State actions on human papillomavirus vaccine proposals

Feb 25 2007

The following highlights recent news of state actions on human papillomavirus vaccine proposals. Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases.

FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. GSK in April plans to file for FDA approval of Cervarix, and it expects approval by the end of this year. CDC has added Gardasil to its Vaccines for Children Program, which provides no-cost immunizations to children ages nine to 18 covered by Medicaid, Alaska Native and American Indian children, and some uninsured and underinsured children (Kaiser Daily Women's Health Policy Report, 2/12). Summaries appear below.

• Arkansas: The Cervical Cancer Task Force of Arkansas recently recommended mandating girls in the state receive an HPV vaccine, but members of the task force last week said a mandate was a long-term goal, the Arkansas Democrat-Gazette reports. Jim Phillips, director of infectious diseases for the state's Health Division, said the division would not ask the Arkansas Board of Health to include Gardasil in its list of required immunizations in part because of a concern that adding an HPV vaccine to the list would cause more parents to opt out of other vaccine requirements. Phillips added that the division is recommending that the state educate the public about the HPV vaccine before making it mandatory. Richard Hughes, a member of the Arkansas Board of Health who represents health consumers, said the Health Division is moving too slowly and last week during a meeting of the Cervical Cancer Task Force voiced his objections to delaying a mandate. Phillips estimated that it would cost the state about $1 million to immunize girls not covered by federal programs or private health insurance (Smith, Arkansas Democrat-Gazette, 2/17).
• Connecticut: James Hadler, head of the Department of Public Health's infectious disease division, on Tuesday at a public health committee hearing recommended that lawmakers delay mandating HPV vaccination for at least two years to ensure the vaccine is affordable, safe and accessible, the Hartford Courant reports (Waldman, Hartford Courant, 2/22). A bill (HB 6085), introduced by Rep. DebraLee Hovey (R), would require all girls in the state to receive an HPV vaccine by age 12. It also would give an unspecified amount to the health department to study cervical cancer prevention and treatment options, as well as allocate $50,000 for a public education campaign. Another bill (HB 5485), sponsored by Rep. Roberta Willis (D), would require the state's HUSKY insurance program for low-income families to cover HPV vaccines. Another bill would require the health department to develop HPV immunization standards (Kaiser Daily Women's Health Policy Report, 2/1). "Some vaccines have been show to have unanticipated side effects when they go into wide use during the first year," Hadler said. Hovey said some families who are not educated about the HPV vaccine might not get vaccinated, adding that mandating vaccination "is good public policy" (Hartford Courant, 2/22).
• Florida: Sen. Mike Fasano (R) on Monday said he would delay for one year a measure (SB 660) he sponsored that would require 11- and 12-year-old girls in the state to be vaccinated against HPV, the AP/Bradenton Herald reports. The legislation would have required enforcement of the requirement beginning in the 2008-2009 school year but Fasano's amended proposal require enforcement beginning in the 2009-2010 school year. According to the AP/Herald, Fasano is delaying the measure because of concerns over the vaccine's long-term safety and parents' concerns about discussing HPV with their daughters before they are ready. The bill would allow parents to opt out of the requirement if they could prove they had received information about HPV and cervical cancer. It also includes $16 million in state funds to enable health clinics to offer the vaccine at no cost. A similar measure (HB 561), sponsored by Rep. Ed Homan (R), that would require HPV vaccination beginning in the 2008-2009 school year is under consideration in the House (Royse, AP/Bradenton Herald, 2/19).
• Georgia: Sen. Don Balfour (R) last week introduced a bill (SB 155) that would require that all girls receive an HPV vaccine before entering the sixth grade, the Savannah Morning News reports. The bill allows parents or guardians with religious objections to opt their child out of the vaccine if they provide school officials with an affidavit -- as is required to be exempt from other immunizations. The measure also allows an exemption for parents or guardians who cannot afford the vaccination. The state Department of Human Resources has requested $4.3 million in next year's budget plan to pay for more than 42,000 doses of HPV vaccine for underinsured families (Eckenrode, Savannah Morning News, 2/15).
• South Dakota: The House on Tuesday voted 61-9 to approve a bill that would authorize $9.2 million in funding to provide HPV vaccines at no cost to girls and women ages 11 to 18, the AP/Yankton Daily Press & Dakotan reports (Brokaw, AP/Yankton Daily Press & Dakotan, 2/21). Gov. Mike Rounds (R) last month announced the voluntary program, and Health Secretary Doneen Hollingsworth said that it likely will focus on girls ages 11 and 12 in future years (Kaiser Daily Women's Health Policy Report, 1/10). The measure would provide to the South Dakota Department of Health $400,000 in state funds, $1.3 million in Department of Social Services funds and $7.5 million in federal funds for the vaccination program. The legislation now goes to the Senate (AP/Yankton Daily Press & Dakotan, 2/21).
• Texas: The House Public Health Committee on Wednesday voted 6-3 to pass a bill (HB 1098), sponsored by Rep. Dennis Bonnen (R), that would overturn Gov. Rick Perry's (R) executive order requiring that all girls receive an HPV vaccine, the Houston Chronicle reports (Elliott, Houston Chronicle, 2/22). Perry on Feb. 2 signed an executive order mandating HPV vaccination for girls entering the sixth grade beginning in September 2008 (Kaiser Daily Women's Health Policy Report, 2/21). The full House will not consider the bill until March 12 or later, according to the Dallas Morning News (Ramshaw, Dallas Morning News, 2/22). The committee on Wednesday also voted 9-0 to pass a bill (HB 146), sponsored by Rep. Joe Deshotel (D), that would require the Texas Department of State Health Services to develop a program to educate the public about HPV, the Chronicle reports (Houston Chronicle, 2/22). In related news, documents obtained by the Associated Press indicate that Perry's Chief of Staff Deidre Delisi and aides discussed Gardasil on Oct. 16, 2006, the same day that Merck's political action committee donated $5,000 to Perry's campaign and $5,000 total to eight Texas lawmakers, the AP/Houston Chronicle reports. The documents also show that Perry aides met with Merck lobbyists beginning in mid-August 2006. Robert Black, a Perry spokesperson, on Wednesday said the timing of the meeting and donations were coincidental, adding that there was "no discussion of any kind" on mandating Gardasil during the October 2006 meeting (Austin Peterson, AP/Houston Chronicle, 2/21).
• Virginia: The General Assembly this week approved bills that would require girls entering the sixth grade beginning Oct. 1, 2008, receive an HPV vaccine, the Richmond Times-Dispatch reports. The legislation would allow parents to opt their daughters out of the mandate (Smith, Richmond-Times Dispatch, 2/22). The Virginia General Assembly is the first legislature in the country to pass an HPV vaccination mandate, the AP/Newport News Daily Press reports. The legislation now goes to Gov. Tim Kaine (D). Kaine spokesperson Kevin Hall said Kaine is "supportive of expanded access to this vaccine and thinks efforts to fight cervical cancer are critically important, but he would like to fully review the opt-out provisions that are in this legislation." Kaine has allocated $1.4 million in his budget to expand access to HPV vaccines at local health departments (Potter, AP/Newport News Daily Press, 2/21).