Gardasil [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine], the cervical cancer vaccine from Merck and Co., Inc, has been granted a license by the European Commission.
Gardasil has been approved as the first and only vaccine in the European Union (EU) for use in children and adolescents aged 9 to 15 years and in adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasias/precancers [cervical intraepithelial neoplasia (CIN 2/3)], high-grade/precancerous vulvar dysplastic lesions (VIN 2/3) and external genital warts (condyloma acuminata) caused by human papillomavirus (HPV) types 6, 11, 16 and 18. This license applies to the 25 countries that are members of the EU, including the five largest, which are France, Germany, Italy, Spain and the UK, a Merck release stated.
Gardasil will be marketed by Sanofi Pasteur MSD (SPMSD), a joint venture between Sanofi Pasteur and Merck and Co., Inc, in 19 European countries including 15 in the EU. In the remaining Central and Eastern European countries, Merck Sharp and Dohme as either Gardasil or Silgard will market GARDASIL.
Cervical cancer is the second most common cause of death from cancer (after breast cancer) among young women (15 to 44 years) in Europe. Approximately 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year (40 each day) in Europe.
On June 8, the US Food and Drug Administration approved GARDASIL to prevent cervical cancer and vaginal and vulvar pre-cancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18. GARDASIL is approved in the United States for 9- to 26-year-old girls and women. Gardasil is also approved for use in several countries throughout the world including Mexico, Australia, Canada, New Zealand, Brazil and two countries in Africa. Additional applications for Gardasil are currently under review with regulatory agencies in more than 50 countries around the world. Additionally, Merck is actively working to accelerate the availability of Gardasil in the developing world: in December, Merck announced a partnership with India's Council of Medical Research to study Gardasil. Merck is also working with PATH and the Gates Foundation to develop HPV vaccination programs that will facilitate the introduction of Gardasil to the most impoverished nations. Merck will make our new vaccines, including GARDASIL, available at dramatically lower prices to developing world countries.