Merck & Co., Inc. announced that the US Centers for Disease Control and Prevention (CDC) has added Merck's cervical cancer vaccine, Gardasil [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the CDC's Vaccines for Children (VFC) contract for girls and women aged 9 to 18.
Gardasil was approved on June 8 by the Food and Drug Administration (FDA) for use in girls and women ages 9 to 26 years. Gardasil is the world's first and only vaccine available for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.
"The addition of Gardasil to the VFC programme is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of Gardasil in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to Gardasil."
Health insurers covering approximately 94 per cent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse Gardasil. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance programme for vaccines. Through this new programme, currently available in private physicians' offices, Merck is making available, free of charge, Gardasil and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC programme has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC's Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend Gardasil to the VFC programme. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete.
Gardasil is a ready-to-use, three-dose, intramuscular vaccine. 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.
Gardasil is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. Gardasil is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. Gardasil has not been shown to protect against disease due to non-vaccine HPV types.
The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive Gardasil should continue to undergo cervical cancer screening per standard of care.
Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 per cent among recipients of Gardasil and also greater than those observed among recipients of placebo, respectively, were pain (83.9 per cent vs. 75.4 per cent), swelling (25.4 per cent vs. 15.8 per cent), erythema (24.6 per cent vs. 18.4 per cent), fever (10.3 per cent vs. 8.6 per cent), nausea (4.2 per cent vs. 4.1 per cent), pruritis (3.1 per cent vs. 2.8 per cent) and dizziness (2.8 per cent vs. 2.6 per cent).