FLUAD was approved for use in those 65 years and older in June, 2011. Because it’s supplied already loaded into single-use syringes, it doesn’t contain the mercury-based preservative, thimerosal. But it certainly contains other risky ingredients, the most concerning of which is MF59C.1. This is an adjuvant composed of squalene, polysorbate 80, and sorbitan trioleate in citrate buffer, an oil-in-water emulsion similar to the controversial adjuvant which was added to the GlaxoSmithKline ‘pandemic’ influenza vaccine used in 2009 and 2010.
Apart from the three inactivated influenza viruses and the MF59C.1, FLUAD contains a long list of other ingredients and traces of materials used in the manufacturing process, some of which could be problematic: sodium and potassium chloride, potassium dihydrogen phosphate, disodium phosphate dehydrate, magnesium chloride hexahydrate, calcium chloride dehydrate, neomycin, kanamycin, residual egg protein, formaldehyde, cetyltrimethylammonium bromide and barium. The May 31, 2011 FLUAD ‘Prescribing Information’ monograph by Novartis Pharmaceutical Canada Inc. states that it is contraindicated for people who are hypersensitive to any of these. The monograph warns, “FLUAD has not been evaluated for…carcinogenic or mutagenic potential.”
It states that, “FLUAD may be given at the same time as other vaccines.” but, if this is done, “It should be noted that any adverse reactions may be intensified.” It also admits that no studies have been done to evaluate possible harmful drug interactions with FLUAD.
Concerning its administration, the monograph stipulates that FLUAD should be allowed to reach room temperature and protected from light before it’s injected; it should not be injected into any muscle tissue such as the buttock, where there is a major nerve trunk and “should under no circumstances be administered by any other route than intramuscularly.”
Concerning efficacy, the monograph admits: “Specific levels of hemagglutination inhibition (HI) antibody titers induced by vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness.” In other words, the measure that’s assumed would provide evidence for influenza prevention – a specific degree of post-injection antibody production – has never been discovered. Nevertheless, five “pivotal” clinical trials with a total of 1168 FLUAD-injected participants were considered rigorous enough to support the immunogenicity of FLUAD. Their results all showed greater antibody production than that produced by two other influenza vaccines. But Novartis has had to conclude that, “clinical relevance of the difference is unknown.”
It’s not surprising that FLUAD’s powerful adjuvant boosts its antibody response to a level greater than that obtained from influenza vaccines without such an adjuvant. The monograph notes FLUAD’s antibody response is most pronounced against influenza B and A/H3N2 viruses and adds, “This increased response is seen particularly in elderly subjects with low pre-immunization titre [antibodies already present prior to vaccination] and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza infection.” However, one suspects that a person who’s more likely to be injured from influenza infection, is also more likely to be injured by a powerfully adjuvanted influenza vaccine.
The monograph tells us that FLUAD was first licensed in Italy in 1997 and is now registered for marketing in many countries worldwide. But, up until the 1950s when US army scientists injected troops with oil adjuvants, they had been viewed as much too dangerous to be used on humans; it was known at that time that oil adjuvants cause autoimmune disease. In the 1970s, UCLA experiments searching for ways to make vaccines more effective found squalene to be one of two of the many oils tested to be the most likely to produce arthritis in lab rats. Perhaps the reason FLUAD continues to be marketed is that many seniors already have autoimmune disease when they’re vaccinated so it’s thought there’s no need to withhold the vaccine on account of risk of acquiring it. On the other hand, for those in whom autoimmune disease is lacking, perhaps it’s conjectured that such disease would take so long to develop that the vaccinated senior wouldn’t live long enough for it to manifest!
The risk data in the FLUAD monograph come from 39 small safety trials with a total of 12,889 FLUAD-injected participants as well as post marketing experience. Numerous post marketing adverse events involving the immune system, blood, skin and nervous system have been reported. The monograph shows pooled data from three groups of safety trials: in 31 trials participants received only one annual FLUAD injection; in 5 trials they received two consecutive annual injections; and in 2 trials they received three consecutive annual injections. Overall, 37% of partipants experienced one or more of several possible reactions at the injection site after one injection. The most frequent of these were pain and heat. Systemic effects such as myalgia, fatigue, headache and malaise were experienced by 17%. Amongst the 487 participants who received two annual injections, there were sizeable increases in injection site reactions in the second year. Amongst the 149 injected three times, each successive vaccination resulted in increased heat and inflammation; although pain varied little, it was experienced by 28% even after the first vaccination.
It should be noted that the safety trial data “were collected from subjects who completed a symptom diary card for at least four days following vaccination.” This could mean that some subjects (participants) didn’t fill out cards at all or filled them out, but for less than four days. Considering this, the possibility of memory impairment in this age group, the limited number of participants and the short adverse event reporting period required, how likely is it that this data has any relevance to risk posed to seniors vaccinated Canada-wide? And we know adverse events reporting is a ‘hit and miss’ affair with the emphasis on the ‘miss’; post marketing reports completed to date cannot be expected to reveal the true level of risk that FLUAD vaccinations pose. Considering the poor efficacy of influenza vaccines in general, especially in seniors, and the unknown immunogenicity of FLUAD; considering the high risk adjuvant and other ingredient risk; and considering the inconclusive data of vaccine trials – is use of this vaccine warranted?
‘Prescribing Information’; FLUAD; Novartis Pharmaceutical Canada Inc.; May 31, 2011; (click on ‘Prescribing Information’)
Vaccine A by Gary Matsumoto; Chapter 3
Swine flu vaccine – a public health experiment; VRAN ‘In the News’ (a thorough, fully referenced discussion of the 2009/2010 ‘pandemic’ vaccine which includes information about squalene, M59 adjuvant and FLUAD)