HPV Vaccine

The Centers for Disease Control and Prevention (CDC) recommends all children who are 11 or 12 years old get vaccinated for the Human Papillomavirus (HPV). Rhode Island, Virginia and Washington, D.C. mandate the HPV vaccine for school, and as of March 2017, at least eight states had proposed HPV-related laws for the 2017-18 legislative sessions.

*Please seek the advice of a medical professional before discontinuing the use of this vaccine.

Gardasil Vaccine Box

Used to Prevent: Vulvar and vaginal cancer; cervical cancer; genital warts; anal cancer; precancerous or dysplastic lesions; throat cancer; penile cancer

Ingredients: Proteins of HPV Types, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate and water

Manufacturer: Merck & Co. Inc.; GlaxoSmithKline Biologicals

FDA Approval: Gardasil 9-2014; Cervarix-2009 (expired November 2016); Gardasil-2006 (expired May 2017)

HPV is the most common sexually transmitted infection in the world. Nearly all men and women will get at least one type of HPV at some point in their lives, according to the CDC. About 80 million Americans are currently infected with some type of HPV, and some 14 million people in the U.S. become newly infected every year.

HPV is spread through intimate sexual contact such as vaginal, anal or oral sex. Sometimes, a pregnant woman with HPV can pass it to her baby during delivery, though it’s not very common. There are no documented reports of HPV spreading through contact with a toilet seat or other surfaces in the environment, but a person could be exposed to the infection from an item shared during sexual activity if the item has been used by someone infected with HPV.

The medical community has identified more than 150 HPV types. Nine out of 10 infections go away by themselves within two years and do not cause health problems, according to the CDC. However, when HPV does not go away, it can cause warts and certain cancers. In fact, HPV causes 30,700 cancers in Americans every year.

microscopic 3d view of HPV virus
3D view of the HPV Virus

To protect against certain types of HPV, the U.S. Food and Drug Administration (FDA) approved three vaccines — Gardasil, Cervarix and Gardasil 9 — beginning in 2006. All doses of Gardasil and Cervarix have since expired, making Gardasil 9 the only HPV vaccine currently available in the U.S. According to the CDC, the HPV vaccine can prevent about 28,000 cancers from occurring every year. It does not prevent all types of cervical cancer, so it is important for women to continue routine cervical cancer screenings. The HPV vaccine is not a cure, and it does not treat cancer or genital warts.

The vaccine prevents infection with HPV types that are associated with:

  • cervical cancer in females
  • vaginal and vulvar cancers in females
  • anal cancer in females and males
  • throat cancer in females and males
  • penile cancer in males
  • genital warts

The HPV vaccine may not fully protect everyone, and it cannot protect people from a disease that is caused by other types of HPV, other viruses or bacteria. The vaccine is made from protein from the virus, but it is not possible to get HPV or any disease caused by HPV from the vaccine.

Who Gets HPV Vaccine and How is it Given?

The FDA approved the HPV vaccine for both males and females, and it may be given beginning at age 9 years through age 26 years. The CDC recommends the vaccine for all boys and girls ages 11 or 12 years because response to the vaccine is better at this age than at older ages. The agency says the HPV vaccine is most effective if given prior to HPV exposure and teenagers who did not start or finish the HPV vaccine series when they were younger should get it right away.

“There is no reason to wait to vaccinate until teens reach puberty or start having sex,” according to the CDC website. “Preteens should receive all recommended doses of the HPV vaccine series long before they begin any type of sexual activity.”

“There is no reason to wait to vaccinate until teens reach puberty or start having sex. Preteens should receive all recommended doses of the HPV vaccine series long before they begin any type of sexual activity.”

– Centers for Disease Control and Prevention

The CDC also recommends the HPV vaccine for certain people through age 26 if they did not get vaccinated when they were younger. These include young men who have or intend to have sex with men; young adults who are transgender; and young adults with certain immunocompromising conditions, including HIV. The HPV vaccine is recommended based on a person’s age, not his or her sexual experience. The CDC says even if a person in the recommended age group has already had sex, he or she should still get the HPV vaccine.

