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NCSD Applauds FDA Approval of Nine-Valent Human Papillomavirus (HPV) Vaccine

More effective HPV vaccine protects against 90 percent of cervical, vulvar, vaginal, and anal cancers; NCSD urges health care providers to scale up vaccination implementation
Release Date: 
Friday, December 12, 2014

For Immediate Release                                               Contact:
December 12, 2014                                                     Stephanie S. Arnold Pang
                                                                                         National Coalition of STD Directors 
                                                                                         (612) 220-24446
                                                                                         sarnold@ncsddc.org 

PRESS RELEASE 

Washington, D.C. – The National Coalition of STD Directors (NCSD) applauds FDA approval of Gardasil 9, an HPV vaccine developed by Merck that protects against nine types of HPV.  This nine-valent vaccine improves upon the Merck Vaccines’ current quadrivalent vaccine by providing protection from five additional types of HPV and preventing approximately 90 percent of cervical, vulvar, vaginal, and anal cancers as well as providing protection from two types of HPV that cause approximately 90 percent of genital warts cases.

“The development and approval of the nine-valent HPV vaccine is a major advancement in preventing the transmission of HPV.  With this vaccine, virtually eradicating cervical, anal, and other genital cancers as well as genital warts within a generation is possible if actual scale up in vaccination occurs,” stated William Smith, Executive Director of NCSD.

HPV causes 90 percent of cervical cancer which is the third most common type of cancer among women worldwide.  In addition, HPV also causes 90 percent of anal cancers and 70 percent of vaginal and vulvar cancers.  Gardasil 9 will provide protection from seven cancer-causing types of HPV (16, 18, 31, 33, 45, 52, and 58) that cause approximately 90 percent of cervical, vulvar, vaginal, and anal cancers and two types of HPV that cause approximately 90 percent of genital warts cases (6, and 11).  Gardasil 9 adds protection against five additional HPV types (31, 33, 45, 52 and 58) which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

Despite the high rates of HPV-related disease in the United States, including cervical cancer and genital and perianal warts, previous rollouts of the HPV vaccine have been less than adequate and missed a major public health opportunity to decrease the burden of cervical cancer and other adverse HPV-disease outcomes.  The Centers for Disease Control and Prevention (CDC) reports that approximately 360,000 people in the United States get genital warts each year.  In addition, in 2011, there were approximately 12,000 new cases of cervical cancer in the United States and 4,000 deaths from the disease.  The CDC also estimates that about 3,000 new cases of HPV-associated anal cancers are diagnosed in women and about 1,700 are diagnosed in men each year in the United States.

FDA approved Gardasil 9 for use in females ages 9 through 26 and males ages 9 through 15.  Current CDC HPV vaccination recommendations, while needing to be updated with the release of Gardasil 9 as they reference the Gardasil quadrivalent vaccine, underscore the importance of scaling up HPV vaccination in both females and males.  Currently, the CDC recommends routine HPV vaccination for females and males age 11 or 12 years, and catch-up vaccination for females ages 13-26 and males ages 13-21 years if not previously vaccinated.  A 2013 report showed that girls aged 13 -17 who received the recommended vaccine doses to be a mere 37.6 percent.  For boys aged 13-17, those receiving the recommended vaccine doses was just 13.9 percent.

“We call on all providers seeing patients eligible for this vaccine, including NCSD’s member state and local health departments STD programs doing clinical service delivery, to scale up their implementation of the HPV vaccine,” stated Smith.  “Additionally, policy and educational efforts that further HPV prevention must be undertaken.  We have simply lost too much time already in our fight against HPV and with an improved vaccine, there is a renewed urgency to act and act now,” concluded Smith.

NCSD has a long history working to advance prevention, testing, and treatment of HPV disease, including a survey that is currently in the field assessing HPV related activities in safety net clinics.  In 2013, NCSD and the American Sexual Health Association (ASHA) convened two meetings of stakeholders from the HPV, immunization, and sexual health fields to brainstorm potential policy actions to enhance HPV disease awareness with a particular focus on scaling up vaccination rates. 

In addition, in 2012, NCSD produced an easy to use guide for health care providers about external genital warts (EGWs), a commonly occurring outcome of HPV infection, titled “Straight Talk: Counseling Patients about Extra Genital and Perinatal Warts.”  NCSD has additional materials highlighting how STD programs can increase awareness of HPV disease and promote the HPV vaccine: “STD Programs: Increasing HPV Disease Awareness through Collaboration & Innovation” and “How your STD program can promote the HPV Vaccine” which are available on NCSD’s website.

For more information regarding US Prescribing Information for Gardasil 9, please click here and for Patient Information, please click here.

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 The National Coalition of STD Directors (NCSD) is a partnership of public health professionals dedicated to promoting sexual health through the prevention of STDs. NCSD provides dynamic leadership that strengthens STD Programs by advocating for effective policies, strategies,and sufficient resources by increasing awareness of the medical and social impacts of STDs.For more information, visit www.NCSDDC.org.  

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