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BioCryst Pharmaceuticals, Inc. Message Board

  • left2rightdoor left2rightdoor Jan 28, 2013 2:47 AM Flag

    ACIP discussions of vaccines based on non-inferiority Oct 24-25 pp 154 et seq

    Quadrivalent vaccine induced statistically non-inferior GMTs and seroconversion rates to each A strain (H1N1 and H3N2) and each B-lineage strain (Brisbane and Florida) compared with each control trivalent vaccine containing the respective strains in 35 of 36 analyses in adults, elderly, and children. Among subjects ≥ 65 years of age, the seroconversion rate for A/H1N1 was 4% lower in the quadrivalent vaccine group than in the control trivalent vaccine group. This was marginal and should have no clinical ramifications, given that non-inferiority of the GMT was achieved and that the seroprotection rate against this strain was 91%. Further, quadrivalent vaccine induced statistically superior GMTs and seroconversion rates to each B- lineage strain compared with each control trivalent vaccine not containing the respective strain in 15 of 16 analyses in elderly and children. Among subjects 65 years, the GMT for B/Brisbane was 74 in the quadrivalent group and only 42 in the comparative group. This should have no clinical consequences, given that the immunological endpoints were non-inferior and superiority was achieved for seroconversion rates of that strain. In conclusion, sanofi pasteur developed Fluzone® QIV to address the co-circulation of the two B lineages, the history of frequent mismatches, and the limited protection afforded by trivalent vaccine against the mismatched B strain as expressed by VRBPAC and others. Fluzone® QIV has the same safety and immunogenicity profiles as the currently licensed Fluzone® TIV, plus the additional protection for the second B strain. Also, Fluzone® QIV may be particularly helpful for children because of their lack of exposure to influenza viruses and limited ability to mount cross reactive antibody responses to the alternate B lineage. Therefore, it makes sense to transition to quadrivalent vaccine over the next few years. sanofi pasteur distributes over 40% of all influenza vaccines used in the US.

 
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