You Should Not Get the HPV Vaccination If You Are Allergic To:

  • Yeast
  • Amorphous aluminum hydroxyphosphate sulfate
  • Polysorbate 80
  • Reaction to a previous dose of the HPV vaccine

You should not get the HPV vaccine if you are allergic to yeast, amorphous aluminum hydroxyphosphate sulfate or polysorbate 80 (ingredients found in the vaccine), or if you have had an allergic reaction to a previous dose of the HPV vaccine. The HPV vaccine is not recommended for pregnant women, though women who are breastfeeding may be vaccinated, according to the CDC.

The HPV vaccine is usually a shot given in the arm muscle. For about a decade, the CDC recommended doctors administer the HPV vaccine in a three-dose series given over six months. In 2016, however, the agency changed the recommendation to include two dosing schedules based on a person’s age.

“Studies have shown that two doses of HPV vaccine given at least six months apart to adolescents at age 9–14 years worked as well or better than three doses given to older adolescents and young adults,” according to the CDC website. “Studies have not been done to show this for adolescents starting the series at age 15 years or older.”

CDC-Recommended HPV Vaccine Dosing Schedule

Ages 9 to 14 years

Two Dosing Schedule:

First shot: On a date of the patient’s and doctor’s choosing

Second shot: Six to 12 months after first shot

Ages 9 to 14 years

Three Dosing Schedule:

First shot: On a date of the patient’s and doctor’s choosing

Second shot: Two months after first shot

Third shot: Six months after first shot

Ages 15 to 26 years

Three Dosing Schedule:

First shot: On a date of the patient’s and doctor’s choosing

Second shot: Two months after first shot

Third shot: Six months after first shot

Common HPV Vaccine Side Effects

Some patients may faint after getting the HPV vaccine, which can lead to injuries and may cause them to shake or become stiff. To prevent falls, doctors may ask patients to sit or lie down for 15 minutes after they get vaccinated. On very rare occasions, severe (anaphylactic) allergic reactions may occur after vaccination, according to the CDC.

Common side effects of HPV vaccine include:

  • Pain, redness, swelling, itching, bruising, bleeding or a lump where the shot was given
  • Headache
  • Fever
  • Nausea
  • Dizziness
  • Muscle or joint pain
  • Feeling tired

Types of HPV Vaccines

The FDA approved the first of three HPV vaccines in 2006. Gardasil 9 is the only HPV vaccine still available in the U.S.

Gardasil 9

The FDA approved Gardasil 9 in 2014 for use in girls ages 9 to 26 and boys ages 9 to 15. In December 2015, the FDA extended its approval to allow males through age 26 to get the vaccine. Manufactured by Merck & Co. Inc., Gardasil 9 protects against conditions caused by nine HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58. These types can cause cervical, vulvar, vaginal and anal cancers; precancerous or dysplastic lesions; and genital warts.

Gardasil

Gardasil was Merck’s predecessor to Gardasil 9 and the first HPV vaccine approved for use in the U.S. The vaccine gained FDA approval on June 8, 2006. Gardasil was designed only to protect against diseases caused by HPV Types 6, 11, 16 and 18. All lots of Gardasil already distributed in the U.S. expired as of May 2017, according to the CDC.

Cervarix

The FDA approved GlaxoSmithKline’s HPV vaccine, Cervarix, in 2009. Cervarix was designed to protect women and girls against HPV-16 and HPV-18, common high-risk HPV types. In August 2016, GlaxoSmithKline announced it decided to stop supplying Cervarix in the U.S. “due to very low market demand.” The company said it would ship the last Cervarix orders on August 31, 2016. The last doses of Cervarix expired in November 2016, according to the CDC.

Gardasil Vial with Packaging in the Background
Typical packaging of Gardasil Vaccine

HPV Vaccine Clinical Studies

All three HPV vaccines went through years of extensive safety testing before the FDA approved them for use in the U.S. Cervarix clinical trials included more than 30,000 females. Gardasil was studied in trials of more than 29,000 females and males, and Gardasil 9 was studied in trials of more than 15,000 females and males. The subjects of these short-term studies appeared to suffer little harm from the drug.

