Gardasil Controversy FAQ

What is Behind the Gardasil Controversy?

With so many questions surrounding the Gardasil HPV vaccine litigation, we created the following FAQ page to help answer some of your questions.

If you still have questions or would like to speak with an experienced Gardasil lawyer about filing a claim, give us a call at (855) 948-5098 today or fill out our contact form.

What is Gardasil?

Gardasil is a vaccine now approved for use by adolescents, men and women between the ages of 9 and 45, to prevent sexually transmitted infection from several types of human papillomavirus (HPV). Certain types of HPV are associated with cervical cancer and Gardasil was heavily promoted as a necessary protection against cervical cancer. The vaccine later received FDA approval for protection against other cancers and diseases in males and females in the same age range.

There are over 200 types of HPV, each with a number. Gardasil was designed to protect against certain types of HPV. High-risk HPV is associated with potentially pre-cancerous cell growth on the cervix. Low-risk types pose little or no risk of cervical cancer, but they are associated with skin and genital warts.

Gardasil 4

Gardasil “quadrivalent,” or Gardasil 4, was designed to prevent infection from two of the high-risk HPV types (16 and 18) and two low-risk HPV types (6 and 11). The vaccine was initially approved for girls and women ages 9-26. The American Committee on Immunization Practices (ACIP) recommended in 2007 that Gardasil become a routine vaccination for girls ages 11-12. The Gardasil 4 vaccine is no longer available in the U.S. It was replaced by Gardasil 9.

Gardasil 9

Gardasil 9 was designed to prevent infection from seven types of high-risk HPV (16, 18, 31, 33, 45, 52, 58) and two low-risk types (6 and 11). Since May 2017, it has been the only HPV vaccine available in the U.S. In 2018, the U.S. Food and Drug Administration (FDA) approved expanded use of the Gardasil 9 vaccine to include individuals between the ages of 27 and 45.

Who Makes Gardasil?

Merck & Co. is the Gardasil manufacturer.

When Was Gardasil Approved?

The FDA approved the quadrivalent Gardasil 4 in 2006 after being fast-tracked for approval (the process only took six months). Gardasil 9 was approved in 2014.

Does HPV Cause Cancer?

More than 90% of new HPV infections, including those caused by high-risk HPV types, go away naturally in 1 to 2 years. Clearance of the infection usually occurs within 6 months. Even when HPV does not resolve and causes abnormal changes in cervical cells, those “lesions,” as they are called, rarely progress to cancer.

Gardasil Makes Good Vaccines Look Bad

There is currently a great deal of controversy surrounding vaccines. Our firm wishes to stress that we are not against vaccines. They have the potential to eradicate disease and save millions of lives. We are, however, against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. We have always fought-- and will continue to fight-- for the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, or medical device. We will work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.

How Do Vaccines Work?

When a virus attacks the body, the body’s immune system responds by creating antibodies – proteins that attach to the virus and mark it for destruction. Antibodies remain in the body even after the virus is destroyed. This means that, after the viral attack, the body has a “standing army” of antibodies ready to respond to the next attack.

Vaccines work by simulating a viral attack without actually causing one. This causes the body to create an army of antibodies even though there is no virus. Then, when the real virus appears, the body is prepared to eliminate the infection.

Is Gardasil Safe?

Each Gardasil shot contains ingredients in addition to the viral component (called adjuvants) that are capable of causing adverse reactions in their own right. They include:

• Amorphous aluminum hydroxyphosphate sulfate (AAHS)
• Polysorbate 80
• Sodium borate (borax)
• L-histidine
• Genetically modified yeast protein
• Undisclosed HPV DNA fragments

Adjuvants provoke immune system responses and increase the permeability of blood vessels. While some of the adjuvants are substances that appear in nature, it is important to keep in mind that these substances are being injected into the bloodstream, not simply being ingested or coming into contact with the skin, thus the potential for harm is intensified.

Is Gardasil Effective?

Evidence that Gardasil prevents cancer is remarkably weak. The target age for inoculation is between 11 to 12 years old, but the median age of death by cervical cancer is 58 in the US and the cervical cancer death rate is 2.3 per 100,000. It takes 15 to 30 years for infection with HPV to lead to cancer. With such a low death rate and the decades it takes for cancer to develop, it would take an impossibly large population of patients to reach any statistically significant result in a study to show whether Gardasil prevents cancer.

• Cervical cancer causes 1 death in 43,500 Americans.
• Median age of cervical cancer diagnosis: 50

[National Cancer Institute data]

Merck tested Gardasil against the development of lesions known as CIN2 and CIN3. CIN stands for “cervical intraepithelial neoplasia,” an abnormal growth of cells on the surface of the cervix. Only a small fraction of these lesions ever progress to cancer.

The authors of a 2008 study published in Lancet Oncology estimated that, for women who received adequate treatment, including treatment for recurrent disease, the 30-year risk of cervical cancer in women diagnosed with CIN3 was 0.7%. In other words, in 30 years, 7 out of 1,000 women with CIN3 would get cervical cancer.

Researchers at the National Institute for Public Health and the Environment in the Netherlands estimated that the median time from CIN2/3 to cervical cancer was 23.5 years, with only 1.6% of lesions progressing to cancer within the first 10 years. According to the Cleveland Clinic, treatment of CIN2 and CIN3 lesions is 90% successful and reduces the risk of cervical cancer by 95% for 8 years.) In short, with proper screening, cervical cancer is almost entirely preventable.

Can Gardasil Cause Cancer?