations. So even when the vaccine is a good match for a given year, if someone has a history with the flu, the immune response to a new vaccine could be less protective.”
The dilemma that most Australian community pharmacists (indeed, all pharmacists) now face is how to deal with issues of informed consent while health leaders (including pharmacy leadership groups) parrot a “party line” that is not based on scientific evidence.
If the vision of expanding a segment of the vaccination market to its fullest extent is to be converted to a new revenue stream, then there has to be a rapid upgrade in the safety and efficacy of all vaccines.
And given that community pharmacy’s direction lies in delivering health literacy consultations, how can the general public continue to trust pharmacists to the level they currently do?.
Ethics and honesty must prevail if the pharmacy profession is to survive.