EU approves updated and expanded Gardasil labeling
- The EU has approved updated labeling for the human papillomavirus (HPV) vaccine, Gardasil, as Sanofi Pasteur will presented new long-term data showing its efficacy against HPV 6,11,16 ,and 18.
- The new immunogenicity and effectiveness data covers long-term follow-up studies involving the men and women who were involved in the original clinical trials, in addition to boys and girls between the ages of nine and 15 who were part of the immune-bridging studies.
- These studies have revealed that there have been no cases of HPV 6,11,16, or 18 among inoculated patients.
Most of the EU countries have cervical cancer/HPV vaccination programs in place for girls. As of this month, Austria even has a program in place for both girls and boys.
Gardasil, which was launched in 2006, is the most widely used HPV vaccine in the world. New long-term data will most likely increase its use and perhaps encourage other countries to adopt vaccination programs for boys as well.
- Pharma Times EU OKs Gardasil update on long-term HPV protection