Why, after 8 years, are parents still conflicted about giving their children the HPV vaccine?
While all vaccines have risks and benefits, the HPV vaccine is particularly controversial because of the age at which it’s given. “This vaccine has lots of baggage associated with it” because it’s best given before sexual activity starts and no parent wants to think of their preteen as being sexually active, explains Rodney Willoughby, MD, professor of pediatrics at the Medical College of Wisconsin and a consultant at Children’s Hospital in Milwaukee.
He adds that the vaccine could have been given to infants, but because they have to get so many vaccines, it seemed logical to place the HPV vaccine in preteenhood. “In retrospect, it wasn’t a good choice because it became a sex vaccine rather than a cancer vaccine.”
The 3-shot Gardasil series — approved by the FDA for girls in 2006 and for boys in 2009 — has 2 major selling points: First, it protects against certain strains of cervical cancer caused by the human papillomavirus (HPV). Second, it lowers the incidence of genital warts, which is why it is given to both boys and girls. A competing vaccine, Cervarix, approved by the FDA in 2009, prevents against the same cervical cancers as Gardasil but not against genital warts so it is useful for girls but not for boys.
Why is there a need for an HPV vaccine? There are more than 40 types of HPV that can affect the genital areas, mouth and throat of males and females, making HPV the most common sexually transmitted infection in the US today. About 79 million Americans are currently infected with the virus, and roughly 14 million people become newly infected each year, says the CDC. While these statistics may seem alarming, most people with HPV never develop symptoms or health problems (9 of 10 HPV infections go away by themselves within 2 years). But sometimes HPV infections will persist and cause health issues such as genital warts, cervical cancer, oropharyngeal cancer (throat cancer), anal cancer, vulvar and vaginal cancer, and penile cancer.
According to the CDC, about 17,500 women and 9,300 men are affected by cancers caused by HPV each year. Cervical cancer (women) and oropharyngeal cancer (men) are the most common among them. In addition, about 1 in 100 sexually active adults in the US has genital warts at any given time.
In an effort to lower those statistics, the CDC has recommended the Gardasil or Cervarix vaccine for girls ages 9 to 26, and the Gardasil vaccine for boys. But because the HPV vaccine produces higher levels of antibodies that fight HPV infection in preteens than it does in older teens or young adults, the CDC’s Advisory Committee on Immunization Practices recommends that the vaccine be administered to children between 11 and 12 years of age. The American Academy of Pediatrics, the American Academy of Family Physicians and the Society for Adolescent Health and Medicine also recommend the vaccine.
The CDC notes that it’s best for preteens to receive the vaccine before becoming sexually active. Most girls and women who become infected with HPV are first exposed to it within 2 to 5 years of having sex. (Boys are advised to receive the vaccine, not only to protect against genital warts and HPV-related cancers — but also to help stop the spread of HPV to their partners during sex.) Teens and young adults who are sexually active can still receive the vaccine but may derive fewer benefits if they’ve already been exposed to one or more of the HPV types the vaccine targets. Also, because the vaccine does not protect against all types of HPV that cause cervical cancer, girls who are vaccinated still need to get regular Pap tests. Girls can receive the vaccine through the age of 26 and boys through the age of 21.
8 Questions to Ask Your Child’s Pediatrician About the HPV Vaccine
- Do you recommend the vaccine?
- What kind of side effects have you seen immediately after the shot?
- Based on how the vaccine works, do you think there will be long-term adverse effects?
- How long have you been giving this vaccine?
- Do you know of any adverse events among your patients or in this area?
- Would you give this to your child?
- If I get this vaccine for my child, what reactions should I be on the alert for?
- How long will protection from the HPV vaccine last?
According to New York State’s Department of Health, the vaccine is not recommended, however, to women who are pregnant or to anyone who has had a severe allergic reaction to any component of the HPV vaccine. Anyone with a severe allergic reaction to latex or yeast should point this out to their health care provider before receiving the vaccine.
In the short time that the HPV vaccine has been available, a number of mild and more serious side effects have been reported both in the US and elsewhere, and it’s possible there will be more in the future. All of this makes a parent wonder if the vaccine is worth the risk. Here are some pros and cons to help you decide.
The HPV vaccine can protect against precancerous cervical lesions.
In 2014, an estimated 12,360 new cases of invasive cervical cancer will be diagnosed, and roughly 4,020 US women will die from the disease, according to the American Cancer Society. Currently, cervical cancer ranks third in frequency for both diagnosis and cause of death among gynecological cancers, behind endometrial and ovarian cancers.
But early clinical trials conducted on the HPV vaccine suggest it has life-saving potential. Of 10,000 women ages 15 to 25 who were vaccinated as part of clinical trials, none developed high-grade HPV-16 or HPV-18 associated cervical lesions, which are precursors to invasive cancer. The results led experts to estimate that universal uptake of available HPV vaccines likely would prevent more than two-thirds of cervical cancers worldwide (virtually all of those caused by HPV-16 and HPV-18). Now that the HPV vaccine has been on the market for a while, a growing body of research conducted in the US — as well as in Australia, Europe and Canada (where the vaccinations are given through school-based, national programs) — has seen similarly positive outcomes.
