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H1N1 Vaccine: How Well Does It Work in Children?

Posted Nov 12 2009 10:00pm

Not well. Not by a long shot according to government-funded studies. The NIH disguises the bad news in a press release, using this headline: Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu.

Great!? Not.

Here's the deal. After receiving one dose of this year's swine (H1N1) flu vaccine, children developed a theoretically protective level of antibodies to the strain of H1N1 flu isolated in California in July at these rates:

76% of 10 - 17 year olds   [pretty sucky]
36% of 3 - 9 year olds   [dismal]
25% of babies aged 6M to 35M   [atrociously bad]

These data were obtained 8 - 10 days after the vaccination. "It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will ... continue to rise for several weeks following vaccination," states a Dr. Fauci in the NIH press release. My bet: the "continued rise" will be negligible. 

No wonder the CDC was considering giving children two doses of the vaccine. It doesn't work.Was the H1N1 vaccine deemed too dangerous to administer twice to children?

Looking at a different vaccine for perspective, two doses of MMR are given for the same reason. The second MMR shot is not a euphemistically-named "booster," but a re-vaccination of all kids.

This weekend, I had fun reading all the package inserts for the four versions of the H1N1 vaccine -- 3 injectable, and 1 nasal spray. Two notables:
  1. There were no H1N1 2009 studies cited, just seasonal flu vaccine studies, with a note saying that H1N1 was expected to perform like the seasonal flu shot. (If so, why is the H1N1 vaccine being studied?) 
  2. All studies cited in the inserts, with the exception of the nasal spray vaccine package insert, were blood antibody tests following vaccination, exactly like the test results cited at the beginning of this article. Only one of the cited studies - and this is the important point - actually looked at the endpoint the vaccine is designed to prevent: whether or not a vaccinated person who came into contact with the vaccine-strain virus got symptoms or not. In the nasal spray product insert from MedImmune, the endpoint study is summarized as follows: "Effectiveness for any ...endpoints...was not demonstrated in a subgroup of adults 50-64 years of age." And, "Effectiveness was not demonstrated for the primary endpoint [any febrile illness] in adults 18-49 years of age." Then, the section concludes with an unsupported statement, "Effectiveness was shown in a post-hoc analysis using CDC-ILI in the age group 18-49 years." That "post-hoc analysis" is not shown. If you read Evidence of Harm, you know the CDC has given "post-hoc analyses" quite the bad reputation. And, is this effectiveness versus placebo (the injected flu vaccine) or effectiveness versus the non-vaccinated. The insert was not clear.
Assuming the three main objectives of a package insert are to list ingredients, demonstrate safety, and demonstrate effectiveness, wouldn't results of any favorable endpoint studies have been cited in lieu of theoretical antibody studies? Where are the other endpoint studies? Do people actually come down with H1N1 flu symptoms or not after getting the vaccine? The product inserts don't tell us. And, that is my point about the H1N1 antibody study in children. Do the vaccinated kids who mount theoretically-protective antibodies get H1N1 flu symptoms when they come in contact with the virus ... or not?

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