October 2012 – Just as health officials are cajoling the public to line up for seasonal flu shots, ‘An Analysis of the Influenza Vaccine Enterprise’ reveals the inaccuracies of their arguments. It states that their recommendations during the past decade to target ever more age groups and health conditions for flu shots, “often were based on professional judgment and not on scientifically sound data.”
Influenza virus was discovered in 1933. The analysis, by M T Osterholm PhD, MPH et al, “reviewed in detail more than 12,000 articles, documents, transcripts and notes dating back to 1936.” Osterholm states: “it represents one of the most exhaustive reviews of any vaccine ever undertaken.” Chapter 3, ‘Efficacy, Effectiveness, and Cost-effectiveness of the Currently Licensed Influenza Vaccines’, is largely based on the authors’ meta-analysis published January 2012 in the Lancet (see this in Appendix B of the Analysis). Due to even greater methodological rigour than that employed by similar meta-analyses authored by the Cochrane Collaboration, the study suggests current flu shots are even less useful than the Collaborations’ research implies.
Out of 5,707 human influenza vaccine efficacy and effectiveness studies published in English in the PubMed database between Jan 1, 1967 and Feb 15, 2011, the authors found only 31 satisfied their stringent criteria for “adequate study design and conduct.” The criterion to which the Cochrane meta-analyses don’t conform is the inclusion of only those studies which used the gold standard RT-PCR (real-time reverse-transcriptase polymerase chain reaction) tests and/or viral cultures to confirm influenza infection. Osterholm et al explain that, “the antibody response to infection after vaccination is muted*** and if the only end point being measured is a serologic [antibody] response, then a substantial number of postvaccination infections will not be detected.”
*** In their Lancet study, Osterholm et al explain this further: “For example, the use of serology to confirm influenza infection in participants who were vaccinated with an inactivated [killed virus] vaccine had been recognized as problematic since the 1940s and 1950s. Investigators noted that the increased antibody titres [ haemagglutinin antibody levels] after vaccination in individuals given an inactivated vaccine made it difficult to document a four-fold rise in hemagglutinin antibodies necessary to confirm an influenza infection.”
The authors define the terms ‘efficacy’ and ‘effectiveness’: ‘efficacy’ means the ability to perform as intended and is determined by vaccine trials; ‘effectiveness’ means performance as intended and is determined by studies examining real life outcomes of vaccination. They state: “the currently licensed influenza vaccines can provide moderate protection against virologically confirmed influenza, but such protection is greatly reduced or absent in some seasons.” BUT, APPARENTLY, THE “GREAT REDUCTION” OR “ABSENCE” OF PROTECTION AGAINST INFLUENZA IS NOT DUE TO THE FLU SHOT VIRUSES BEING DISSIMILAR TO THOSE CIRCULATING. The authors’ most astonishing revelation is that, “we were unable to identify a clear protective impact associated with a good antigenic match across influenza seasons. In addition, in a study supported by the CDC, the effectiveness of the monovalent A(H1N1)pdm09 [A type H1N1 2009 ‘pandemic’] vaccine was only 56% despite the close match between the vaccine strain and the circulating pandemic virus.”
Osterholm et al note that possible serious health impacts of influenza are most significant “in particular for persons 65 years of age and older, as approximately 90% of deaths from influenza occur in this group.” However, “evidence for protection in adults 65 years of age and older with TIV [trivalent injected influenza vaccine] is lacking.” and, “the impact that influenza vaccination in children has on influenza outcomes at the population level remains uncertain.” In fact, “It remains unclear whether or not herd immunity plays a significant role in influenza prevention and control.” Concerning other high risk groups the authors declare, “We are not aware of any studies that report significant reductions in severe morbidity or mortality related to influenza vaccination in children 2 years of age and younger, pregnant women, or individuals with chronic health conditions.”
For TIV, the authors did find “evidence of moderate protection (pooled estimate of 59%) for healthy adults 18 to 64 years of age” but, “inconsistent evidence of protection in children age 2 to 17 years”. The 59% “protection” was only efficacy, not effectiveness. And, of course, flu shots can only be efficacious against true influenza which, according to Canada’s FluWatch records, has averaged only 10.2% of all influenza-like illness (ILI) for the last eleven non-pandemic influenza seasons (see VRAN Flu-like Watch table at /about-vaccines/specific-vaccines/influenza-vaccine-flu-shot/). Note that influenza symptoms are indistinguishable from those of all the hundreds of other viruses which can produce ILI; true influenza can be identified only by lab tests.
But one exception to the dismal efficacy/effectiveness of influenza vaccines is noted: “For LAIV [weakened live virus influenza vaccine], results demonstrated evidence of high protection (pooled estimate of 83%) for young children 6 months to 7 years of age”. Again, the 83% “protection” was only efficacy, not effectiveness. (Read five paragraphs below about the risks of FLUMIST®, the LAIV used in Canada.)