Early results look promising.
Studies looking at data from 2007 to 2010 show that in the first 4 years of vaccine availability in the US, there was a 50% overall reduction, among girls ages 14 to 19, in the 4 types of HPV the vaccine protects against. In Australia, where the national HPV program has achieved higher levels of vaccination than in the US, there has been an even greater decline from 2007, the year the vaccine was introduced, to 2011. The prevalence of HPV infections covered by the vaccine fell by more than 75% among women 18 to 24 years of age.
The vaccine can lead to a reduction in genital warts.
A new study published in the journal PLOS One found that the rate of genital warts in young Australian women, ages 15 to 27, decreased by 61%, from 4.33 per 1,000 encounters in a pre-program period (before the National HPV Vaccination Program was established) to 1.67 in a post-program period, lasting from July 2008 to June 2012.
According to the CDC, about 360,000 people — girls and boys — in the United States get genital warts each year. Genital warts are benign noncancerous growths that result from skin-to-skin contact. In other words, any direct contact with an infected area, including oral sex and heavy petting, can result in warts.
The vaccine may prevent against a rising threat: throat cancer.
The CDC estimates that more than 2,370 new cases of HPV-associated oropharyngeal (throat) cancers are diagnosed in women and nearly 9,356 are diagnosed in men each year in the United States. If the current trend continues, HPV will likely cause more oropharyngeal cancers than cervical cancers by the year 2020, according to a 2011 study published in the Journal of Clinical Oncology. Says senior author Maura Gillison, MD, PhD, in an article in Medical News Today, “These increases may reflect increases in sexual behavior, including increases in oral sex.”
Risk factors for oral and oropharyngeal cancers have typically been older age (median age 62 years at diagnosis) and the use of tobacco and excessive alcohol consumption. However, based on the available evidence, HPV infection is now considered a validated risk factor in both men and women, even in the absence of smoking and alcohol consumption. While neither Gardisil or Cervarix is licensed to prevent oropharyngeal cancers, based on what is known about the biology of this disease, it is highly likely that the vaccines will provide protection against oropharyngeal cancers. As Dr. Gillison explains: Between 90% to 95% of HPV-positive oropharyngeal cancers are caused by HPV-16 — the same HPV type that is currently targeted by the vaccines administered to prevent cervical cancer.
The science suggests that the vaccine is safe.
In clinical trials of 30,000 people, potential side effects ranging from fever to death occurred at the same rate whether patients were given a saline solution placebo or Gardasil. Deaths occurred in 0.1% of people in either group. Since the vaccine was approved, it has been given to at least 12 million people, mostly teenage girls. The FDA and the CDC have received reports of 71 deaths of people who got the vaccine and, on examining them, found no patterns in the way the victims died. Each had different pre-existing conditions or different symptoms.
“The performance of the vaccine so far has been striking and measurable,” says Dr. Willoughby. HPV vaccines are approved for use in over 100 countries and more than 100 million doses have been distributed worldwide. Extensive clinical trial and post-marketing safety surveillance data indicate that both Gardasil and Cervarix are well-tolerated and safe.
The vaccine provides long-lasting protection against HPV.
Studies have shown that the HPV vaccine provides good protection for at least 8 years and that the antibody level is much higher after vaccination than after natural infection. This is good news as high antibody levels usually mean longer protection. Experts predict that protection from the HPV vaccine will last for at least 15 years and probably lifelong, so no booster is required. Having only one series of shots may cut down on potential side effects.
For some, potential side effects and the vaccine’s overall safety record are cause for concern.
Despite the HPV vaccine’s endorsement by groups such as the National Cancer Institute and the CDC, many physicians have hesitated to recommend it based on its potential side effects, which range from more mild (pain at the injection site, fever and fainting) to adverse events (autoimmune and neurological disorders, anaphylaxis and death). Vaccine recipients have also reported experiencing chronic pain, chronic fatigue and sudden premature menopause. “Long-term studies have not been done to show the vaccine’s safety,” argues Janet Levatin, MD, a holistic pediatrician at the Tenpenny Integrative Medical Center in Middleburg Heights, Ohio.
To understand the side effects, it’s important to understand how the vaccine works. Unlike other vaccines, the HPV vaccine does not contain any live, killed or weakened virus, but is made from tiny proteins that look like the outside of the real human papillomavirus. When the vaccine is given, the body makes antibodies in response to the protein to clear it from the body. Those with weakened immune systems are more at risk for potential side effects than others. Anyone who has had a life-threatening reaction to yeast and to other components of the HPV vaccine such as aluminum, L-histidine, polysorbate 80 and sodium borate, or to a previous dose of the HPV vaccine, should not get it.
