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HPV Vaccines

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There are several vaccines to help prevent the spread of HPV, human papillomavirus. Though the American government recommends that eligible citizens receive the vaccination, there are ongoing disputes over the safety of HPV vaccines.

HPV Vaccination in the U.S.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the world. Since it can cause side effects like warts and even some cancers, doctors have developed a vaccine to prevent young people from acquiring this virus. The first HPV vaccine was approved by the U.S. Food and Drug Administration (FDA) in 2006. Since then, the safety of these drugs has been questioned by parents, doctors, politicians and researchers.

Who Gets Vaccinated and How is it Done?

Vaccination is given through a series of three injections. Following the first shot, patients must receive a second in 1 to 2 months. Finally, the third shot follows six months later. All Marketplace health insurance plans cover in-network HPV vaccinations. Without insurance, the shots cost around $390 to $450. Uninsured youth up to and including age 18 may have their immunization costs covered by the government program Vaccines for Children. The Advisory Committee on Immunization Practices (ACIP) recommends that females ages 11 to 26 and males ages 13 to 21 should be vaccinated against HPV. (Males can be vaccinated up to age 26 as well, but ACIP says it is more beneficial for males to receive the vaccine by age 21.) After age 26 in both sexes, the benefits of HPV vaccination are slim to none. Despite ACIP’s recommendations, only 40 percent of teen girls and 58 percent of teen boys have received at least one of the three shots. Although people who already have HPV may receive the vaccine, they will not obtain its maximum benefits. The vaccine is not a cure, but intended to prevent future infections. The following populations are at an especially high risk of acquiring HPV, so their doctors may more strongly recommend the HPV vaccine:
  • Anyone who is sexually active
  • Men who have sex with men
  • Anyone who has multiple partners
  • People who have HIV or are otherwise immunocompromised

FDA-Approved HPV Vaccines

By the time the FDA approved the first HPV vaccine, the drug had already been tested on thousands of people around the world. The subjects of these short-term studies appeared to suffer little harm from the drug. Because long-term studies have not been done, protections are in place to monitor the long-term safety of these drugs. For example, 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. There are currently three HPV vaccines that are approved by the FDA: Gardasil, Gardasil 9 and Cervarix. Each of these drugs prevents both HPV-16 and HPV-18 infections, two high-risk types of HPV which cause about 70% of cervical cancers.

Gardasil

Gardasil is manufactured by Merck, and was approved by the FDA on June 8, 2006. In addition to HPV-16 and HPV-18, Gardasil also protects against HPV-6 and HPV-11, which cause genital warts. Gardasil was tested on 29,000 human subjects before the FDA approved it for use in the U.S. Prior to Gardasil’s approval, no long-term ovarian function studies were conducted on humans or mice. Since Gardasil emerged on the market, there have been 213 VAERS reports of amenorrhea, POF or premature menopause. In 88% of these cases, the patient had previously been vaccinated with Gardasil. 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 to that Americans could make the most informed decisions as possible. Further studies are currently underway, but results may take years.

Gardasil 9

Gardasil 9 is manufactured by Merck, and was approved by the FDA on December 10, 2014 for girls ages 9–26 and boys ages 9–15. On December 14, 2015, the FDA extended its approval to allow males through age 26 to get the vaccine. In addition to HPV-16 and HPV-18, Gardasil 9 protects against HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58, which together cause 90% of cervical cancers. Gardasil 9 was tested on 15,705 human subjects before the FDA approved it for use in the U.S. Out of the seven 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.

Cervarix

Cervarix is manufactured by GlaxoSmithKline, and was approved by the FDA on October 16, 2009. Cervarix protects women and girls against HPV-16 and HPV-18. Cervarix was tested on 30,000 human female subjects before the FDA approved it for use in the U.S. A January 2016 press release by the American College of Pediatricians raised concern about this drug. It stated that Cervarix had been used by patients in 8.5% of VAERS reports for amenorrhea from February 2010–May 2015. At present, researchers are following up with Costa Rican women who participated in a study on the long-term safety of Cervarix. Results are pending.

Side Effects of HPV Vaccine

HPV vaccination carries some mild to moderate side effects. At this time, HPV vaccination is not considered to cause any serious side effects.

