Why, after 13 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 of Wisconsin 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 pre-teenhood. “In retrospect, it wasn’t a good choice because it became a sex vaccine rather than a cancer vaccine.”
The FDA has approved three HPV vaccines — Gardasil, in 2006 for girls and 2009 for boys; Cervarix, in 2009; and Gardasil 9, in 2014. The most effective of the bunch is Gardasil 9, which targets nine types of HPV and most genital warts, and is currently the only HPV vaccine available in the United States.
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 (nine of 10 HPV infections go away by themselves within two 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 19,400 women and 12,100 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 one in 100 sexually active adults in the US have genital warts at any given time.
In an effort to lower those statistics, the CDC has recommended the Gardasil 9 vaccine for girls and boys ages 9 to 26. 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 two to five 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. Females and males can receive the vaccine through the age of 45, though it’s not routinely recommended after the age of 26.
- 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?
However, according to the CDC, the vaccine is not recommended 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.
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
Of the 34,800 cancer cases caused by HPV every year, 92%, or around 32,000 of those can be prevented by the HPV vaccine, according to the CDC. It does this by giving the body antibodies to prevent being infected. This prevents warts and cancers caused by HPV. There are pap smears for women to detect cervical cancer, and a test to check for HPV in cervical cells before it develops into something more dangerous. But there is no test for men to screen for these cancers or HPV, and there is no medical treatment for HPV itself. There are prescription medications that can eliminate warts, though warts may return after treatment is completed. Otherwise, treatment involves cutting away cells and tissue in the cervix or vagina to remove warts and possible precancerous cells through a procedure such as LEEP (loop electrosurgical excision procedure). However, this may not always remove the whole problem area. The vaccine has decreased rates of infection with HPV types 16 and 18, which cause most cervical cancers, by 83% among girls aged 15 to 19, and by 66% among women 20 to 24.
Early clinical trials conducted on the HPV vaccine suggest it has life-saving potential. Of 17,000 women ages 15 to 26 who had never been infected with HPV and were vaccinated as part of clinical trials, none developed HPV-16 or HPV-18 associated cervical lesions. 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 2006to 2016 show that in the first 10 years of vaccine availability in the US, there was an 86% overall reduction, among girls ages 14 to 19, in the four types of HPV the vaccine protects against. Australia’s national HPV program has led to a significant decline in these infections from 2007, the year the vaccine was introduced. Over the first six years of vaccine use, the prevalence of HPV infection fell by 86%among women 18 to 24 years of age. In Japan, where the government subsidized the HPV vaccine program before suspending the recommendation for its use in 2013, the rate of infection with HPV types 16 and 18 was cut by 84.2% in women aged 18 to 24, between the prevaccine era period of 2008 to 2012 and the vaccine era of 2013 to 2017.
The vaccine can lead to a reduction in genital warts
A 2019 review of studies from 14 countries, published in The Lancet found that the rate of genital warts in women decreased by 67% in those aged 15 to 19, by 54% among women aged 20 to 24, and by 31% in women aged 25 to 29. The data were derived over a five or eight year period after the implementation of vaccines.
According to the CDC, about 360,000 men and women in the United States are treated for 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 about 3,500 new cases of HPV-associated oropharyngeal (throat) cancers are diagnosed in women and about 15,500 are diagnosed in men each year in the United States. According to the National Cancer Institute, oropharyngeal cancers have been increasing each year and are now the most common HPV-related cancer in the US.
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 current vaccines are not licensed to prevent oropharyngeal cancers, in a 2019 study of over 1,200 girls aged 13 to 21, the prevalence of oral HPV was 83% lower in those who had received the HPV vaccination compared to those who had not. And in a study of over 2,600 men and women aged 18 to 33 published in the Journal of Clinical Oncology, vaccination reduced the prevalence of oral HPV by 88%. As study author Maura Gillison, MD, PhD, 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 more than 74,000 people, potential side effects ranging from fever to death occurred at the same rate whether patients were given a placebo or the vaccine. Deaths occurred in less than 0.1% of people in either group, but research has yet to link deaths post-vaccine to the vaccine itself.
“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 200 million doses have been distributed worldwide. Extensive clinical trial and post-marketing safety surveillance data indicate that Gardasil, Gardasil 9 and Cervarix are well-tolerated and safe.
The vaccine provides long-lasting protection against HPV
According to the CDC, the HPV vaccine provides good protection for at least ten years. Additionally, research shows 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 (Centers for Disease Control), 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 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.
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.
