October 2011 – The World Health Organization has recommended that, in the Northern Hemisphere, the 2011-12 influenza vaccine contain the same three viral strains as those used in 2010-11. If their prediction of circulating strains is reliable, many Canadians, through previous exposure to the infection or the vaccine, will already be immune. If the prediction is faulty, the new vaccine will have little or no efficacy.
The National Advisory Committee on Immunization (NACI) contends that, “Even when the vaccine strains have not changed, as in 2011-2012, annual immunization reinforces optimal protection.” However, knowing the dismal efficacy of the flu shot and the fact that influenza comprises only about 10% of all flu-like illness experienced by Canadians, one wonders how “optimal” the reinforcement would be.
An interesting question to ask is why has there been little change in the circulating viruses since last influenza season? Viral populations generally survive either by a great ability to multiply in their hosts or by having many easily-infected hosts available. Could it be that, despite continually expanding vaccine programs, the immunity of Canadians has been waning? If so, have these programs actually helped degrade overall good health and associated strong immunity?
Eight influenza vaccines are licensed for use in Canada. Six will be taxpayer-funded for “free” vaccinations: GlaxoSmithKline’s Fluviral®, Sanofi’s Vaxigrip® and Intanza®, Novartis’ Agriflu® and Fluad® and AstraZeneca’s Flumist®. The latter is the only one containing live viruses and sprayed into the nostrils rather than injected. Fluviral® contains the mercury compound thimerosal as do the multi-dose vials of Vaxigrip®. Fluad®, which is the only one restricted for use in those 65 yrs and older, contains a powerful squalene-containing adjuvant, MF59. It’s similar to the controversial adjuvant which was used in the 2009-10 ‘pandemic’ H1N1 vaccine, but that vaccine contained only one viral strain. Intanza® is the only one of the six restricted to those 18 yrs and older and the only one injected into the skin rather than into muscle tissue. It is recommended for immune compromised adults and injected in lower-than-usual doses with higher-than-usual concentrations of immune stimulating antigen. All the Canadian licensed influenza vaccines contain egg protein, most contain formaldehyde and antibiotics and all contain other undesirables. (*See last paragraph re US vaccine, Fluzone High-Dose®.)
A new recommendation for 2011-12 is injection of influenza vaccines into egg-allergic Canadians despite the risk of severe reactions and even death. (This recommendation does not include the live virus nasal vaccine which is acknowledged to be risky for any immune-compromised people, egg-allergic or not.) The protocol for injection will be a full dose for those “at lower risk for severe allergic reaction” followed by 30 minutes observation; “higher risk” people will first be injected with 10% of a full dose, observed for 30 minutes and, if there’s no lasting reaction, injected with the remaining 90% and observed for 30 minutes, 60 minutes or more. Meanwhile, “Appropriate resuscitative equipment should be immediately available”.
Carrying their recommendation to the extreme, the NACI continues, “Children who are to get a second influenza vaccination [note that they don’t say ‘immunization’] during the same season can, if the first dose is tolerated well, be given a single dose of the same product used for the initial administration, which need not be from the same vaccine lot. A graded process is not needed for this second dose.”
And those childhood doses?….the new recommendation for the egg-allergic is coupled with a recommended increase from half to full doses of influenza vaccine for children 6-35 months old “whether the child is being given one dose of TIV [trivalent inactivated vaccine] or a two dose series.” The NACI’s excuse for this is that, “it will simplify the administration schedule” and, “Infants and toddlers have a high burden of illness and their response to TIV is not as robust as older children….NACI has reviewed published and unpublished evidence for use of full dose in infants that suggests moderate improvement in antibody response without increase in reactogenicity with use of full doses.”
These new recommendations raise several questions. Why does it apparently not matter that, as well as being inherently risky, the new protocol for egg-allergic people will be complex, inefficient and quite possibly unpredictable and confusing enough to result in administration errors? Why is it so important to “simplify administration schedules” and possibly gain “moderate improvement in antibody response” [which doesn’t necessarily indicate improved efficacy] by doubling doses for those in the vulnerable early stages of life? And, finally, WHY do “infants and toddlers have a high burden of illness”? The NACI informs us that, according to IMPACT data on 533 patients at Canadian children’s hospitals, “Among the 151 paediatric cases between 6-23 months of age, 41 (27.1%) had an underlying condition…Among the 157 cases between 2-4 years of age, 65 (41.4%) had an underlying health condition”. The steep increase in severe disease between 6 months and 4 years suggests that the 46-47 recommended doses of the 14 vaccines (including influenza vaccine) recommended for infants/children 2 months to 4-6 yrs old is a possible factor.
Considering the predicted repeat of last year’s circulating influenza viruses and consequent likelihood that even fewer Canadians than usual will be infected by them, it’s ironic and curious that everyone is being urged to have a flu shot and extraordinarily risky measures have been recommended.
* One of the two influenza vaccines which will not be used in the “free” clinics is Sanofi Pasteur’s Fluzone®. In Canada this vaccine is recommended for people 6 months and older and contains a total of 45 micrograms of haemagglutinin (HA) per 0.5 ml dose (HA is an influenza virus surface protein which can stimulate the immune system to produce antibodies). In USA, another version, Fluzone High-Dose® is available for use in those 65 yrs and older. It contains 180 micrograms of HA per 0.5 ml dose, an amount four times greater than that in Canada’s Fluzone®. The excuse for this excessive amount of stimulant is that, without it, seniors’ immune systems are usually too weak to produce enough antibodies for vaccine efficacy. (Recall that the immune systems of Canada’s seniors will be hyper-stimulated by the squalene-based adjuvant, MF-59 contained in Fluad®.) But the Fluzone High-Dose® monograph admits, “There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose®.” And it’s not surprising that, compared to Fluzone®, Fluzone High-Dose® produces more adverse reactions, especially serious ones.