Gardasil HPV Vaccine Description

Merck's Gardasil vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water.

The U.S. FDA initially approved Gardasil for use in the USA on June 8, 2006, and a final approval letter was issued on April 24, 2015. 

It is approved for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11.  CDC's Advisory Committee on Immunization Practices (ACIP) recommended a routine 3-dose vaccination series for girls 11 and 12.  The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or have not received all 3 doses.

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA.  Approximately half of the study participants received the vaccine, and the other half received a control.  These studies showed that in women who have never been infected by HPV types 6, 11, 16, or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina, and vulva and in preventing genital warts caused by these HPV types.

The Gardasil vaccine is an important cervical cancer prevention tool that will potentially benefit millions of women's health.  Every year, about 12,000 women are diagnosed with cervical cancer, and almost 4,000 die from this disease in the United States.  Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

Gardasil is endorsed by the WHO, which says HPV vaccines prevent cervical cancer by preventing infection by various HPV types.

Merck & Co., Inc. is an American multinational pharmaceutical company and one of the world's largest pharmaceutical companies. Merck is incorporated in New Jersey.

Gardasil HPV Vaccine Indication

Gardasil is a vaccine indicated in girls and women 9 through 26 years of age to prevent the following diseases caused by 4 Human Papillomavirus (HPV) types included in the vaccine.

Based on the FDA and CDC's review of available information, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. The CDC has not changed its recommendations for the use of Gardasil.  FDA has not made any changes to the prescribing information for how the vaccine is used. 

Gardasil HPV Vaccine Dosage

Gardasil should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months.

Gardasil is not available in the USA. Gardasil 9 is the featured HPV vaccine in the USA.

Gardasil HPV Vaccine Clinical Trials

Gardasil's review was associated with the following National Clinical Trial number(s): NCT00092534, NCT00092547, NCT00090220, and NCT00090285.