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Vaccines for Children (VFC) logo---Dr. Julie Gerberding, Director of the CDC
Merck and GlaxoSmithKline develop vaccines to protect against human papillomavirus (HPV)
On October 6, 2005, Merck
announced that its "Investigational Vaccine GARDASIL™ Prevented 100 Percent of Cervical Pre-cancers and Non-invasive Cervical Cancers Associated with HPV Types 16 and 18 in New Clinical Study."
Two-and-a-half months later, on December 19, 2005, it was
announced that "Cervarix™, [GlaxoSmithKline] GSK's candidate cervical cancer vaccine, formulated with the proprietary adjuvant AS04, induced antibody levels against the two most common cancer-causing HPV types (HPV 16/18) at least two-fold higher in 10-14 year old adolescent girls, than in women 15-25 years old, a new study shows."
Included in that announcement was a statement that "It would be beneficial to vaccinate adolescents against infection with cancer-causing HPV types 16/18 well before the start of sexual activity with a vaccine with sustained efficacy….
"'Vaccination of pre-teen/adolescent girls against cancer-causing HPV before onset of sexual activity will be an important part of the overall strategy for cervical cancer prevention,' said Anna-Barbara Moscicki, MD, Professor of Pediatrics, University of California, San Francisco. 'Prevention of high-risk HPV 16 and HPV 18 infection is key to reducing cervical cancer, and a prophylactic vaccine against these types of HPV is necessary to prevent infection in the first place. The higher levels of antibody titers seen in the vaccinated preteens/teens than the vaccinated adults offers encouraging evidence that in this age group, a stronger immune response could translate into longer protection. Ongoing studies should further demonstrate these findings.'"
Food and Drug Administration approves Merck's Gardasil® for protection against HPV
On June 8, 2006, it was
announced that the "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus."
Advisory Committee on Vaccination Policy (ACIP) endorses use of Gardasil for 11-12 year old girls
Three weeks later, on June 29, 2006, it was
announced that the "CDC’s Advisory Committee Recommends Human Papillomavirus Virus Vaccination."
:"The Advisory Committee on Immunization Practices (ACIP) voted Thursday to recommend that a newly licensed vaccine designed to protect against human papillomavirus virus (HPV) be routinely given to girls when they are 11-12 years old. The ACIP recommendation also allows for vaccination of girls beginning at nine years old as well as vaccination of girls and women 13-26 years old. HPV is the leading cause of cervical cancer in women."
HPV vaccination of young girls runs into opposition
Even before the June 6th FDA approval of Gardasil, voices had been raised in opposition to the idea that Gardasil "be routinely given to girls when they are 11-12 years old." Resistance to using Gardasil is reported on in a June 5, 2006, article from Time Warner's
Fortune, reprinted on Time Warner's
CNNMoney.com web site, under the title
"Merck's $4 billion PR problem--A vaccine to prevent cervical cancer looks set to be a blockbuster -- but resistance from parents and patient advocates could trip it up."
According to that article, the president and co-founder of the National Vaccine Information Center, "[Barbara Loe] Fisher is strongly opposed to Merck's proposals to inoculate girls at age 9, which is six years before the average age of first sexual experience in the United States 'It's just profit-making on the backs of 9-year-old girls,' charges Fisher.
"The proposal has also drawn widely publicized ire from groups like the Family Research Council and Focus on the Family, both Christian conservative organizations generally opposed to anything they believe promotes premarital sex."
advocates for women's health (and reproductive rights) respond to HPV vaccination foes
Advocates for Youth, which describes itself as a group which "champions efforts to help young people make informed and responsible decisions about their reproductive and sexual health," responded to HPV vaccination opponents in a "Media Brief" entitled
"Will the Politics of Teen Sex Stop a Cancer Vaccine?"
In a May 12, 2005, article in
The Nation, poet, feminist, and polemicist Katha Pollitt, in an article entitled
"Virginity or Death!", takes "Christian conservatives" to task on this and the related issue of Plan B, calling their opposition to medical technologies designed to protect the health and expand the reproductive options of women "honor killing on the installment plan" and pointing out that they "have a special reason to be less than thrilled about the HPV vaccine" because:
"With HPV potentially eliminated, the antisex brigade will lose a card it has regarded as a trump unless it can persuade parents that vaccinating their daughters will turn them into tramps, and that sex today is worse than cancer tomorrow. According to
New Scientist, 80 percent of parents want the vaccine for their daughters--but their priests and pastors haven't worked them over yet."
Vaccines for Children program on track to offer Gardasil HPV vaccine
The federally-run-and-funded
Vaccines for Children program:
"helps families by providing free vaccines to doctors who serve eligible children and is administered at the national level by the CDC through the National Immunization Program. CDC contracts with vaccine manufacturers to buy vaccines at reduced rates.
"States and eligible U.S. projects enroll physicians who serve eligible patients up to and including age 18 years, providing routine immunizations with little to no out-of-pocket costs…."
"The VFC program provides immunizations for children who are uninsured, Medicaid recipients, Native Americans, and Alaska Natives at their doctors’ offices. VFC also helps children whose insurance does not cover vaccinations when they are vaccinated at participating federally-qualified health centers and rural health clinics."
In order to determine whether and when HPV vaccinations would be made available to those for whom it is being recommended by the Advisory Committee for Immunization Policy (ACIP),
Etopia Medical News Network spoke today with Curtis Allen, a spokesperson for the Centers for Disease and Control (CDC) in Atlanta, Georgia.
You can listen to that interview, in its entirety, by clicking
here.
According to Mr. Allen, in order for HPV vaccines, such as Merck's Gardasil, to be included under the Vaccines for Children program, five steps are necessary:
1. The Advisory Committee on Immunization Policy (ACIP) must recommend the use of the vaccine for use in children
2. The ACIP must communicate this recommendation to the Vaccines for Children program
3. The Centers for Disease Control must negotiate a contract for provision of the product with its manufacturer(s)
4. The Director of the CDC (currently
Julie Gerberding, M.D., M.P.H.) must review and approve the recommendation
5. Approval of the recommendation by the CDC Director must be published in the CDC's
Morbidity and Mortality Weekly Report (MMWR), its official publication
Also according to Mr. Allen, the first two of these steps have already been completed. Negotiations under Point 3 have not yet begun, he said, but should begin shortly. The CDC Director, he added, has 30 days from the announcement of ACIP's recommendation to review and decide whether or not to approve its finding, which time period ends on July 29, 2006.
You can listen to an excerpt from this interview in which Mr. Allen indicates that CDC has not sensed a "wave of sentiment" opposed to HPV vaccination that is likely to derail its efforts on behalf of this public health measure by clicking
here.
a Current Issues in Immunization NetConference on the issues discussed here from the CDC offers continuing education credits
The National Center for HIV, STD, and TB Prevention, National Center for Chronic Disease Prevention and Health Promotion, and The National Immunization Program today presented "Special Dispatch: Human Papillomavirus (HPV), Cervical Cancer, and HPV Vaccine and Recommendations--A Current Issues in Immunization NetConference." You can get more information about this program by clicking
here.
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