Let me start right from the top — no link has been found between the HPV vaccine and premature ovarian failure. But that didn’t stop some “researchers” from dumpster-diving into the VAERS database to try to establish a link between the HPV vaccine and premature ovarian failure.
Since I enjoy doing this, I am going to review this paper and tell you, once again, why good vaccine research should never rely upon VAERS.
All about HPV and HPV vaccines
I know I cut and paste this section to every article I write about HPV vaccines, but it’s the first step to HPV vaccine myth debunking. Some readers may be coming here for the first time, and they ought to know just how the HPV vaccine prevents cancer.
However, I try to update this section when necessary with new information about either the disease or the vaccine. If you’ve read this section 47 times, just skip down to the next section where I discuss the key point of this article.
Genital and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA. HPV is generally transmitted from personal contact during vaginal, anal, or oral sex.
It’s important to note that there are more than 150 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Of those 40 strains, most are fairly rare.
Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:
In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 46,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.
There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline, produced Cervarix, a bivalent (protects against two HPV strains) vaccine. It has been withdrawn from the US market (although available in many other markets), because of the competition from the quadrivalent (immunizes against four different HPV strains) and 9-valent (against nine HPV strains) Gardasil vaccines.
Merck manufactures Gardasil, probably the most popular HPV vaccine in the world. The first version of the vaccine, quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. In Europe and other markets, Gardasil is known as Silgard.
The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine, protecting against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.
Gardasil is one of the easiest and best ways to prevent a few dangerous and, to abuse the definition slightly, common cancers that afflict men and women. Without a doubt, the HPV vaccine prevents cancer.
Currently, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.
Let me sum this all up so that if you come away from this section with nothing else, you get this summary. HPV is a sexually transmitted disease. HPV causes 46,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, which means you are protected from these cancers.
What is premature ovarian failure?
Premature ovarian failure (POF), also known as primary ovarian insufficiency, happens when a woman’s ovaries stop working normally before she is 40. For women with POI, irregular periods and reduced fertility start before the age of 40. Sometimes it can start as early as the teenage years.
Although POF is not well understood, it appears to be related to the follicles, which are small sacs in the ovaries in which eggs develop before fertilization. In POF, these follicles either don’t work properly or disappear.
The cause of POF is unknown. However, it may be linked to the following diseases and conditions:
- Genetic disorders such as Fragile X syndrome and Turner syndrome
- A low number of follicles
- Autoimmune diseases, including thyroiditis and Addison disease
- Chemotherapy or radiation therapy
- Metabolic disorders
- Toxins, such as cigarette smoke, chemicals, and pesticides
There is currently no proven treatment for premature ovarian failure.
The published paper
In a paper by Collins Tatang and colleagues, published 12 September 2021 in Drugs – Real World Outcomes, a very low impact factor journal, the researchers scoured the Vaccine Adverse Events Reporting System (VAERS) database in an attempt to show a correlation between HPV vaccines and primary ovarian failure.
Before I critique their methods and analyses, I want to take a meta-view of the research. First, if they really had done a good job in establishing a link between the HPV vaccine and POF, that would be very important research. So, why would they publish it in a low-ranked journal rather in other journals that are important outlets for this type of research, such as Vaccine or Journal of Infectious Diseases, both of which have higher impact factors, and publish articles like this one? They didn’t, or maybe they tried and the research was seen as useless because it used VAERS, instead of much better databases for vaccine safety.
Second, the first and last authors, Collins Tatang and Yola Moride, respectively, have no known research in vaccines. Nothing. Furthermore, Dr. Moride has recently published a paper about homeopathy which appears to endorse one of the quack “clinical trials” for homeopathic potions. Homeopathy is nothing but water, a pseudoscientific concept that relies upon magical thinking. I do not trust any “scientist” who fails to rip apart homeopathy for the scam that it is.
Enough with the lack of vaccine science in the key authors. Let’s take a look at their methods. They searched the VAERS database for “terms related to POF and identified in VAERS all POF reports in women less than 40 years of age between 2 July 1990 and 14 May 2018, followed by a review of narratives to confirm the cases.”
I’ve written a lot about how useless VAERS is for doing vaccine research. Basically, it is a self-reported system that cannot establish a link between a vaccine and an adverse effect. No real epidemiologist would ever use VAERS to do anything more than making broad observations.
In this case, the authors reviewed POF cases over 30 years ago starting in July 1990 through May 2018. From this data, they found 228,341 eligible POF reports, with 281 (0.1%) suspected to be associated with HPV vaccines. Since VAERS rarely includes medical history and reports, I cannot understand how they can claim that those 281 could be associated with the HPV vaccine.