Side Effects Reported in Clinical Trials:

  • Eight in 10 people experienced some pain at the site of injection
  • One in four people saw redness at the site of injection
  • About one in three people suffered a mild, temporary headache
  • One in 10 people experienced a low fever (100°F), and one in 65 people got a high fever (102°F)

Out of the seven Gardasil 9 studies, four patients reported serious adverse events that were directly related to the vaccine, including a fever, an allergic reaction, an asthmatic crisis and a headache. Agencies continue to monitor the HPV vaccine to make sure it remains safe and effective. The Vaccine Adverse Event Reporting System (VAERS) — which is co-managed by the FDA and the CDC — allows doctors to report when a patient experiences unusual symptoms after getting any vaccine.

Adverse Events and HPV Vaccine

Dr. Diane Harper, who worked on studies that got the HPV vaccines approved, has said Gardasil is associated with serious adverse events, including death.

“Parents and women must know that deaths occurred,” Harper told CBS News. “Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year.”

Gardasil Adverse Events

Documents from VAERS detail 26 deaths from HPV vaccination between September 1, 2010, and September 15, 2011.

Documents from VAERS detail 26 deaths between September 1, 2010, and September 15, 2011, Dr. Peter Lind, who practices metabolic and neurologic chiropractic, said in a Washington Times report. “That’s 26 reported deaths of young, previously healthy, girls after Gardasil vaccination in just one year,” he said.

Harper told the Huffington Post that Gardasil was proven to have caused at least one verified case of auto-immune initiated motor neuron disease. Neurologists presented the finding at the 2009 American Neurological Association meeting in Baltimore, Maryland. A recent study in the Journal of the American Medical Association found Gardasil has a higher incidence of blood clots reported. The HPV vaccine has also been linked to other serious adverse events, including incidents of seizures, paralysis, blindness, pancreatitis, speech problems and short term memory loss, Lind said.

VAERS Reports

From June 2006 through March 2014, about 67 million doses of Gardasil were distributed in the U.S. VAERS received a total of 25,063 adverse event reports in 22,867 females and 2,196 males after HPV vaccination. Of the total Gardasil reports, 7.6 percent were classified as serious, meaning they resulted in permanent disability, hospitalization, life-threatening illnesses or death. In these cases, headache, nausea, vomiting and fever were the most frequently reported symptoms for both males and females. In 2009 alone, 12.8 percent of reports to VAERS were classified as serious. In 2013 (the last full year of reporting), 7.4 percent were classified as serious.

Among the 92.4 percent that were classified as nonserious fainting, dizziness, nausea, headache and fever were the most commonly reported in females. Dizziness, fainting, pallor, headache and loss of consciousness were the most commonly reported symptoms in males. Overall, the most commonly reported local symptoms were injection-site pain and redness.

Reported Adverse Events:

Guillain-Barré Syndrome

The adverse event reports also describe incidents of Guillain-Barré syndrome, a nervous system disorder, Lind said. In patients with Guillain-Barré syndrome, the body’s immune system attacks its own nerves, causing weakness and instability, difficulty breathing, changes in blood pressure, and other troublesome symptoms. Between Jan. 1, 2010 and Dec. 31, 2012, VAERS documented nine reports of Guillain-Barré syndrome following Gardasil vaccination. Studies provide conflicting evidence about whether this syndrome occurs more frequently following Gardasil vaccination.

Premature Ovarian Failure (POF)

In January 2016, the American College of Pediatricians published a press release that addressed a possible link between Gardasil and ovarian function. In particular, the group discussed the risk of premature ovarian failure (POF), also known as premature menopause. The College stated that there is no strong evidence to suggest a link between Gardasil and POF, but that they released the information so that Americans could make the most informed decisions as possible. It also stated that Cervarix had been used by patients in 8.5 percent of VAERS reports for amenorrhea from February 2010 to May 2015. Amenorrhea is the absence of menstruation. Without menstrual periods, a woman cannot become pregnant.

