VRBPACVaccines and Related Biological Products Advisory Committee
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As a result, the overwhelming majority of the "CIN 2/3 or worse"cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil[TM] HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC Meeting must have been CIN 2 lesions.
In view of the pending review of Merck's new application for expanded use of Gardasil[TM] as a vaccine to prevent "anal dysplasia and cancer" in both men and women, Erickson also sent a letter to all members of the VRBPAC, requesting the Committee to use appropriate primary endpoint and reliable HPV genotyping methods to evaluate the efficacy of the vaccine, based on the same scientific arguments put forth in the letter addressed to the FDA Commissioner.
The hemagglutinin of most influenza A (H1N1) and A (H1N2) viruses were related antigenically to A/New Caledonia/20/99; therefore, VRBPAC recommended that an A/New Caledonia/20/99 (H1N1) virus be retained in the 2002-03 vaccine.
Consequently, VRBPAC recommended that the influenza B component be updated for the 2002-03 vaccine to an influenza B/Hong Kong/330/01-like virus.
Therefore, VRBPAC recommended changing the A (H1N1) vaccine strain to A/New Caledonia/20/99-like (H1N1) virus.
Therefore, VRBPAC recommended retaining B/Beijing 184/93-like virus for the 2000-01 vaccine.
For the United States, VRBPAC recommended retaining a B/Beijing/184/93-like virus for the vaccine.
Therefore, VRBPAC recommended retaining A/Nanchang/933/95 in the 1997-98 influenza vaccine.
Because vaccines containing the Aftexas/36/91 strain induced antibodies with similar frequency and titer to both the vaccine virus and to recent type A(hlnl) strains (1), VRBPAC recommended retaining an Aftexas/36/91-like strain in the 1996-97 vaccine.