Merck & Co., Inc. announced that the US Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that girls and women 11 to 26 years old be vaccinated with Gardasil [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to prevent cervical cancer, precancerous and low-grade lesions, and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18.
The Committee recommended that Gardasil be administered to 11- and 12- year-old females and to females aged 13 to 26 who have not previously been vaccinated, and that nine- and 10-year-old females can be vaccinated with Gardasil at the discretion of their physicians. The ACIP stated that Pap and HPV screening prior to vaccination are not necessary. The ACIP also recommended that females can receive Gardasil regardless of whether they have or previously had an abnormal Pap test, a positive HPV test or genital warts.
On June 8, the Food and Drug Administration (FDA) approved Gardasil, the only vaccine available in the US for the prevention of HPV types 16- and 18-related cervical cancer, for use in girls and women ages nine to 26 years. Gardasil is a ready-to-use, three dose, intra muscular vaccine. The FDA approved Gardasil for the prevention of cervical cancer; cervical pre-cancers [cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ (AIS)]; vulvar pre-cancers [vulvar intraepithelial neoplasia (VIN) 2/3]; and vaginal pre-cancers [vaginal intraepithelial neoplasia (VaIN) 2/3] caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.
"Merck is pleased that the ACIP has endorsed the use of Gardasil to protect adolescent girls and young women from the potentially serious consequences of HPV infection," said Mark Feinberg, M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines. "Gardasil was specifically designed to reduce the majority of HPV-related clinical diseases, those caused by HPV types 6, 11, 16 and 18, and this recommendation from the ACIP will help to ensure that this vaccine can do just that for many girls and young women."
During the meeting, the ACIP also voted to add Gardasil to the CDC's Vaccines for Children (VFC) programme. Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured and Native American. After the ACIP has made a recommendation for the use of a given vaccine, the Committee votes on whether the vaccine should be included in the VFC program. Eligible children may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine have been completed.
Merck has also created a new patient assistance programme for vaccines. Through this new programme, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck vaccines, including Gardasil, will become available through this programme in the third quarter of 2006.
The ACIP develops written recommendations for the routine administration of vaccines to children and adults, along with schedules regarding the appropriate dosage and dosing frequency, and contraindications applicable to the vaccines. The goals of the Committee, which consists of 15 experts in immunization and related fields, are to provide advice which will assist the CDC and the nation in reducing the incidence of vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products. The ACIP recommendations do not result in requirements for vaccine administration by individual states or coverage by insurance companies. However, state health authorities and private insurers typically follow the Committee's guidance.
Gardasil should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
On June 1, Gardasil was approved in Mexico and on June 16, Gardasil was approved in Australia. Applications for Gardasil are currently under review with regulatory agencies worldwide, including but not limited to agencies in Argentina, Brazil, the European Union, New Zealand, Singapore and Taiwan. 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 programmes that will facilitate the introduction of Gardasil to the most impoverished nations.