A number of young girls, including two sisters, who received the HPV vaccination, Gardasil, found themselves in premature menopause. Some were tested for rare genetic diseases that could cause this but the tests are negative. However, a 2018 study in the journal Pediatrics found no connection between premature menopause and the HPV vaccine. Researchers reviewed the health records of 200,000 women aged 11 to 34 and zeroed in on 59,000 who had received the vaccine. In women who experienced primary ovarian insufficiency between 2006 and 2014, the researchers found no elevated risk of premature menopause after the HPV vaccine.
In 2015, the European Medicines Agency (EMA) completed a scientific review of the evidence surrounding reports of two syndromes — complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) — and the review concluded that the evidence does not support a causal link between the vaccines and development of CRPS or POTS.
A newer study, published in 2018 in the British Journal of Clinical Pharmacology, reported similar results based on VAERS data from 2009 to 2017. Over that time, around 720,000 doses of the vaccine were distributed. The FDA received only 241 adverse event reports and 95.8% were classified as not serious.
“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 meningitis and Tdap (tetanus-diphtheria-acellular pertussis) vaccines recommended for a similar age group.
Still, it’s hard to ignore the fact that, as of July 1, 2019, 415claims, including 15 deaths, related to the HPV vaccine have been filed with the Department of Health and Human Services’ National Vaccine Injury Compensation Program (VICP), which has compensated 130 victims. “The 415 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.” ed note: DES’s ability to cause mammary gland tumors in mice was known seven years before the FDA approved DES as a miscarriage preventative and within six years of approval was shown to be ineffective in a major published study. These studies were ignored until 1971 when a rare vaginal cancer was reported in a group of young girls, who had been exposed prenatally to DES. The FDA did not ban DES but changed its label to be contraindicated in pregnant women. For more see www.DESAction.org, MedShadow’s sister organization. Our research could not find ignored studies on HPV, but not all studies are published.
Many concerns surrounding the HPV vaccine are about sexual activity. Parents may be nervous giving their pre-teen a vaccination to prevent dangers from a sexually-transmitted disease for fear it could be seen as promoting risky sexual behavior. The National Institute for Public Health and the Environment in the Netherlands conducted a study, published in 2018, measuring the effect of the vaccine on the risky sexual behavior in teenage girls. A random sample of 19,939 girls, ages 16 to 17, were given questionnaires every six months for two years after their vaccines. There was no significant evidence indicating a difference between the sexual behavior of those vaccinated compared to those who were not.
Japan withdrew its support of the vaccine, and other countries are following suit
The Ministry of Health, Labour and Welfare of Japan withdrew its support of the vaccine in 2013 amid reports of serious side effects in girls. Although a review of complaints led experts to determine that symptoms were not related to the vaccine, the Ministry has not resumed the vaccine program. (See HPV Vaccine and the Japanese Question for more details.) The vaccine has become controversial in other countries, including France, Denmark and India, also based on reports of 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 four 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 two.” 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,” says Dr. Orient. In addition, she says, they are less expensive than the vaccine, which costs around $190 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.
A Cochrane review published in May 2018, however, indicates the vaccine is beneficial. The meta-analysis evaluated the effectiveness of the HPV vaccine in preventing precancers. Twenty-six studies were examined involving 73,428 women and adolescent girls over a period of 0.5 to 7 years. Participants in the study were free of HPV prior to the trial and were evaluated based on protection against precancers due to HPV vaccination. Researchers compared the HPV vaccination to a placebo vaccine. Results showed that the HPV vaccination reduced the likelihood of developing cervical precancers significantly compared to the dummy vaccine. The research also showed that the vaccine is more effective among younger women. There were no serious side effects associated with the vaccine throughout the trial. The vaccine did not increase the rate of miscarriages or stillbirths.
The recommended 3-shot series over a 6 or 12 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 for some age groups. The CDC now recommends two doses of the vaccine (an improvement over the previous three-dose recommendation), six to twelve months apart, for children who get their first dose before their fifteenth birthday. The three-dose schedule over a six-month period is still recommended for those aged 15 to 26. In 2017, only about half of 13- to 17-year-olds had received all the recommended doses of the HPV vaccine. “The issue is that more kids start the vaccine than finish it,” he says. Although some doctors recommend the full series of shots even when the timetable isn’t followed, children (and their parents) often drop the ball on the second and third shots.
Now researchers are looking at the potential for a one-dose vaccine. In a 2019 study published in Papilloma Research, a review of the health records of more than 250,000 women found that one dose had the same effectiveness as two or three doses in preventing cervical precancer.
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)
HPV Immunization Program Cuts Pre-Cancer Rates By More Than Half (Science Daily, October 21, 2019)
The HPV Vaccine: Access and Use in the U.S. (KFF: Women’s Health Policy, October 9, 2018)
More Than 70% of US Adults Are Not Aware of HPV Cancer Risks (Helio, September 27, 2019, based on JAMA Pediatrics report)
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)