They also claimed that “POF events significantly increased after the first HPV vaccine launch in 2006 with 22.2 POF cases/year up from 1.4 POF cases/year before the launch.” That seems serious, but there are lots of reasons to dismiss it:
- The anti-vaccine world despises the HPV vaccine more than anything except the recent COVID-19 vaccines. Reports may be up because people are focused on the HPV vaccine and reproductive issues.
- As I wrote above, VAERS does not contain medical histories and reports, so we don’t know if it is really POF that’s being reported.
- They made no comparison to real world data — the risk of POF in the general population of women aged 16-40 is around 1%. Some studies suggest rates of 22 cases of POI per 100 000 person years in girls 15–19 years of age in the era prior to HPV vaccine introduction. In other words, the authors took data from a database not meant for this type of research, and they failed to look at the unvaccinated population to see if POF seemed higher or lower in the vaccine group.
This is why researchers use a database like the Vaccine Safety Datalink, or VSD, a large database of medical data which includes vaccination histories, health outcomes, and subject characteristics. The VSD database contains data compiled from surveillance on more than seven million people in the United States.
The researchers could have divided that database into two groups, one with POF and another without, and checked vaccination status. Or they could have divided it into vaccinated and unvaccinated groups, then determined the risk of POF in each.
Oh, wait, someone has done that, and they found no difference in risk of POF between HPV vaccinated and unvaccinated groups of women. In fact, I reviewed all of the articles that showed that there is no link between primary ovarian failure and the HPV vaccines. Furthermore, the authors didn’t even cite the Hviid article which clearly dismisses any link between POV and HPV vaccines — that is a troubling oversight for their “research.”
I will take case-control and cohort studies over VAERS dumpster diving any day when trying to ascertain whether an adverse event is linked to a vaccine.
To be fair, the study authors may be aware of the weakness of the VAERS databases. They concluded that”
Our study suggests the presence of a potential safety signal of POF associated with HPV vaccination, which may only be partly attributed to notoriety bias.
Yes, VAERS is only useful for safety signals. They then suggested more research should be done to investigate the link. That has been done, and no link was found. None.
Summary
Of course, anti-vaxxers will use this study as “proof” that the HPV vaccine causes premature ovarian failure, when, in fact, the paper does not support such a conclusion. It does not show correlation, let alone causation. Furthermore,
At this time, this paper notwithstanding, there is simply no evidence of a link between HPV vaccines and POF. In fact, at this time, most of the research has definitely shown that there is no link.
I’m going to give a benefit of the doubt to these researchers who have unwittingly provided ammunition for those who are opposed to this cancer-prevention vaccine. None of the authors appears to be well-versed in vaccinology, so they may have been unaware of the quality of VAERS data and were also unaware of more powerful tools that could have helped produce a much more useful research article.
The only conclusion I can make is that this article tells us nothing about the safety of the HPV vaccine and will only become a tool for the anti-vaxxers for their endless tropes and myths about the vaccine.
Citations
- Hawkes D, Lea CE, Berryman MJ. Answering human papillomavirus vaccine concerns; a matter of science and time. Infect Agent Cancer. 2013 Jun 12;8(1):22. doi: 10.1186/1750-9378-8-22. PMID: 23758825; PMCID: PMC3691750.
- Hviid A, Myrup Thiesson E. Association Between Human Papillomavirus Vaccination and Primary Ovarian Insufficiency in a Nationwide Cohort. JAMA Netw Open. 2021 Aug 2;4(8):e2120391. doi: 10.1001/jamanetworkopen.2021.20391. PMID: 34436612.
- Moride Y. Methodological Considerations in the Assessment of Effectiveness of Homeopathic Care: A Critical Review of the EPI3 Study. Homeopathy. 2021 Sep 14. doi: 10.1055/s-0041-1732335. Epub ahead of print. PMID: 34521145.
- Rudnicka E, Kruszewska J, Klicka K, Kowalczyk J, Grymowicz M, Skórska J, Pięta W, Smolarczyk R. Premature ovarian insufficiency – aetiopathology, epidemiology, and diagnostic evaluation. Prz Menopauzalny. 2018 Sep;17(3):105-108. doi: 10.5114/pm.2018.78550. Epub 2018 Sep 30. PMID: 30357004; PMCID: PMC6196779.
- Tatang C, Arredondo Bisonó T, Bergamasco A, Salvo F, Costa Clemens SA, Moride Y. Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System. Drugs Real World Outcomes. 2022 Mar;9(1):79-90. doi: 10.1007/s40801-021-00271-6. Epub 2021 Sep 12. PMID: 34510402; PMCID: PMC8844335.