In the US, the Vaccine Adverse Event Reporting System (VAERS), a national, voluntary surveillance system, was set up to monitor reactions to the HPV vaccine. In an August 2009 Journal of the American Medical Association article that covered the first 30 months that the vaccine was administered, VAERS reported receiving more than 12,000 reports (a rate of 53 reports per 100,000 doses distributed), 772 of which reported serious reactions, including 32 reports of death. “There are enough reports of girls dropping dead or coming down with serious paralysis after the vaccine that I believe they shouldn’t receive it,” says Jane Orient, MD, executive director of the Association of American Physicians and Surgeons. Still, the death reports were reviewed and, according to the CDC, there was no common pattern to the deaths that would suggest they were caused by the vaccine.
“The problem with medicine,” counters Dr. Willoughby, “is that if there’s a condition that is prevalent in a particular population around the same time that a vaccine is given, the vaccine is blamed for the illnesses or, in some cases, deaths.” But, he says, it is important to distinguish between an event caused by a vaccine and an event that merely follows the receipt of a vaccine. Plus, he points out, the VAERS results were generally not that different from what is seen in the safety reviews of the meningitis and Tdap (tetanus-diphtheria-acellular pertussis) vaccines recommended for a similar age group, 9 to 26 years old.
Still, it’s hard to ignore the fact that, to date, 200 claims related to the HPV vaccine have been filed with the Department of Health and Human Services’ National Vaccine Injury Compensation Program (VICP), which has paid out nearly $6 million to 49 victims. “The 200 claims filed with VICP are the small tip of a very large iceberg,” says Dr. Levatin, who believes more claims will be filed in years to come. “We did not know until a generation later that the DES [diethylstilbestrol] which was given to pregnant women in the 1940s through 1960s, would cause serious problems such as cancer and infertility in the recipients’ offspring. We may find many problems in the offspring of HPV vaccine recipients as well.”
Japan withdrew its support of the vaccine, and other countries are following suit.
The Health Ministry of Japan withdrew its support of the vaccine in 2013 amid reports of serious side effects in girls. (See HPV Vaccine and the Japanese Question for more details.) The ministries of Spain, France, Israel and India have also expressed concern, based on adverse reactions to the vaccine. “Other countries are much more prudent than the US when it comes to acknowledging vaccine side effects,” says Dr. Levatin. “In the US, financial interests of pharmaceutical companies and conflicts of interest in the CDC and other government bodies do not readily allow for problems, even serious ones, to be acknowledged.”
The verdict is still out as to whether the vaccine is effective at preventing cervical cancer.
Because the cancer takes 10 to 20 years to develop, it’s too early to look at the effect of HPV vaccinations on cancer outcomes. “There are 4 million kids in the age range to get the HPV vaccine,” says Dr. Willoughby. “But the outcome for those who receive the vaccine won’t be apparent for a decade or 2.” Also, many doctors don’t see the need for the vaccine, given the effectiveness of screening tools such as Pap smears.
“Pap smears are very effective for early detection,” say Dr. Orient. In addition, she says, they are less expensive than the vaccine, which costs around $120 and is not always covered by health insurance plans or government agencies such as Medicaid. Supporters of the vaccine counter that it’s less likely a woman will have an abnormal Pap smear after being vaccinated, which could save her the expense of having additional testing, painful biopsies or surgeries that can jeopardize her reproductive future.
The recommended 3-shot series over a 6-month period is difficult for families to follow.
Although safety concerns remain paramount, Dr. Willoughby believes another reason that the HPV vaccine rate is so low in this country is that the vaccine schedule isn’t exactly user-friendly. In 2013, only about 38% of 13- to 17-year-olds had received all 3 doses of the HPV vaccine. “The issue is that more kids start the vaccine than finish it,” he says. Although some doctors recommend 3 shots even when the 6-month timetable isn’t followed, children (and their parents) often drop the ball on the second and third shots.
The World Health Organization has begun giving girls in developing countries who are vaccinated before age 15, 2 shots instead of 3, spread out over a 12-month period rather than 6, and Dr. Willoughby believes it’s only a matter of time until that practice is adopted here too. “The CDC is looking at a 2-dose schedule, and we’ll probably end up there because the data is saying that 2 doses are almost as effective as 3.”
Making the Decision
When weighing whether to give your own child the vaccine, the bottom line is you have to do your homework and discuss both sides of the complicated issue with a doctor you trust. If you decide to have your child vaccinated, write down and keep handy the dates and the specifics of the vaccine, its brand name, the amount given as well as the doctor’s name and address. Also, if your child is 9 or 10, you can always take a wait-and-see approach until more data is available in regard to the vaccine’s safety record.
Michele Shapiro, a New York City-based freelance writer, contributes health and wellness content to print and online publications including Fitness, Fit Pregnancy and Prevention.com.
For More Information
National Cancer Institute (Fact Sheet on HPV Vaccine)
States With High HPV Vaccine Rates Have Less Cancer (Time, November 11, 2014)
Federal Goal Is to Vaccinate 80% of Boys and Girls Against HPV by 2020 (Wall Street Journal, November 10, 2014)
Oral cancer-causing HPV may spread through oral, genital routes (Science Daily, November 12, 2014)