Postural Orthostatic Tachycardia Syndrome (POTS)

The autoimmune disease POTS may be triggered by HPV vaccines. POTS — which is present in 170 in 100,000 persons — is marked by an abnormally rapid heart rate increase that occurs when a person assumes an upright position. One study showed that POTS manifested three to five times more frequently in HPV vaccine recipients than in recipients of another vaccine that is commonly given to American youth, Varivax (which protects from Varicella virus). Additionally, medical professionals have provided anecdotal evidence of this link after witnessing patients acquiring POTS following HPV vaccination

A study published Clinical Rheumatology in 2015 found evidence of complex regional pain syndrome, postural orthostatic tachycardia and fibromyalgia after HPV vaccination.  Authors of the questionnaire-based study used validated questionnaires to evaluate the chronic illness that might appear after HPV vaccination. The questionnaires were the 2010 American College of Rheumatology Fibromyalgia Diagnostic Criteria, COMPASS 31 dysautonomia questionnaire and S-LANSS neuropathic pain form. They emailed the questionnaires and a “present illness” survey to people who had the onset of a chronic ailment soon after HPV vaccination, and in one months’ time collected 45 filled questionnaires from residents of 13 different countries. They concluded that “a disabling syndrome of chronic neuropathic pain, fatigue and autonomic dysfunction may appear after HPV vaccination.”

ASL

Gardasil’s maker Merck has said it was looking into cases of ALS, commonly known as Lou Gehrig’s disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC have said there is no evidence that Gardasil caused ALS in the cases reported.

HPV Vaccine Claims

Hundreds of people who say they were injured by an HPV vaccine have filed claims with the National Vaccine Injury Compensation Program (VICP), a government system that may provide financial compensation to people who file vaccine-related injury or death petitions. The VICP paid more than $5.8 million to 49 Americans after the U.S. Court of Federal Claims found the individuals had been injured by Gardasil.

The VICP paid more than $5.8 million to 49 Americans after the U.S. Court of Federal Claims found the individuals had been injured by Gardasil.

HPV vaccine lawsuits are not limited to the U.S. On July 27, 2016, in Japan, 63 plaintiffs filed a class action lawsuit against the Japanese government and drug makers Merck and GlaxoSmithKline. The suit cited multiple physical problems, including headaches, extreme tiredness and trouble moving, after the plaintiffs had been given HPV vaccines. Attorneys were seeking compensation of more than $140,000 per plaintiff. The Japanese government promoted HPV vaccines in 2009, but redacted its recommendation in 2013 following anecdotal reports of adverse effects.

HPV Vaccine Controversy

Because of the potential dangers of HPV, several states have chosen to mandate HPV vaccination in pre-teens and teens. Rhode Island, Virginia and the District of Columbia have made the HPV vaccine mandatory for schoolchildren. Students may opt out with a doctor’s note.

A growing number of parents, members of the medical community and researchers oppose HPV vaccine mandates and are calling for an independent study of the HPV vaccine.

“It seemed very odd to be mandating something for which 95 percent of infections never amount to anything.”

– Dr. Diane Harper, to NPR

“Some 52 countries included the HPV vaccine in their national vaccination programs. Since 2014, more than half have dropped out. There was a huge array of debilitating medical conditions,” said Deborah H. Jennings, a retired nurse and member of Rhode Islanders Against Mandated HPV Vaccinations. “I don’t think it should be on the market. It’s the most dangerous vaccine.”

Dr. Harper has also voiced objections to HPV vaccine mandates.

“Ninety-five percent of women who are infected with HPV never, ever get cervical cancer,” she told NPR. “It seemed very odd to be mandating something for which 95 percent of infections never amount to anything.”

She told NPR that Pap screening is the biggest thing a woman can do to protect herself and to prevent cervical cancer. Harper also noted that studies so far show the vaccine protects for four or five years and that it is possible girls who get the vaccine may need a booster shot when they’re older.

“If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit.”

– Dr. Diane Harper, to CBS News

Harper has said her most important point is that the use of this vaccine must be done with informed consent and complete disclosure of the benefits and harms of HPV vaccines and Pap screening.

