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. Gardasil 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.

The U.S. 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 who have not yet been vaccinated or received all three doses.

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.

Gardasil is endorsed by the WHO, which says HPV vaccines prevent cervical cancer by preventing infection by various HPV types. Unfortunately, Gardasil is not available in the USA. Gardasil 9 is the featured HPV vaccine in the USA.

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

Gardasil HPV Vaccine Indication

Gardasil is a vaccine indicated to prevent diseases caused by 4 HPV types included in the vaccine. HPV vaccination is recommended for all preteens (including girls and boys) at age 11–12 years. All preteens need HPV vaccination to protect them from HPV infections that can cause cancer later in life.

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

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. Therefore, the CDC has not changed its recommendations for the use of Gardasil. Likewise, the FDA has not changed 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, six months.

Gardasil HPV Vaccine Side Effects

People rarely have a more severe allergic reaction, called an anaphylactic reaction, immediately after HPV vaccination.

Gardasil HPV Vaccine News

December 16, 2021 - GAVI reported in Kenya, Africa, HPV is the second cause of cancer among women between 15 and 44 years, with approximately 5,250 cases diagnosed yearly. In October 2019, Kenya announced plans to have more than 800,000 girls protected against cervical cancer through the introduction of the HPV vaccine.

November 12, 2021 - The Lancet published a study funded by Merck: Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomized, placebo-controlled, phase 3 trial. Study Interpretation - The quadrivalent HPV vaccine provides durable protection against anogenital disease related to HPV6, 11, 16, and 18. The results support quadrivalent HPV vaccination in men, including catch-up vaccination.

October 8, 2021 - A cohort phase 4 study in India compared the HPV vaccine efficacy of single-dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at ten years post-vaccination. Vaccine efficacy against persistent HPV 16 and 18 infections among participants evaluable for the endpoint was 95·4% (95% CI 85·0–99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3–99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5–99·7) in three-dose recipients (1460 women considered).

September 17, 2021 - Original Research: Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States, was published by the JAMA Network. Safety concern has been identified as a primary barrier to initiating the human papillomavirus (HPV) vaccine in the US. However, it is unclear if the public's sentiment concerning HPV vaccine safety aligns with postmarketing vaccine safety surveillance data. Conclusions and Relevance  In this descriptive cross-sectional study, a rise in citing safety concerns were observed among parents with HPV vaccine hesitancy, contrary to the severe and nonserious AE reporting trends. These findings suggest an urgent need to combat the rising sentiment of safety concerns among caregivers to increase HPV vaccine confidence.

August 31, 2021 - Fierce Pharma reported Merck's HPV vaccine Gardasil 9, which saw an 11% annual price hike, according to the Bernstein analysts. Gardasil 9 and its sister shot Gardasil were hit particularly hard during the pandemic as patients delayed doctor visits and prioritized COVID-19 jabs. However, those vaccines have started their comeback as sales jumped 88% during the second quarter to $1.23 billion.

August 28, 2021 - The Lancet published a study that found 'Reassuringly, our large well-controlled study does not support that human papillomavirus vaccination increases the risk of non-targeted infectious disease in any clinically meaningful way. While our study does not provide evidence against adverse effects of other non-live vaccines, it does provide evidence against the claim that all non-live vaccines increase the risk of heterologous infections in females.'

August 8, 2021 - Thailand confirmed that all lots of HPV vaccines registered had been certified by the Institute of Biological Products, Department of Medical Sciences.

Gardasil HPV Vaccine Clinical Trials

Gardasil has been tested in over 195 clinical trials, studying the vaccine's safety, effectiveness, and immunogenicity.

ClinicalTrials.gov Identifier: NCT00923702 - Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010, and followed up over a median duration of 9 years. 4,348 participants had three doses, 4,980 had two doses (0 and 6 months), and 4,949 had a single dose. Interpretation: A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses.