During their review of Gardasil by the FDA, the efficacy of the vaccine was also evaluated on individuals who were exposed to the oncogenic HPV strains before vaccination since individuals who are non-naïve will also receive the vaccination. A concern was raised for disease enhancement (increase in CIN 2/3, cervical adenocarcinoma in situ or worse) in this subgroup (5). In these individuals, the efficacy was -25.8% (95% CI: -76.4, 10.1%) (5). Thus, vaccination with Gardasil of non-naïve individuals who had HPV 16/18 oncogenes before vaccination showed a higher level of premalignant cell changes than did placebo.
I cannot understand how this vaccine has been allowed without exception, at least pretest individuals to see if they have been exposed before.
During their review of Gardasil by the FDA, the efficacy of the vaccine was also evaluated on individuals who were exposed to the oncogenic HPV strains before vaccination since individuals who are non-naïve will also receive the vaccination. A concern was raised for disease enhancement (increase in CIN 2/3, cervical adenocarcinoma in situ or worse) in this subgroup (5). In these individuals, the efficacy was -25.8% (95% CI: -76.4, 10.1%) (5). Thus, vaccination with Gardasil of non-naïve individuals who had HPV 16/18 oncogenes before vaccination showed a higher level of premalignant cell changes than did placebo.
I cannot understand how this vaccine has been allowed without exception, at least pretest individuals to see if they have been exposed before.
During their review of Gardasil by the FDA, the efficacy of the vaccine was also evaluated on individuals who were exposed to the oncogenic HPV strains before vaccination since individuals who are non-naïve will also receive the vaccination. A concern was raised for disease enhancement (increase in CIN 2/3, cervical adenocarcinoma in situ or worse) in this subgroup (5). In these individuals, the efficacy was -25.8% (95% CI: -76.4, 10.1%) (5). Thus, vaccination with Gardasil of non-naïve individuals who had HPV 16/18 oncogenes before vaccination showed a higher level of premalignant cell changes than did placebo.
I cannot understand how this vaccine has been allowed without exception, at least pretest individuals to see if they have been exposed before.