Guillain-Barré Syndrome

The nervous system disorder Guillain-Barré syndrome has been noted in people who have had HPV vaccines. In patients with this disorder, the body’s immune system attacks its own nerves, causing weakness and instability, difficulty breathing, changes in blood pressure, and other troublesome symptoms. Although vaccinated people suffer from Guillain-Barré syndrome at the same rate as the general population, which is about 1–2 persons in 100,000, researchers may have determined a link between HPV vaccines and Guillain-Barré syndrome.

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 large 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 acquire POTS following HPV vaccination.

Side Effects Reported in Clinical Trials

The following side effects may occur during and after HPV vaccination:
  • Eight in 10 people experience some pain at the site of injection.
  • One in four people sees redness at the site of injection.
  • About one in three people suffers a mild, temporary headache.
  • One in 10 people experiences a low fever (100°F), and one in 65 persons gets a high fever (102°F).
  • Some fainting was reported.

Human Papillomavirus (HPV)

Human papillomavirus (HPV) is a very common sexually transmitted infection (STI) that is spread through intimate skin-to-skin contact, such as vaginal, anal or oral sex. It can also be spread from mother to infant during birth. Though condoms and dental dams reduce the risk of spreading HPV, more than half of all sexually active persons will get this virus at some point. The Centers for Disease Control and Prevention (CDC) says 80 million Americans are infected with HPV and 14 million new infections occur each year. Most of the 100-plus forms of HPV are low-risk and have no impact or symptoms, but others may cause warts on various areas of the body, such as the hands, feet or genitals. There are several high-risk forms of HPV that can cause some cancers.

HPV Treatment and Testing

There is no HPV test for men. Since the virus is so common, most doctors do not routinely screen women for it. High-risk HPV is usually detected when a woman receives abnormal Pap test results. Because HPV can lie dormant in the body for years, it is often impossible to pinpoint the source or date of infection. Most of the time, HPV goes away on its own within 8 to13 months, but that is not always the case. Some strains of HPV remain in the body for life.

Cancers Caused by HPV

High-risk HPV types can cause cancers of the penis, vagina, vulva, anus, throat and — most frequently — cervix. Cervical cancer is the second leading cause of cancer death in all women. In the U.S. alone, 10,000 women are diagnosed with cervical cancer each year. Though the disease is usually treatable if it is found and treated early, cervical cancer kills 3,700 American women every year.

HPV Vaccine Controversy

Because of the potential dangers of HPV, several states have chosen to mandate HPV vaccination in pre-teens and teens. As of fall 2016, only 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. Some people have fought back against these mandates through activism and lawsuits, saying that HPV vaccination should be a personal choice. The controversy began in 2006, when the Advisory Committee on Immunization Practices (ACIP) first recommended that young people get the HPV vaccine. Associate Professor of Surgery Dr. Mark Donald White covered the issue in his 2014 study Pros, cons, and ethics of HPV vaccine in teens—Why such controversy? He wrote, “There still seems to be controversy surrounding these universal vaccination programs as well as some ethical and practical concerns regarding the administration of a vaccine for diseases that are associated with sexual contact in both sexes, especially during the early adolescent years.” 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.)

Lawsuits

Since the government’s Vaccine Injury Compensation Program (VICP) was established in 1982, it has paid out over $3 billion to patients who have been harmed by their vaccines. Some of that money has gone to patients who claimed they were harmed by HPV vaccines. More HPV vaccine lawsuits will follow as further research emerges, and if evidence strongly links these drugs to adverse effects.

Gardasil Lawsuits in the U.S.

Though hundreds of Americans have sued over Gardasil, only about half of these lawsuits are ever heard by a judge. However, some suits have been successful. In 2013, VICP reported that it had awarded $5,877,710 to 49 plaintiffs, after finding that those Americans had been injured by Gardasil.

Gardasil Lawsuits Abroad

Gardasil 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 are seeking compensation of over $140,000 per plaintiff. The outcome of this lawsuit is pending. The Japanese government promoted HPV vaccines in 2009, but in 2013 redacted its recommendation following anecdotal reports of adverse effects.