Is the human papillomavirus vaccine Gardasil causing systemic autoimmune disorder in young girls due to the aluminum adjuvant it contains? No, that's not true: The safety of the vaccine is rigorously monitored by both the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. According to the European Medicines Agency, there is no credible evidence supporting a causal link between the HPV vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and the development of autoimmune diseases. The consensus from regulatory agencies is that the benefits of such vaccination in preventing cervical and other cancers far outweigh any potential risks.
The claim appeared in a video (archived here) on TikTok on January 21, 2024. It began (translated from Croatian to English by Lead Stories staff):
But here is what they did, they compared getting the vaccine with giving it to about 10,000 girls who got not a placebo, not a water injection, not a saline injection, but an injection of the most active ingredient in the vaccine, the aluminum adjuvant. It is called the AAHS. It is a proprietary aluminum adjuvant that was built by Merck. And what it is essentially, it is designed to cause an immune reaction where it is injected. When you think of a can, why can you store something in a can forever? Because aluminum kills everything. It is cytotoxic, it is neurotoxic. ... They are suspected to cause harm amongst other parts of the Gardasil vaccine, the HPV vaccine.
This is what the post looked like on TikTok at the time of writing:
(Source: TikTok screenshot taken on Wed Jan 24 08:56:11 2024 UTC)
The video shows a clip from the Slobodni podcast ("Free podcast"), hosted by Andrija Klarić. Klarić is widely recognized for actively promoting conspiracy theories. He has accumulated numerous police reports for orchestrating anti-COVID-19 protests during the pandemic (archived here), along with documented fines totaling 5,000 euros ($5,371) (archived here). His podcast, notorious for hosting pseudoscientists, is recognized for disseminating misleading information.
Statements presented in this podcast episode are inaccurate. HPV, or the human papillomavirus (archived here), comprises over 100 variants. Some types commonly lead to the formation of skin or mucous membrane growths (warts), while others are associated with the development of cervical, vaginal and vulvar cancers in women, as well as penile cancer in men. The virus is transmitted through sexual contact or skin-to-skin contact. Vaccines (archived here) have been developed to protect against specific HPV strains, reducing the risk of genital warts and cervical cancer. HPV vaccination can commence as early as 9 years old.
The Centers for Disease Control and Prevention (CDC) recommends a two-dose HPV vaccine series administered six to 12 months apart for 11- to 12-year-olds (archived here). For those initiating the vaccine series between ages 15 and 26, a three-dose regimen is advised. These guidelines aim to maximize the effectiveness of HPV vaccination in preventing associated health risks (archived here).
As with all approved vaccines, CDC and FDA closely monitor the safety of HPV vaccines. Any detected safety concerns are reported to health officials, healthcare professionals, and the public.
An adjuvant (archived here) refers to a substance or combination of substances that enhances the efficacy or potency of certain drugs. Aluminum salts, including aluminum hydroxide, aluminum phosphate and aluminum potassium sulfate, have been safely incorporated into vaccines for many decades. Vaccines containing aluminum adjuvants (archived here), undergo rigorous clinical testing and trials before approval, with continuous monitoring post-approval.
These adjuvants have a longstanding history in vaccines, having been safely administered to more than 3 billion people (archived here). Furthermore, a study conducted in 2023 (archived here) on aluminum adjuvants concluded that they are safe for use:
Aluminum-containing adjuvants have been used for over 80 years in human vaccines, with millions of doses injected annually in infants, adolescents, and adults. Based on this unsurpassed historical record, aluminum adjuvants are regarded as safe and well tolerated. A small proportion of injected individuals may develop granulomas or contact hypersensitivity to aluminum following injection of aluminum-adjuvanted vaccines. Aluminum is a widespread element in the environment and is present in food, personal care products, and medications. There is no evidence that injection of aluminum-containing vaccines increases the aluminum levels in blood above baseline or minimum risk levels and causes systemic disease or neurologic disorders.
The Gardasil vaccine (archived here) contains no more than 0.5 milligrams of aluminum per dose (archived here). This amount is considerably lower than the daily aluminum intake of 7 to 9 milligrams typically ingested by a typical adult. A 2018 study titled "HPV vaccine and autoimmune diseases: systematic review and meta-analysis of the literature" (archived here), conducted a meta-analysis of six studies focused on the bivalent and quadrivalent HPV vaccine. The findings of this analysis revealed no correlation between autoimmune disorders and HPV vaccines.
The total number of subjects included in the meta-analysis comprised 243,289 in the vaccine group and 248,820 in the control groups. Four of the six trials had a Jadad score of 3 or 4 indicating an adequate trial quality. The most frequent autoimmune diseases observed across the six studies were musculoskeletal,CNS conditions, and endocrinological conditions. The results of the meta-analysis demonstrated no correlation between autoimmune disorders and HPV vaccines.
Additional research from 2012 (archived here) and 2014 (archived here) demonstrated that women and girls who received the Gardasil shot were not at a higher risk of developing autoimmune disorders compared to those who were unvaccinated. Likewise, a study conducted in 2015 (archived here) found no increased likelihood of women and girls who received Gardasil developing multiple sclerosis or similar diseases compared to their unvaccinated counterparts.
