Par quel tour de passe-passe la FDA approuve-t-elle le Gardasil pour les femmes de 27 à 45 ans alors que Merck le fabricant reconnaît dans sa Notice que le Gardasil n’a fait preuve d’aucune efficacité après l’âge de 26 ans !

La Dame Buzyn répondra-t-elle à la question ?

https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

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GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. [See Clinical Studies(14.7).]
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14.7 Studies in Women 27 through 45 Years of Age
Study 6 evaluated efficacy in 3253 women 27 through 45 years of age based on a combined endpoint of HPV 6-, 11-, 16- or 18-related persistent infection, genital warts, vulvar and vaginal dysplastic lesions of any grade, CIN of any grade, AIS, and cervical cancer. These women were randomized 1:1 to receive either GARDASIL or AAHS control. The efficacy for the combined endpoint was driven primarily by prevention of persistent infection. There was no statistically significant efficacy demonstrated for CIN 2/3, AIS, or cervical cancer. In post hoc analyses conducted to assess the impact of GARDASIL on the individual components of the combined endpoint, the results in the population of women naïve to the relevant HPV type at baseline were as follows : prevention of HPV 6-, 11-, 16- or 18-related persistent infection (80.5% [95% CI : 68.3, 88.6]), prevention of HPV 6-, 11-, 16- or 18-related CIN (any grade) (85.8% [95% CI : 52.4, 97.3]), and prevention of HPV 6-, 11-, 16- or 18-related genital warts (87.6% [95% CI : 7.3, 99.7]).
Efficacy for disease endpoints was diminished in a population impact assessment of women who were vaccinated regardless of baseline HPV status (full analysis set). In the full analysis set (FAS), efficacy was not demonstrated for the following endpoints : prevention of HPV 16- and 18-related CIN 2/3, AIS, or cervical cancer and prevention of HPV 6- and 11-related condyloma. No efficacy was demonstrated against CIN 2/3, AIS, or cervical cancer in the general population irrespective of HPV type (FAS any type analysis).

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