Lentis/The HPV Vaccine

Introduction
Vaccinations for Human papillomavirus (HPV) are effective at preventing this sexually transmitted infection. However, due to lack of access, unequal effectiveness, and unfounded fears of side effects, the vaccine is not as effective as it could be at protecting those susceptible to the virus.

Overview
Human papillomavirus (HPV) is the most common sexually transmitted infection. There are over 100 different strains of HPV, fourteen million new cases each year, and 79 million Americans currently infected. 90% of HPV infections clear up within two years, infections that last over two years have an elevated risk of resulting in cervical, anal, penile, or vaginal cancer, or genital warts. Transmission can be prevented via safe sex practices and the HPV vaccine.

There are three HPV vaccines: Cervarix, Gardasil, and Gardasil 9. Cervarix is a bivalent vaccine that protects against types 16 and 18; Gardasil is a tetravalent vaccine which protects against types 6, 11, 16, and 18; and Gardasil 9 is 9-valent vaccine which protects against types 6, 11, 16, 18, 31, 33, 34, 45, 52, and 58. Types 16 and 18 are most likely to cause HPV related cancers and make up 70% of cervical cancer cases. Gardasil and Gardasil 9 are administered in 3 doses, and protect against types 6 and 11 which make up for 90% of genital warts cases. Side effects include pain, swelling, fever, fatigue, or headache.

Inequality in Access
Overall, initiation and completion of the HPV vaccine series is low amongst US adolescents. 53 percent of adolescent girls have received the recommended doses, while only 44 percent of adolescent boys have received them. African American and Hispanic females are under-vaccinated in comparison to white females, but cervical cancer incidence and mortality is higher among African Americans and Latinas than whites.

Gardasil was initially only recommended for young women, so gaps in vaccination rates between men and women may be due to doctors still not offering the vaccine to male patients. Disparities between Hispanic females’ and white females’ vaccination rates may be explained by lack of access to health insurance or inconsistent sources for healthcare. African American women display more negative attitudes towards the vaccine, and college-age African American women appear to have a lower perceived risk for HPV infection. It is hypothesized that African American women could become more likely to receive vaccination if it is recommended by a healthcare provider. Further research is needed to determine how uptake can be improved.

Inequality in Effectiveness
Black women are 40 percent more likely to develop cervical cancer as a direct result of HPV, and they are twice as likely to die from it when compared to white women. This is often attributed to differences in access to healthcare, but a study of 572 participants conducted by researchers at Duke University found that biological factors play a major role in the difference. The only two HPV vaccines on the market, Gardasil and Cervarix, protect against the cancerous strains 16 and 18, but in the aforementioned study, black women were found to be two times less likely to have the strains 16 and 18, which cause 70 percent of all cervical cancers. Below is a table of the most common strains of HPV by race.

Clinical Trial Demographics
The underrepresentation of ethnic and racial minorities in previous HPV participant pools could be a cause for the gap in effectiveness of current vaccines. Minorities only make up 10 percent of all clinical trial participants, but representation in these trials is necessary to ensure that treatments are relevant to all populations. Congress passed the National Institutes of Health Revitalization Act in 1993 to establish guidelines on including women and minorities in clinical trial populations. This legislation only applies to studies that receive funding from the National Institute of Health (only 6 percent of all clinical trial studies) and has done little to increase minority participation in clinical trials in the past 25 years. Efforts to increase recruitment of clinical trial participants face obstacles such as poverty, geographic proximity, misinformation, distrust, and language barriers.

Gardasil 9
In December of 2014, the Gardasil 9 vaccine was approved for men and women ages 9 to 45. Before this, Cervarix and Gardasil were the only HPV vaccines available. Gardasil 9 protects against 7 different cancer causing strains: 16, 18, 31, 33, 45, 52 and 58. While this vaccine covers many more strains than, particularly strains prevalent in black populations, there are still common cancerous strains that are not protected against by any vaccine.

Mandatory Government Enforcement
The first HPV vaccine was introduced in 2006. In 2007, 24 states introduced legislation to make the vaccine mandatory for school attendance; only Virginia, Rhode Island and Washington successfully passed legislation.

