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Paradigm Shift Intervention Monitoring
The above comments once again raise serious concerns about the lab manipulated data used to select influenza vaccine targets. In 2011 the US Pneumonia and Influenza (P&I) death rate was a record levels which were similar to rates in 2008. In 2008 the vaccine mismatches for all three targets was acknowledge and all three were changed for the 2008/2009 season in the northern hemisphere. In 2011 the clear mismatches were denied and as indicated above, the targets for the 2011/2012 season remained unchanged.
These decisions are largely dependent on the anigen characterization tests which test new influenza isolates against antisera directed against the current vaccine targets. This assay can be heavily manipulate at both ends of the assay, the creation of reference antisera as well as the procedures for the isolation of virus from new infections.
Sequence data has revealed dramatic inconsistencies in the assays, where identical sequences can signal the presence or absence of low reactors (isolates that reduce the titer 4 fold or more). The data for pandemic H1N1 has been striking, in part because of a significant increase in public H1N1 sequences coupled with a target that has remained unchanged since the first target was selected in the spring of 2009. The H1N1 has clearly evolved away from the initial sequences leading to more severe outbreaks in countries which were subjected to significant outbreaks in the prior season.
The detection of low reactors has been strongly linked to changes at positions 157-160 which have repeatedly produced high frequencies of low reactors, especially in more recent isolates. However, changes at these positions as well as receptor binding domain changes are heavily dependent on virus isolation procedures. Moreover, such changes can also target gal 2,3 receptors present in chicken eggs as well as human lung. Virus isolation using mammalian cells rich in gal 2,6 receptors can select away from the changes that create low reactor results and target human lung, but such isolates are used to justify continued use of the older targets.
This bias, as well as under-reporting of H1N1 due to a lack of testing or use of the intensity “rapid test" is somewhat limited in the pneumonia and influenza death rate, which does not require lab confirmation. This rate also signals immunological escape which leads to more infections and deaths. Thus, the high death rate in 2011, like the similar rate in 2008, signals a need to change the vaccine targets. The failure to change any of the targets for the 2011/2012 raises serious questions about the assays and consultants used by the FDA and WHO in the selection of targets, which this season were unchanged by committees representing most agencies. Thus, the worldwide targets for the 2011/2012 season are the same and unchanged from the prior season (and the H1N1 target is the same as 2009, A/California/07/2009).
The latest FDA approval once again indicates that an independent scientific review of the committees and procedures associated with influenza vaccine target selection is long overdue.