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Paradigm Shift Intervention Monitoring
The military recruits, again, a captive
population, essentially 100 percent immunized and, for the purposes of
this slide, 100 percent immunized with the LAIV. Two sites that did
receive TIV were excluded from this analysis.
We had a very remarkable increase in infections with pandemic H1N1 in recent weeks in our recruits. That is very unusual for us. Highly vaccinated, we do see influenza in that highly vaccinated population. We take those seriously, in case they are breakthroughs to see if there is drift of the circulating strains from the vaccine. But this is very unusual to see so many of late.
The above comments are from the Air Force presentation at the February 25, 2011 Vaccine Advisory Committee meeting to determine targets for the 2011/2012 flu season in the United States. Although the presenter did not characterize the H1N1 generating the significant vaccine breakthrough, in February the Air Force did release 2011 sequences from military dependents who had been vaccinated. One series was from dependents in Korea, but a second series was from dependents in the United States. Both of the sequences from the United States were the Chihuahua sub-clade, raising concerns that the data presented above represents a “herald wave” predicting the dominant sub-clade in the next flu season. The sudden 2011 appearance of the sub-clade in military samples was also seen in recently released 2011 H1N1 sequences by the CDC.
Moreover, the recent WHO 2011 pandemic alert described an H1N1 outbreak in Ecuador at the beginning of 2011 followed by outbreaks in Mexico and Venezuela in March 2011. Public sequences from Mexico, as well as anecdotal reports indicate the dominant H1N1 in all three countries, was the Chihuahua sub-clade with D225N in severe and fatal cases.
Unfortunately, the vaccine committee voted 15-0, with one abstention, to leave the H1N1 vaccine target, A/California/07/2009, unchanged. The lone abstention, Dr Vicki Debold with the National Vaccine Information Center, expressed concerns about the efficacy of the H1N1 vaccine using A/California/07/2009 as the target.
The Air Force testimony, coupled with the detection of the Chihuahua sub-clade in vaccinated hosts, raise serious concerns about the current vaccine, as well as the vaccine recently shipped to the southern hemisphere, as well as the vaccine being prepared for the 2011/2012 season in the northern hemisphere, since all of the above use A/California/07/2009 as the target for all approved vaccines, worldwide.
The current vaccine selection for WHO and the United States is heavily dependent on an antigen characterization test, which has only identified one US low reactor for the entire 2010/2011 season. Similarly, the only US isolates designated as low reactors in the 2009/2010 season had changes at the same position, 159.
These small numbers of low reactors is in marked contrast various sub-clades identified in multiple studies citing vaccine breakthroughs, including the examples presented by the Air Force, which are likely linked to the Chihuahua sub-clade.
Ignoring these important studies and relying on an antigen characterization with serious sensitivity and reproducibility issue jeopardizes the world’s health.
More information on the isolates linked to the dramatic vaccine failures described to the 2010/2011 vaccine selection committee would be useful.