In June 2006, the FDA approved a vaccine that prevents four types of human papillomavirus (HPV) in women. The injection is known as Gardasil, which is an abbreviation of “guard against squamous intraepithelial lesions.” When a woman receives Gardasil, she must receive an initial injection, followed by another shot in two months, and a final dose at six months. This completes the vaccination process, which costs about $360. The FDA has also approved the use of Gardasil in males aged 9 to 26 years.
In October 2009, the FDA approved the use of another HPV vaccine, Cervarix, in females aged 10 to 25 years. This vaccine only targets two strains of HPV (16 and 18), and therefore reduces the risk of cervical cancer, but not genital warts.
The makers of Gardasil are planning to release a new HPV vaccine, known as V503, which will target nine strains of the virus, instead of only four.
There are more than 100 different types (strains) of HPV, and about 40 of these cause genital infections. Of those 40, about half can cause cancer, and some can cause genital warts. The four types of the virus that Gardasil prevents cause 90 percent of genital warts (types 6 and 11) and 70 percent of cervical cancer (types 16 and 18) . So, even though the vaccine only targets a few strains of the virus, those few strains are responsible for causing most cases of cervical cancer and genital warts.
Some mistakenly believe that the vaccine prevents 70 percent of HPV. This is not true. Others mistakenly believe that the vaccine is only 70 percent effective. This, also, is not true. The vaccine is extremely effective, but only as it relates to preventing those four types of the virus. While the vaccine may prevent two cancer-causing strains of HPV, an article in The New England Journal of Medicine pointed out that blocking these strains of the virus may allow other cancerous HPV strains to fill the void . If this happens, the overall decrease in cervical cancer would be reduced.
According to The Journal of the American Medical Association, 27 percent of women between the ages of 14 and 49 are currently infected with HPV. However, only 3.4 percent are infected with the strains of the virus covered by Gardasil .
According to Merck, the drug maker of Gardasil, clinical trials have demonstrated the vaccine to be both safe and effective. Common side effects of the drug include pain at the injection site, swelling, fever, nausea, diarrhea, vomiting, and dizziness. However, concerned women and parents who Google “lawsuit” and “Gardasil” are often taken aback by how many organizations doubt the drug’s safety and how many lawsuits have been filed against Merck because of the drug.
Since the vaccine is new, the long-term side effects have yet to be determined. Hopefully, serious effects of the drug will be rare, improvements will be made, and it will prove to be an effective help in decreasing rates of cervical cancer worldwide, which takes the lives of about 288,000 women annually .
Mandating the vaccine
Because Gardasil has been approved for use in women aged 9-26, there has been much debate over whether or not states should mandate the vaccine. Many government officials have opposed such a mandate, partly because the drug only went through three and a half years of testing . The director of the National Institutes of Health added, “We don’t know what the long-term effects of Gardasil are because it’s too early, so I would say to walk before you run. . . . You have to understand that in public health, what the doctor says is not always the only thing that counts”.
Another reason why legislators are hesitant to mandate the drug is because HPV is not a contagious disease, like measles, that could be easily transmitted from student to student. Since it is a sexually transmitted disease, its transmission depends upon one’s behavior. In fact, the number one risk factor for genital HPV infection is one’s number of lifetime sexual partners .
While the CDC recommends routine use of the vaccine for adolescent females, Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention’s advisory committee on immunization practices (ACIP) said that lawmakers should not make the vaccination mandatory, and that Merck should not lobby the state governments to require it for school attendance . Likewise, the chair of the American Academy of Pediatrics’ committee on infectious disease does not support making the vaccine mandatory. “I think it’s too early,” he said. “This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine” .
Thankfully, Merck suspended its lobbying efforts, in the midst of a firestorm of criticism from parents and concerned organizations. Debate is sure to continue, especially since HPV vaccines have generated billions of dollars in revenue for pharmaceutical companies.
Should girls (and boys) receive the vaccine? Some fear that widespread promotion of the vaccine will serve as an endorsement for sexual behavior, but research has shown that the vaccine is not related to an increase in promiscuity.
Many parents have decided that because their children are abstinent, there is no need to vaccinate them. Unfortunately, many physicians have treated these parents scornfully as a result of their decision. The choice of each parent must be respected. Parents should not be bullied into giving their children drugs that prevent diseases that already preventable through abstinence.
Many teens have also expressed a desire not to receive the vaccination. Their decision should likewise be respected, since chastity prevents all strains of genital HPV, not just four. If an abstinent teenage girl planned to marry a man who had previously been sexually active, she could always receive the vaccination prior to her marriage. By then, more data will have been gathered as to the safety and efficacy of the vaccine. In the end, the decision needs to be made by the patient, the family, and the physician.
. Kahn, “Vaccination as a Prevention Strategy for Human Papillomavirus-Related Diseases,” Journal of Adolescent Health 37: 6S (2005): S10-6; Munoz, et al., “Chapter 1: HPV in the Etiology of Human Cancer,” Vaccine 24 (S3) S1-S10 (2006).
. G. F. Sawaya and K. Smith-McCune, “HPV Vaccination-More Answers, More Questions,” The New England Journal of Medicine 356:19 (10 May 2007): 1991-1993.
. Dunne, et al., “Prevalence of HPV Infection Among Females in the United States,” The Journal of the American Medical Association 297:8 (February 2007): 813-819.
. World Health Organization, International Agency for Research on Cancer, 2006 (www.iarc.fr).
. “Abstinence Clearinghouse Statement on Mandated HPV Vaccine,” 14 (February 2007).
. Angela Zimm, “GlaxoSmithKline Seeks Approval for Cervical Vaccine,” Bloomburg (29 March 2007).
. Baseman, et al., “The Epidemiology of Human Papillomavirus Infections,” Journal of Clinical Virology 32 S:1 (2005): 16-24.
. Gregory Lopes “CDC Doctor Opposes Law for Vaccine,” The Washington Times (February 27, 2007).
. Nikita Stewart and Rob Stein, “D.C. Bill Would Mandate Vaccine: Proposal for Girls Under 13 Targets Cervical Cancer,” The Washington Post (10 January 2007), A01.
. Bednarczyk RA, Davis R, Ault K, Orenstein W, Omer SB. Sexual activity-related outcomes after human papillomavirus vaccination of 11- to 12-year-olds. Pediatrics. 2012;130:798-805. http://pediatrics.aappublications.org/content/early/2012/10/10/peds.2012-1516.full.pdf+html Accessed April 10, 2013.