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More H1N1 Low Reactors In Japan Raises Vaccine Concerns
Recombinomics Commentary 18:30
August 8, 2011

This weekend the NIID in Japan released a series of H1N1 sequences, including 40 HA sequences from 2011.  Like earlier releases, these sequences had a large number of changes at positions 156-159 which are associated with LOW REACTOR results when tested against the current H1N1 vaccine directed against California/7/2009. The latest series had 14 changes at positions 156-159 with a distribution of 5, 5, 3, 1.  The earlier sets of sequences where dominated by changes at position 158 (6, 1, 9, 2 and 1, 3, 5, 1).  This changing profile indicates these low reactor changes are present in the clinical sample and not due to random mutations selected by the cell line used to isolate H1N1 virus, as suggested by the CDC in the FDA’s vaccine advisory committee meeting.  The committee discounted the low reactor changes reported by other WHO regional centers, such as Mill Hill in England and voted unanimously to leave all three vaccine targets unchanged, for the 2011/2012 flu season in the northern hemisphere.  This vaccine, which is identical to vaccine for the 2010/2011 season, will soon be shipping throughout the northern hemisphere, raising concerns that the vaccination program will fail.

This concern was increased by recently released sequences (by the CDC at GISAID), which included a construct of a new H1N1 target using H1 and N1 on a PR8 genetic background, as well as three new H3N2 targets and three new influenza B targets, indicating the CDC now has major reservations of use of 2009 targets.  The new constructs largely use 2010 isolates, like A/South Carolina/02/2010 for the H1N1 target..  The H1N1 target also has K157E and Q226R acknowledging a need for changes in these two critical regions.  Two way testing of the new H1N1 target was listed as LOW / FAIL indicating the old vaccine poorly recognized the new target, and a vaccine against the new target poorly recognized the old target (Califorenia/7).

The latest data from Japan once again highlights the reliance of the CDC and WHO on the paradigm of random mutations to be hazardous to the world’s health.  The recommendations to WHO and the FDA in the United States was largely based on the assumption that the frequent detection of changes at positions 156-159 was due to lab selection of random mutations, as well as similar changes at positions 225 (D225G and D225N) and 226 (Q226R).  the testing of new H1N1 targets with changes at positions 157 and 226 acknowledges that the “lab errors” due to “spontaneous mutations” was false.  However in the southern portion of the United States the new school year begins this week and more school seasons will begin later this month in areas to the north.

Last season pneumonia and influenza death rates were at record levels, and the recent results from Japan raises concerns that changes at positions 156-159 will lead to immunological escape, and changes at positions 225 and 226 will target the lungs, leading to more severe H1N1 cases.

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