Do the benefits outweigh the risks?
Kathryn E. Vinson, MS, CCRC
Conversations about vaccines always tend to bring about strong opinions, whether they be pro or con. When I was a baby clinical research coordinator, my boss was so excited that we had the opportunity to work on a vaccine trial that could help prevent cervical cancer. I too was thrilled – I mean, who wouldn’t love to work on a trial that could help eradicate some cancers? Ultimately, our site wasn’t selected by the pharma company to work on that study, but this vaccine was eventually approved by the FDA and many other regulatory bodies worldwide. We now know it as Garadasil®, the HPV vaccine, or the cervical cancer vaccine, but the truth is that it can protect against much more than cervical cancer. I want to take some time today to talk with you about what the data shows, not what we see on social media. Before we go any further – this is neither an endorsement nor a bashing of this vaccine – this is me laying out the data so that you can make an informed decision based upon facts.
What is HPV?
Human papillomavirus, or HPV as it is more commonly known, is actually a collection of more than 100 strains of HPV. Some of theses strains are relatively harmless, causing no symptoms, some cause warts on the hands and feet, while others cause genital warts, cervical cancer, anal cancer, and oropharyngeal cancers. Some estimates tell us that as many as 90% of the population will become infected with some form of HPV during their lifetime, with the 40 strains that are have the potential to cause cancer being sexually transmitted.
Garadasil® was first approved by the FDA in 2006. At that time, it protected against strains 6, 11, 16, and 18. Later in 2014 Garadasil9® was released, protecting against five additional strains of HPV: 31, 33, 45, 52 and 58. Both versions of the vaccine have been evaluated as safe by the FDA and other similar regulatory bodies around the world. The most commonly reported side effects are similar to those of other vaccines: pain, swelling, and itching at the injection site, headache, dizziness, nausea, and vomiting. In 2014, the CDC released a detailed report on information received about the four-strain version of the vaccine. At the time of the report 67 million doses had been administered, with roughly 25,000 reports of side effects – that is abut 0.03% of vaccines given. Of those side effects, 92.4% were deemed mild to moderate, with 7.6% being rated as severe, or about 1,900. The majority of the severe side effects listed were headache, nausea, vomiting, and fever.
During the same time frame (2006-2014), 96 deaths were reported, but only 47 were able to be confirmed by the receipt of death certificates, autopsy reports, or certifications from a medical professional. I know this sounds very scary, as even one death is one too many, but I want you to read the exact language from the CDC report: “Causes of the confirmed death reports included bacterial meningitis, viral myocarditis, pulmonary embolism, diabetic ketoacidosis, and seizure disorder. Detailed review of every report of death following HPV4 alone or in combination with other vaccines by medical officers from CDC and FDA identified no pattern of occurrence of death with respect to time after vaccination, vaccine dose number, combination of vaccines administered, or diagnosis at death that would suggest a causal association with HPV4.” That last part of the statement is important: after the doctors and scientists at the FDA and CDC reviewed all available data, they could not find anything that linked these deaths together, including the vaccine.
So, we have talked about the safety data related to the vaccine, but what about its efficacy? Does it even work? A team from the University of Copenhagen reviewed data from two different birth cohorts – a group of women born in 1983, and thus too old to have received the vaccine, and a group of women born in 1993, the first group of women in Denmark to have received the vaccine as teens. When the researchers compared levels of severe cervical dysplasia (a precursor to cervical cancer), they found that the vaccinated group was 40% less likely to show severe dysplasia than the non-vaccinated group. The researchers feel that this efficacy will increase in later cohorts, as the 1993 group was vaccinated at age 15, while current recommendations say to vaccinate at age 12.
The decision to vaccinate your son or daughter against HPV is a personal one – a decision that only you can make. As more and more possible vaccines targeting cancer are being developed (check out our article on Custom cancer vaccines), it is vital for us to arm ourselves with hard data from reliable sources, so we can make informed decisions.
As always, much love, abundant blessings, and many prayers to all of the cancer warriors and their families.