CDC Advisory Committee On Immunization Practices Votes For Permissive Use And For Vaccines For Children Funding For GARDASIL(R) For Boys And Young Men

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Pediatrics / Children's Health;  Immune System / Vaccines
Article Date: 22 Oct 2009 - 20:00 PDT

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Merck & Co., Inc. announced that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) supports the permissive use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and young men ages 9 to 26, which means that GARDASIL may be given to males ages 9 to 26 to reduce the likelihood of acquiring genital warts at the discretion of the patient's health care provider. The ACIP also voted to recommend that funding be provided for the use of GARDASIL in males through the Vaccines for Children (VFC) program.

On October 16, the Food and Drug Administration (FDA) approved GARDASIL for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11, making GARDASIL the only HPV vaccine approved for use in males. GARDASIL is also the only HPV vaccine that protects against HPV types 6 and 11 which cause approximately 90 percent of all genital warts cases.

"We are pleased that the ACIP has provided VFC funding for the use of GARDASIL in males, which should enable access to this important public health advance," said Mark Feinberg M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines and Infectious Diseases. "We remain committed to helping to prevent HPV-related diseases in both males and females."

For females, the ACIP also voted to recommend vaccination with either the bivalent or the quadrivalent HPV vaccine for the prevention of HPV 16 and -18 related cervical cancers, precancers and dysplastic lesions, and recommended vaccination with the quadrivalent HPV vaccine, GARDASIL, for the prevention of cervical, vulvar and vaginal cancers, precancers and dysplastic lesions due to HPV types 16 or 18, and for prevention of genital warts due to HPV types 6 or 11.

GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases and up to 50 percent of vulvar cancer cases. Types 6 and 11 cause approximately 90 percent of all genital warts cases.

Approximately 75 to 80 percent of people acquire one or more types of HPV at some point in their lives. Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in the U.S., in both males and females. For most people, the virus will go away on its own. But, for some people who don't clear certain types of the virus, HPV diseases can develop, and there is no way to predict who will or won't clear the virus. It is estimated that one million people in the U.S. will develop genital warts. Some resolve without treatment; but, for those that require treatment, warts recur in at least 25 percent of cases.

CDC adds GARDASIL to Vaccines for Children (VFC) program

During today's meeting, the ACIP also voted to add GARDASIL to the CDC's VFC program. Since 1994, the VFC program has provided vaccines to children through the age of 18 who are Medicaid-eligible, uninsured, underinsured1 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 continues to support broad access to GARDASIL

The federally funded VFC program, if available, can provide free vaccines to eligible children through the age of 18. To address any funding challenges that may impede access to GARDASIL for people who are not in the VFC eligible age-range, starting November 1 the Merck Vaccine Patient Assistance Program (MVPAP) will be extended to cover 19-26 year old uninsured males. The MVPAP, which was established in 2008 to add adult vaccines to Merck's Patient Assistance Program (PAP), currently provides GARDASIL free of charge to women 19-26 years old who meet the program criteria and who, without assistance, could not afford the vaccine.

Before the end of this year, Merck plans to implement its patient rebate and dose replacement programs for GARDASIL to support access for eligible privately insured males with partial or no coverage for the vaccine. The rebate program for GARDASIL enables eligible privately insured 19-26 year olds whose out-of-pocket costs are over $30 to receive a rebate from Merck for up to a maximum of $130 per dose. The dose replacement program provides a limited number of replacement doses of GARDASIL to eligible health care providers who learn after giving the vaccine to a qualifying patient that their private insurance provides no reimbursement.

About the Advisory Committee on Immunization Practices (ACIP)

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.

Important information about GARDASIL

GARDASIL may not fully protect everyone and does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vaginal and vulvar cancers caused by HPV types 16 and 18.

Select safety information

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and18) Vaccine, Recombinant] is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

GARDASIL is not recommended for use in pregnant women.

The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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 approved in 117 countries

GARDASIL (sold in some countries as SILGARD®) has been approved in 117 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

Source
Merck

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