Is the HPV Vaccine Gardasil Dangerous?

A viral Facebook post claimed that Gardasil, a human papillomavirus (HPV) vaccine, caused 40 deaths in its original clinical trials. The post further claims that aluminum was used as a placebo in the drug trials, “meaning all clinical trial participants were injected with a powerful neurotoxin.” The post alleges that aluminum was used so as “to try to make adverse events between the gardasil group and the ‘placebo’ group seem insignificant.” The alleged source of information for these claims is the manufacture package insert for Gardasil, which is linked to at the end of the post.

However, reading through the manufacture insert on the FDA’s website shows important context was left out: While 40 out of the 29,323 participants in the clinical trials did pass away, more than half of the causes of death have no connection with the vaccine. There were seven clinical trials performed, five of which used amorphous aluminum hydroxyphosphate sulfate (AAHS) for the control group placebo, one of which used a saline solution, and one of which had no control. The most common cause of death across these seven trials was car accidents, which resulted in the passing of nine participants. Another four died because of gunshot wounds. Eight participants died because of drug overdoses or suicide. And while some vaccination skeptics argue that those suicides and drug use could be due to the vaccine causing mental health issues, six of the participants who died because of overdose or suicide had taken the placebo. What’s more, Dr. Paul Offit, inventor of the rotavirus vaccine and an expert on vaccines and immunology at the Children’s Hospital of Philadelphia, told The Dispatch Fact Check that “Post-licensure studies have shown no increase in mental health problems.”

Of the remaining 19 deaths, there was no consistency in the causes, with two participants passing away because of pulmonary embolism/deep vein thrombosis (one of whom took Gardasil, one of whom was given AAHS), two participants from the Gardasil group dying because of sepsis, and 10 others from the Gardasil group dying from 10 different health problems. Four from the AAHS control group died from four different health issues and one from the saline group died from medulloblastoma. The package insert notes that “The events reported were consistent with events expected in healthy adolescent and adult populations,” meaning that the deaths that occurred, and their causes, occur in these numbers in the general population as well.

The description of amorphous aluminum hydroxyphosphate sulfate as a “neurotoxin” is also incorrect. While aluminum can be toxic in high doses, the amount necessary for toxicity depends on how it is taken into the human body. For example, the Occupational Safety and Health Administration set a legal limit of 15 micrograms per cubic meter of total aluminum dust in the air averaged over an 8 hour work day,” but the Food and Drug Administration has set the limit for the amount present in bottled water as 0.2 milligrams per liter. The FDA limit for vaccines is 0.85 milligrams to 1.25 milligrams per dose. The amount of aluminum in vaccines is so low, that according to the Children’s Hospital of Philadelphia infants ingest more aluminum through their diet in their first six months than they do from all their recommended vaccines during that time. The AAHS control in the Gardasil clinical trials was 225 micrograms or .225 milligrams per dose, well below the FDA’s set limit.