“The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value,” Harper told the Huffington Post.

HPV vaccines have made their way into American politics as well. In 2011, Republican politician Michele Bachmann claimed that HPV vaccines could cause intellectual disabilities. (The CDC has not reported a link between the HPV vaccine and the development of intellectual disabilities.)

Author

emiller@drugwatch.com
407-955-4198

Emily Miller holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science and the Society for Technical Communication. Emily was diagnosed with a chronic illness as a child and has firsthand experience with many of the topics she writes about as a member of the Drugwatch team. She is an award-winning journalist who has reported on health and legal news for reputable organizations, including the South Florida Sun Sentinel, San Antonio Express-News, UF Health News and Reporters Committee for Freedom of the Press. She draws on her background as both a patient and a journalist to help readers understand complex health and legal topics.


Hide Sources

  1. FDA.gov. (n.d.). USPPI Patient Information about Gardasil. Retrieved from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111266.pdf
  2. CDC.gov. (2013, May 17). HPV (Human Papillomavirus) Gardasil VIS. Retrieved from https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil.html
  3. American College of Pediatricians. (2016, January). New Concerns about the Human Papillomavirus Vaccine. Retrieved from https://www.acpeds.org/the-college-speaks/position-statements/health-issues/new-concerns-about-the-human-papillomavirus-vaccine
  4. CDC.gov. (2014, August 29). Human Papillomavirus Vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6305a1.htm
  5. National Conference of State Legislatures. (2017, April 11). HPV Vaccine: State Legislation and Statutes. Retrieved from http://www.ncsl.org/research/health/hpv-vaccine-state-legislation-and-statutes.aspx
  6. CBS News. (2016, October 20). CDC: Preteens only need 2 doses of HPV vaccine, not 3. Retrieved from http://www.cbsnews.com/news/preteens-only-need-2-doses-of-hpv-not-3/
  7. GlaxoSmithKline. (2016, August 18). Important Information. Retrieved from https://www.gskdirect.com/medias/GSKDirect-Cervarix-Tip-Lok-Syringe-Discontinuation-8.18.2016.pdf?context=bWFzdGVyfHJvb3R8OTg1NDB8YXBwbGljYXRpb24vcGRmfGhmMi9oYTUvODg0MTAyNTM4ODU3NC5wZGZ8NmE4NzUzYWUwMzYwMTE0Mjg2NmRhMmMwODQwOTY1YTA1ZDQ3YjliMGZlODY2ZmYwOGE5ZmU3YmEyODQxOTFjOA
  8. CDC.gov. (2016, November 21). Questions and Answers. Retrieved from https://www.cdc.gov/hpv/parents/questions-answers.html
  9. Gardasil9.com. (n.d.). How Is Gardasil 9 Given? Retrieved from https://www.gardasil9.com/about-gardasil9/schedule/
  10. Martinez-Lavin, M. et al. (2015, November). HPV vaccination syndrome. A questionnaire-based study. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26354426
  11. NPR.org. (2011, September 19). HPV Vaccine: The Science Behind The Controversy. Retrieved from http://www.npr.org/2011/09/19/140543977/hpv-vaccine-the-science-behind-the-controversy
  12. Yerman, M. G. (2010, March 18). An Interview with Dr. Diane M. Harper, HPV Expert. Retrieved from http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html
  13. Attkisson, S. (2009, August 19). Gardasil Researcher Speaks Out. Retrieved from http://www.cbsnews.com/news/gardasil-researcher-speaks-out/
  14. Lind, P. (2014, December 31). U.S. court pays $6 million to Gardasil victims. Retrieved from http://www.washingtontimes.com/news/2014/dec/31/us-court-pays-6-million-gardasil-victims/
  15. Ojha, R.P. (2014). Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/24013368
  16. Creative Commons. (n.d.). Gardasil. [[File:HPV-vaccine- Gardasil2016JAPAN-03.jpg|HPV-vaccine- Gardasil2016JAPAN-03]]
  17. Creative Commons. (n.d.). Gardasil [[File:Gardasil vaccine and box.jpg|Gardasil vaccine and box]]
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