CDC Advisory Committee on Immunization Practices Votes for Expanded Use of GARDASIL® in Boys and Young Men
October 25, 2011 1:17 pm ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to recommend that boys 11 to 12 years old be vaccinated routinely with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] to help prevent anal cancer caused by human papillomavirus (HPV) types 16 and 18, anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV types 6 and 11. Additionally, the Committee recommended that GARDASIL be administered to males 13 to 21 years of age who have not previously been vaccinated or have not completed the three-dose series, and that the vaccination series can be started at age 9 years at the discretion of their physicians.
“Today’s ACIP recommendations will help to provide greater access to GARDASIL for males,” said Mark Feinberg, M.D., Ph.D., chief public health and science officer, Merck Vaccines. “These new recommendations for use in males mark another important step in helping to protect more people from the HPV-related cancers and disease that GARDASIL is indicated to prevent.”
GARDASIL is indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal 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. GARDASIL is also approved for use in boys and men ages 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, for the prevention of anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and for the prevention of genital warts caused by HPV types 6 and 11.
Approximately 75 to 80 percent of people acquire one or more types of HPV at some point in their lives. 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 can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women. There is no way to predict who will or will not clear the virus.
CDC maintains inclusion of GARDASIL in Vaccines for Children (VFC) program
During today’s meeting, the ACIP also voted to maintain the inclusion of GARDASIL in the CDC’s VFC program for both males and females. Since 1994, the VFC program has provided vaccines to children through the age of 18 who are Medicaid-eligible, uninsured, underinsured1 or 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 vaccines
The federally funded VFC program provides free vaccines to eligible children through the age of 18. For people who are not in the VFC eligible age-range, the Merck Vaccine Patient Assistance Program (MVPAP), established in 2008 to add adult vaccines to Merck’s Patient Assistance Program (PAP), currently provides GARDASIL free of charge to women and men 19-26 years old who meet the program criteria and who, without assistance, could not afford the vaccine.
Merck also has a patient rebate program for GARDASIL that supports access for eligible privately insured 19-26 year olds with partial or no coverage for the vaccine. The program 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.
About the 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.
Details of the ACIP recommendations for GARDASIL will be available from the CDC. The recommendations are under review by the director of the CDC and the Department of Health and Human Services and will become official when published in the CDC’s Morbidity and Mortality Weekly Report.
Important information about GARDASIL
GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.
GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.
Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18.
Select safety information for GARDASIL
GARDASIL 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.
About anal cancer and genital warts
Anal cancer affects both men and women. According to the American Cancer Society, it is estimated that approximately 2,000 men and more than 3,000 women were diagnosed with anal cancer in 2010. There is no standardized screening recommended for the general population for anal cancer and many people are diagnosed when the disease is more advanced.
It is estimated that, annually, approximately one million people in the United States develop genital warts. Some resolve without treatment; but, even in those treated, warts recur in at least 25 percent of cases.
GARDASIL is approved in 124 countries
GARDASIL (sold in some countries as SILGARD®) has been approved in 124 countries, and additional applications are currently under review with regulatory agencies in other countries around the world.
About Merck
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Prescribing Information and Patient Product Information for GARDASIL® is available at
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.
GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
1 Underinsured children receive VFC vaccines at Federally Qualified Health Centers.
Merck
Media:
Pam Eisele, 908-423-5042
Jennifer Allen Woodruff, 215-652-0572
or
Investors:
Carol Ferguson, 908-423-5088