Whereas Osterholm et al found many problems re efficacy and effectiveness, they are relatively mute on risks. They do discuss the possibility that people with a history of severe allergic reactions to eggs might suffer anaphylaxis to the egg protein in flu shots. They also mention that, “Additional work is needed to determine if A(H1N1)pdm09 influenza vaccine [the 2009 ‘pandemic’ vaccine] is causally linked to an increased risk of GBS [Guillaine-Barré Syndrome]”, since there was an increased GBS rate of about one extra case for every one million people receiving the ‘2009/10 ‘pandemic’ vaccine. Well good luck on that! Researchers still haven’t discovered why the rate of GBS increased about 9-fold after the 1976 H1N1 flu shot campaign in the US.
The authors also mention two “unique” adverse events: an increase in febrile seizures and increased narcolepsy. The former occurred in 2010 in Australia and New Zealand after children younger than 5 yrs were injected with a CSL brand flu shot. In USA, where this vaccine was available in limited quantities, surveillance found 43 such children. A 2 yr CIL investigation found “more gene fragments and lipids” in their influenza vaccine than in similar vaccines but suggests the cause of the increased seizures is “complex and multi-factorial.” The increased narcolepsy occurred in Finland in 2010 after 4-19 yr olds were vaccinated with an adjuvanted Pandemrix vaccine which was used only in Europe: 4-19 yr olds had a 12.7-fold increase; those 16 yrs and younger had a 17-fold increase. And, while all cases examined had a genetic predisposition for narcolepsy, “The mechanism by which the vaccine induced narcolepsy…remains unclear…” There seems to be a pattern here; obviously, if investigators cannot figure out why a vaccine produces an adverse outcome, research has never discovered all its possible effects within our bodies prior to its licensing and use.
As usual, these findings are largely based upon data from passive reporting systems such as the US Vaccine Adverse Event Reporting System (VAERS). Due to parental ignorance that it exists, foot-dragging on the part of healthcare providers, and lack of recognition or acknowledgement of vaccine adverse events, VAERS receives reports of only some of all such events that occur. And whereas increased rates of rare events resulting from even a few vaccine-related cases are relatively easy to notice, detection of vaccine-related increased rates of common health problems (especially those which develop slowly as many autoimmune diseases do) is much more difficult…but not impossible. Asthma is an example of one such common health condition for which there is evidence of a link to flu shots. A 2012 study from Mayo Clinic reports a three-fold increased rate of hospitalization of influenza-vaccinated children, 6 mos-18 yrs old, especially those with asthma. And a 2009 study of data from a 2003 Canadian health survey of over 134,000 people found asthmatic patients who received flu shots were 80% more likely than unvaccinated controls to experience asthma flare-ups requiring the use of inhalers or nebulizers.
And what about the mercury that’s still in some flu shots? According to toxicologist, Mike Wagnitz, flu shots contain “levels of mercury 250 times higher than what is legally classified as hazardous waste.” How do we know, for instance, that macular degeneration – a leading cause of loss of vision in seniors – is not due at least in part to the mercury they’ve received via flu shots repeated over many seasons? As far as we are aware, this has never been investigated.
The FLUMIST® monograph shows it’s not without risks. Recall that this live virus nasal spray vaccine is the only influenza vaccine about which Osterholm et al say there’s some evidence of high efficacy (but only for young children 6 months to 7 years of age). The evidence provided in Table 1 on pgs 6-7 of the monograph indicates dubious effectiveness. Adverse reactions of children 2-17 yrs old included: runny/stuffy noses (64%), coughs (40%), headaches (13%), fever (11%), and muscle aches (8%) – all the symptoms of influenza and influenza-like illness (ILI). Pg 5 of the monograph tells us, “FLUMIST should not be administered to individuals with severe asthma”. Pg 10 lists serious reactions reported post-marketing: anaphylaxis, Guillaine-Barré Syndrome, Bell’s Palsy (temporary or permanent paralysis of the facial nerve which may cause an inability to open an eye or close the mouth), facial swelling, nosebleed, hives and rash. And, as is usual for vaccines, there’s the statement (pg 20): “FLUMIST has not been evaluated for its carcinogenicity or mutagenic potential or its potential to impair fertility.”
After claiming that current influenza vaccines have an “excellent safety record” but, “influenza vaccine protection is markedly lower than for most routinely recommended vaccines and is suboptimal”, Osterholm et al state that, “development of novel-antigen game-changing [read: “very expensive”] influenza vaccines must be declared a national priority by the US government. With that declaration must come the commitment to provide the resources and project management processes required to make novel-antigen game-changing vaccines a reality….A substantial investment by the US government in research and development and regulatory science, with new private-sector incentives, will be imperative in accomplishing this objective [read: “more gouging of taxpayers”]….a new organizational and leadership structure for the influenza vaccine enterprise [ read: “empire”] must be established…. Achieving these goals and bringing novel vaccines to the global market will require a highly coordinated leadership effort, similar to the mission-critical prioritization and project management approach of the Manhattan Project [We couldn’t think of a more appropriate comparison!].”
Nevertheless, despite their bashing of current influenza vaccine efficacy/effectiveness, Osterholm et al support today’s public health dogma by saying, “we believe current influenza vaccines will continue to have a role in reducing influenza morbidity until more effective interventions are available.” In other words, they expect us taxpayers to continue funding “free” near-useless and risky annual flu shots (costing $6.5 million in Alberta alone). Meanwhile, we should dig deeper into our pockets to fund even more expensive influenza vaccines which they expect would be “game-changing” but could prove to be just as useless and risky as the originals!