In a recent guest editorial that I penned for BioCentury, I referenced that a parent’s choice whether or not to vaccinate their child against the human papillomavirus (HPV) isn’t a “risk-free” choice. Every drug has risks – consider the following statement by the U.S. Food and Drug Administration (FDA): “although medicines can make you feel better and help you get well, it’s important to know that all medicines, both prescription and over-the-counter, have risks as well as benefits.” I would also point out that there are risks in forgoing a medication.
Let’s take a look at the HPV vaccine’s side-effects according to the prescribing information for Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). The most common side effects include pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot, headache, fever, nausea, dizziness, tiredness, diarrhea, abdominal pain, and sore throat. These are adverse events disclosed by the sponsor (Merck & Co., Inc.) to the FDA from completed clinical trials of Gardasil 9. Since licensure in 2006, over 270 million doses of HPV vaccines have been distributed and the sponsors are obligated to report any new side effects to the FDA.
What’s that you say? You don’t trust the pharmaceutical industry? The Global Advisory Committee on Vaccine Safety (GACVS), an independent expert clinical and scientific advisory body that provides the World Health Organization (WHO) with scientifically rigorous advice on vaccine safety issues of potential global importance, first reviewed the safety data for HPV vaccines in 2007 and subsequently in 2008, 2009, 2013, 2014, 2015, and 2017. In each period, the GACVS examined various vaccine specific safety issues, such as links to Guillain-Barré syndrome (GBS) and other autoimmune safety issues. No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. According to the WHO, there are now accumulated safety studies that include several million persons and which compare the risks for a wide range of health outcomes in vaccinated and unvaccinated subjects.
Early on, the GACVS was presented with signals related to anaphylaxis and syncope related to the HPV vaccines. According to the GACVS, the risk of anaphylaxis from HPV vaccines has been characterized as less than 2 cases per 1,000,000 doses, and syncope was established as a common anxiety or stress- related reaction to the injection. Anaphylaxis is a severe allergic reaction that needs to be treated right away with an epinephrine (adrenaline) shot. Anaphylaxis is rare, and most people recover from it. Syncope, also known as fainting, is a loss of consciousness and muscle strength characterized by a fast onset, short duration, and spontaneous recovery. It is caused by a decrease in blood flow to the brain, usually from low blood pressure. For these reasons, the prescribing information for Gardasil 9 recommends observation of the individual for 15 minutes after administration.
Next, let’s consider the risks of not getting vaccinated against HPV. Again, according to the prescribing information for Gardasil 9, the vaccine helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV. Gardasil 9 also helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types. Accordingly, individuals who do not get vaccinated against HPV are at risk for the aforementioned cancers and genital warts.
In addition, the 9 types of HPV that infect the genital areas can also infect the mouth and throat (called oropharyngeal cancers). HPV is thought to cause 70% of oropharyngeal cancers in the United States, with HPV type 16 causing 60% of all oropharyngeal cancers. The HPV vaccine was originally developed to prevent cervical and other less-common genital cancers and has been shown in clinical studies to prevent cervical and other precancers. However, HPV vaccines could also prevent oropharyngeal cancers because the vaccines prevent infection with HPV types that can cause oropharyngeal cancers.
HPV vaccines were not available until I was age 38, which is well-beyond the upper age limit of 26 when the vaccines are considered effective. In late 2015, I was diagnosed with poorly differentiated, oropharyngeal squamous cell carcinoma, HPV type 16 related. My three treatment regimens thus far have included: chemoradiation, immunotherapy and currently chemotherapy.
My diagnosis is terminal, so “death” would be the primary side effect from the disease that I would gladly forgo in favor of any of the aforementioned HPV vaccine side effects. Setting my grim humor aside for the moment, there are more than a dozen other side-effects that I have personally experienced to date from either cancer or its treatment (see accompanying image for details). And these side-effects don’t include others that I haven’t personally experienced, such as kidney damage.
I’m an advocate of HPV vaccination and strongly encourage parents to speak with a physician when it comes to deciding whether or not to vaccinate a child. The purpose of this blog post is to underscore that deciding not to vaccinate against HPV isn’t a risk-free decision. In my experience, the diagnosis of any one of the six cancers resulting from HPV infection is associated with plenty of important risks for parents to also consider.