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 VaccinesBy 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.
GardasilGardasil 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 9Gardasil 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.
CervarixCervarix 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 VaccineHPV vaccination carries some mild to moderate side effects. At this time, HPV vaccination is not considered to cause any serious side effects.
Guillain-Barré SyndromeThe 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 TrialsThe 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.