FluMist® live virus nasal spray vaccine was licensed in 2010 for use by Canadians 2-59 yrs old. Health Canada’s licensing information about it’s manufacture tells us (section 3.1.1. General Information) that wild-type influenza viruses are first cultured in eggs, then genetically engineered to produce the FluMist® viruses which have combined properties of wild-type virus and lab-altered, cold-adapted virus. The cold-adaption allows the virus to replicate efficiently at 25°C, a temperature common to the nasopharynx but too low to allow efficient replication of wild-type influenza A and B (which prefer temperatures of 39°C and 37°C respectively, common to the lungs). The expected outcome is, “a protective immune response without causing clinical disease.”
But despite this, the evidence provided in Table 1, pgs 6-7 of the AstraZeneca FLUMIST® 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).
(Note that parents of young children might be confused by evidence found by Osterholm et al published in their 2012 University of Minnesota analysis that live virus influenza vaccine (LAIV) has relatively high efficacy in babies and children 6 months to 7 years of age. But, as the authors explain on page 21, efficacy is only a measure of antibody response found in vaccine trials and isn’t the same as effectiveness in the real world.)
Adults especially, might be interested in an article titled, ‘Important Safety Information’ [no longer on the Internet, but can be viewed here] on AstraZeneca’s FlumistCanada website for healthcare professionals. Stated in the last paragraph (and duplicated on page 4 of their monograph), is the warning: “If Guillain-Barré syndrome occurred within 6 weeks of any prior influenza vaccination or if an individual is immunosuppressed, the decision to give FluMist® should be based on careful consideration of the potential benefits and risk.” VRAN hopes that individuals who’ve suffered from Guillain-Barré syndrome following influenza vaccination would recall the incompetence of influenza vaccines and err on the side of caution, no matter how willing a healthcare professional is to ignore the potential for an adverse reaction and administer the vaccine.
The 2011 statement by the National Advisory Committee on Immunization (NACI) concerning LAIV recommends that, “TIV [trivalent injected influenza vaccine], instead of LAIV, should be used for healthcare workers providing care to individuals with immune compromising conditions, unless the healthcare worker will only accept LAIV. If a healthcare worker or other person receives LAIV and is providing care to individuals with severe immune compromising conditions (defined as hospitalized and requiring care in a protected environment), they should wait two weeks following receipt of LAIV before continuing to provide care to such individuals.” (Note that FluMist® is a more expensive vaccine than the recommended injected vaccine.) Adding the obvious, NACI warns that furthermore, “FluMist® should not be administered to persons with immune compromising conditions, due to underlying disease and/or therapy” explaining that, “Studies on FluMist® have shown that vaccine virus can be recovered by nasal swab in children and adults following vaccination (i.e. ‘shedding’).” Related to this are the monograph warnings: “FLUMIST should be given to pregnant women only if clearly needed.” and, “It’s not known whether FLUMIST is excreted in human milk…caution should be exercised if FLUMIST is administered to nursing mothers.” Considering how poorly effective FluMist® and other influenza vaccines are, why would any of them be “clearly needed”, especially for pregnant women. And how cautious is it to go ahead and vaccinate a nursing mother without having any information about possible risk to her nursing child?
The NACI has much to say about the use of LAIV in children with asthma and, again, waffles about the need for restrictions. It states: “NACI recommends that LAIV can be used in children 24 months and older with stable, nonsevere asthma and in children with chronic health conditions (excluding those with immune compromising conditions and severe asthma).” It feebly continues, “Based on expert review, it is expected that LAIV should be as safe, immunogenic and efficacious in immune competent children with chronic health conditions as it is in healthy children. At this time there is insufficient evidence available to prefer LAIV over TIV in children with chronic health conditions.” It struggles: “LAIV is not recommended for children with immune compromising conditions or those with severe asthma (as defined as currently on oral or high dose inhaled glucocorticosteriods or active wheezing) or those with medically-attended wheezing in the 7 days prior to vaccination, but can be given to children with stable, non-severe asthma.” (Note that an analysis of a 2003 Canadian health survey found 80% more asthma flare-ups in flu shot recipients and a 2012 study from Mayo Clinic found flu shots provided no protection against hospitalization of children, especially those with asthma. In fact, it found a threefold increased risk of hospitalization for children who’d received flu shots. If a killed virus influenza vaccine can do this, what is a live virus one such as FluMist® likely to do?)
Noting some of the questionable ingredients, page 4 of the FluMist® monograph warns: “FLUMIST® is contraindicated in individuals with a history, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or to any other ingredients.” Considering the close proximity of the nasal cavities to the brain and the incomplete blood/brain barrier of children younger than 2-3 yrs old, the excitotoxin, MSG, is another ingredient which should cause concern. As well as Guillaine-Barré Syndrome and anaphylaxis, pg 10 of the monograph lists other serious reactions reported post-marketing: 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.”
Whereas vaccination with FluMist® alone is obviously not without risks, what are the risks of receiving other drugs/vaccines at the same time? Table 3 on pg 11 of the monograph notes that, due to a risk of Reye’s Syndrome, concurrent administration with aspirin should be avoided in those under 18 yrs and aspirin should be avoided until 5 weeks following vaccination. However, trials studying concurrent administration of FluMist® and measles, mumps, rubella and varicella (chickenpox) vaccines found, “Adverse events were similar to those seen in other clinical studies with FLUMIST.” – not inspiring results and dubious, considering the studies were examining concurrent administration of a total of six to seven types of living viruses which might be able to recombine within children’s bodies into new, more infectious pathogens.
Finally, for vaccine administrators and taxpayers who fund “free” vaccines, packaging and storage is an issue. Page 13 of the monograph tells us that FluMist® is supplied in pre-filled single-use glass sprayers which must be stored “in a refrigerator (2°C-8°C) upon receipt and until use. DO NOT FREEZE. Use the product as indicated by the expiration date on the sprayer label.” At the beginning of the influenza season in 2012, Albertans were informed that “free” FluMist® which had been purchased for 2-17 yr olds was being made available to anyone 2-59 yrs eligible and willing to receive it. Chief MOH, Dr James Talbot explained that, by early November, only 25% of the FluMist® taxpayers had funded had been accepted and that LAIV has a shorter shelf life than TIV.