The European Committee for Medicinal Products for Human Use delivered a positive opinion for a two-dose schedule for the Gardasil HPV vaccine in boys and girls ages 9 through 13.
The license application is supported by a study that demonstrated antibody levels one month after a two-dose schedule (0, 6 months) of Gardasil in 243 girls aged 9-13 years are non-inferior to the ones observed one month after a three-dose schedule (0, 2, 6 months) in 272 women 16-26 years old, the population in which efficacy has been demonstrated.
A CHMP positive opinion is one of the final steps before a final marketing authorization decision is made by the European Commission.
Gardasil, sponsored by Sanofi Pasteur MSD, is the only quadrivalent HPV vaccine. It is Europe’s leading HPV vaccine with 29 million doses distributed in Western Europe and approximately 144 million doses distributed worldwide.
It is currently licensed as a three-dose vaccination schedule at 0, 2, and 6 months in both girls and boys from the age of 9 years, for the prevention of cervical cancer causally related to certain oncogenic HPV types.
Health Canada approved the Aptima HPV 16 18/45 genotype assay for use on the Panther system, both developed by Hologic Inc. The assay is the only approved test for genotyping human papillomavirus types 16, 18 and/or 45 in Canada.
Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of women with normal cytology, it is the third most common HPV genotype associated with invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.
Health Canada has approved the test for two uses: in patients 21 years and older with atypical squamous cells of undetermined significance cervical cytology results, the assay can test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. The assay can also test samples from women 30 years and older with Aptima HPV assay positive results.
The assay received FDA approval on Hologic’s Tigris system in October 2012 and the Panther system in November 2013.