Objections
In 2007, The National Vaccine Information Center’s president released a statement stating that they opposed the HPV vaccine mandates due to a lack of scientific evidence indicating safety, little or no evidence that 11 year old girls will actually be protected from cervical cancer in the future, and that 90% of HPV cases clear up on their own. Deepi Brar, a parent, felt that states were overstepping their authority, stating that “Since it's not a communicable disease you can catch in a classroom setting, it's not really the school's place to tell parents that they must go out and have their children vaccinated.” Some groups, such as The Texas Eagle Forum, opposed the mandate citing “inadequate testing” as the reason. The American Academy of Pediatrics saw the policies as unethical, since many were gender specific and only required vaccination of young girls. The high cost of the vaccine, $360 without insurance, made many question how mandatory vaccination would be financed, and whether money or altruism was the reason behind the Merck campaign.

Altruism or Money
Merck, the manufacturer of Gardasil, was forced to remove their painkiller Vioxx from shelves in 2004 because it was shown to pose a substantial heart risk. Between 2004 and 2006, Merck’s marketers had sowed fear about HPV into the American public through ads without mentioning their upcoming vaccine. By 2006, Merck had lost a lot of money, was facing thousands of lawsuits, and was aggressively lobbying to make Gardasil mandatory. Some began to call Gardasil the “Help Merck Pay for Vioxx Vaccine.”

Public Concerns
Since the release of the HPV vaccine, some parents have refused to vaccinate their teenage children due to fear of increased promiscuity or dramatic physical side effects.

Fears of Promiscuity
In 2012, a US poll showed that only 45% of parents support administration of the HPV vaccine without parental consent, citing fear of increased promiscuity as a primary reason. However, a 2015 study conducted at the University of Southern California Medical School examined vaccinated and unvaccinated girls, charting their rates of STI contraction before and after receiving the vaccine. The study found no difference in increase in STI rate between the two test groups, concluding that the HPV vaccine does not cause increased promiscuity.

Neurological Damage
In 2008, 13 year old Jenny Tetlock was paralyzed after receiving the Gardisil vaccine. Her father began publicly looking for answers. In his search, he found no evidence that the Gardisil vaccine had caused Jenny’s paralysis. His publicly-voiced suspicions that Gardisil was the culprit spread distrust of the vaccine.

Many parents believe that the vaccine causes brain damage and paralysis: some are vocal about their concerns. These parents have formed various Facebook groups, including one called “ Reactions and Effects of Gardisil Resulting in Extreme Trauma (R.E.G.R.E.T) HPV Gardisil Vaccine Support Group, which has amassed about 3,300 followers.

Ovarian Failure
A commonly feared (and untrue) side effect of the HPV vaccine is ovarian defect. In 2012, a 16 year old girl, who had been menstruating for 3 years, experienced ovarian failure after receiving the HPV vaccine. Three similar cases were reported that year, leading many to believe the vaccine was the cause. However, a study conducted at the Kaiser Permanente Northwest Center for Health Research in Portland found no significant correlation between the vaccine and ovarian failure. This study tracked incidence of ovarian failure in vaccinated and unvaccinated women and found that the two groups had the same rate of incidence of ovarian failure.

Misinformation
Untrustworthy news sources spread misinformation about the HPV vaccine. In one study, published in Scientific Reports, researchers at Tokyo Medical University injected mice with larger than normal doses of the HPV vaccine, along with pertussis toxin. The mice developed neurological defects. A group of HPV experts at the University of Antwerp protested the study’s inclusion in Scientific Reports, explaining that the study was a setup and that the only reason to administer the pertussis toxin was to cause neurological defects that they could blame on the HPV vaccine. This study, though not legitimate, damaged the vaccine's reputation. 18 months after publishing, Scientific Reports retracted the paper.

Many such studies appear on social media. One article, titled "New Concerns about the Human Papillomavirus Vaccine", circulated in 2016. The article was debunked: the American College of Pediatrics, who published it, is not the accepted pediatrician's group. The article's evidence was sparse, citing only 6 cases of neurological damage following HPV vaccination.

Medical Evidence and Advice
The CDC and FDA confirm that the only notable side effect of the HPV vaccine is syncope (fainting). The American Academy of Pediatrics, the accepted pediatrician's group, promotes the vaccination of teenage girls against HPV. Their only health advisory is that that patients should sit or lie for about 15 minutes after receiving the vaccine to avoid fainting.