Does Gardasil (Human Papillomavirus vaccine) cause autoimmune disease?

From the Guidelines

No, there is no convincing evidence that Gardasil causes autoimmune disease. Gardasil, a vaccine that protects against human papillomavirus (HPV) and helps prevent certain cancers, has been extensively studied in clinical trials and post-marketing surveillance involving millions of doses. Multiple large-scale safety studies, including population-based studies in countries with comprehensive health registries, have not found a causal relationship between Gardasil vaccination and the development of autoimmune conditions, as noted in a study published in 2018 1. While temporal associations (autoimmune conditions appearing after vaccination) have occasionally been reported, these occurrences match the background rate expected in the general population. The immune response triggered by Gardasil is targeted and similar to other vaccines, designed to create antibodies against specific HPV proteins without disrupting normal immune function. Some of the key points to consider include:

• The vaccine's safety profile has been consistently monitored by health authorities worldwide, and the benefits of preventing HPV-related cancers substantially outweigh any theoretical risks.
• The most common side effects of Gardasil are headache, which occurs in up to one half of patients, and syncope, which has been reported following other intramuscular vaccinations, as noted in a study published in 2015 1.
• There is no severe complication directly linked to HPV vaccine administration, but it is contraindicated in individuals with a yeast allergy. The vaccine contains no viral DNA and is not infectious, as noted in a study published in 2007 1. The current evidence supports the use of Gardasil as a safe and effective vaccine for the prevention of HPV-related cancers, and anyone with specific concerns about Gardasil should discuss them with their healthcare provider.

From the FDA Drug Label

Systemic Autoimmune Disorders In all of the clinical trials with GARDASIL 9 subjects were evaluated for new medical conditions potentially indicative of a systemic autoimmune disorder. In total, 2. 2% (351/15,703) of GARDASIL 9 recipients and 3. 3% (240/7,378) of GARDASIL recipients reported new medical conditions potentially indicative of systemic autoimmune disorders, which were similar to rates reported following GARDASIL, AAHS control, or saline placebo in historical clinical trials

The evidence from the clinical trials does not suggest a significant increase in the risk of autoimmune disease associated with the use of GARDASIL 9 compared to the control groups. The rates of new medical conditions potentially indicative of systemic autoimmune disorders were similar between GARDASIL 9 recipients and control groups. However, the data does not provide conclusive evidence to rule out the possibility of autoimmune disease caused by GARDASIL 9. Therefore, a conservative clinical decision would be to approach this question with caution and consider that the current evidence is not sufficient to establish a definitive link between GARDASIL 9 and autoimmune disease 2.

From the Research

Autoimmune Disease and Gardasil

• The relationship between Gardasil, a human papillomavirus (HPV) vaccine, and autoimmune disease has been studied in several research papers 3, 4, 5, 6, 7.
• A 2013 study published in the American Journal of Reproductive Immunology found that three young women developed primary ovarian failure after receiving the HPV vaccine, suggesting a potential link between the vaccine and autoimmune response 3.
• However, a 2015 systematic review published in Vaccine found that HPV vaccines are generally safe and effective in patients with autoimmune diseases, although some concerns remain regarding concomitant therapies and disease exacerbation 4.
• A 2018 meta-analysis published in the Journal of Preventive Medicine and Hygiene found no correlation between HPV vaccines and autoimmune disorders, with a pooled odds ratio of 1.038 (95% CI 0.689-1.562) 5.
• Another study published in 2014 in Autoimmunity Reviews analyzed case reports and studies on the relationship between HPV vaccine and autoimmune diseases, but found no conclusive evidence of a causal relationship 6.
• A 2019 systematic review and meta-analysis published in Vaccine found that HPV vaccination was not associated with an increased risk of autoimmune disorders, with an odds ratio of 1.003 (95% CI 0.95-1.06) 7.

Key Findings

• The majority of studies found no significant association between Gardasil and autoimmune disease 4, 5, 7.
• Some studies suggest that the vaccine may trigger an autoimmune response in rare cases 3.
• The risk vs. benefit of vaccination is still being evaluated, and ongoing vigilance for safety is important 6.