Gardasil 9® HPV Vaccine Clinical Trials, Dosage, Indication, Side Effects, Usage
Merck's GARDASIL 9® vaccine protects people ages 9 to 45 against the following diseases caused by nine types of human papillomavirus (HPV): cervical, vaginal, and vulvar cancers in females, anal cancer, specific head and neck cancers, and genital warts in both males and females. The Gardasil 9 vaccine consists of HPV proteins, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, Polysorbate 80, sodium borate, and water for injection.
In 2021, the U.S. Food and Drug Administration (FDA) approved an expanded indication to include oropharyngeal and other head and neck cancers caused by HPV. On April 11, 2022, Health Canada approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age for the prevention of infection caused by HPV and the following diseases associated with the HPV types included in the vaccine: Oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Additionally, the U.S. Centers for Disease Control and Prevention (CDC) says that men can get HPV, causing anal and throat cancers and genital warts.
In addition, the CDC's vaccine committee reviewed an updated presentation on June 22, 2022, on HPV vaccination coverage and the impact of the U.S. HPV vaccination program. GARDASIL 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 does not prevent all types of cervical, vulvar, vaginal, anal, or head and neck cancers. A study published on May 31, 2023, concluded there is strong evidence for high VE against anal HPV infection and AIN in HIV-negative individuals vaccinated at age ≤26 years.
On September 5, 2023, Merck announced that data showed sustained HPV antibody responses ten years after the third dose in boys and girls. Across GARDASIL 9-targeted HPV types, antibody assessments evaluated through geometric mean titers peaked at Month 7 and decreased after 126 months. The vast majority of study participants remained seropositive at the end of the study period; 99.6% to 100% of study participants were seropositive for the targeted HPV types at Month 7 based on HPV-9 competitive Luminex® immunoassay, and 81.3% to 97.7% remained seropositive at Month 126 depending on the HPV type. Based on the HPV-9 immunoglobulin G Luminex immunoassay, 94.9% to 100% of participants were seropositive at Month 126.
In its presentation at the JPM 2023 Conference on January 10, 2023, Merck indicated that sales of HPV vaccines are expected to double by 2030. Merck announced on April 25, 2024, that Gardasil 9 realized $2.25 billion in sales, a 14% growth in Q124 compared to the prior year period. According to UNICEF, around 125 countries offer HPV vaccines in 2024.
On March 13, 2024, the company announced plans to conduct clinical trials in females and males to evaluate the efficacy and safety of the World Health Organization-endorsed single-dose HPV regimen compared to the approved GARDASIL®9 three-dose regimen. Additionally, Merck announced plans to initiate clinical development of an investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types.
Merck Sharp & Dohme Corp., Merck & Co., Inc.'s subsidiary, produces Gardasil 9 vaccines.
Gardasil 9 Indication
Gardasil 9 helps protect women ages 9 to 45 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by nine types of HPV.
Gardasil 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. In Japan, administration of a 3-dose regimen of GARDASIL 9 in young men reduced the combined incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo.
The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on its effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Most sexually active persons become infected with HPV at least once. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 100 types of HPV have been identified, 40 of which can infect the genital area. Most HPV infections are self-limited and are asymptomatic or unrecognized. However, many females with cervical cancers were probably exposed to cancer-causing HPV types in their teens and early 20s.
Gardasil 9 Dosage - U.S.
The U.S. CDC now recommends that 11 to 12-year-olds get two doses of the HPV vaccine—rather than the previously recommended three doses—to protect against cancers caused by HPV. The second dose should be given 6-12 months after the first dose. Each dose of Gardasil 9 is 0.5-mL and is administered intramuscularly only. The Age Recommended Regimen Schedule: 9 through 14 years - 2 doses at 0, 6 to 12 months; 15 through 45 years - 3 doses at 0, 2, and 6 months.
Gardasil 9 Dosage - U.K.
The move to the 9-valent vaccine is due to commence in 2022. The 9-valent HPV vaccine is JCVI's preferred vaccine for the routine adolescent program because of the additional protection against the five cancer-causing HPV types. On August 5, 2022, the UK's JCVI endorsed a one-dose HPV 9 regimen.
Gardasil 9 and HIV
A peer-reviewed study published on October 1, 2022: Prevalence and Risk Factors of Anal HPV Infection in MSM Living With HIV: Identifying the Target Groups to Prioritize for Immunization, concluded that MSM with HIV would benefit from Gardasil 9 immunization.
Gardasil 9 Adverse Events
Anyone who is allergic to the ingredients of Gardasil 9, including those severely allergic to yeast, should not receive the vaccine. Gardasil 9 was not studied in women who knew they were pregnant. On April 5, 2021, the JAMA published a study, 'Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes.' In this cohort study of 1,493 pregnancies, in adjusted analyses, during-pregnancy or peripregnancy exposures to the 9vHPV vaccine were not associated with spontaneous abortion. In addition, 9vHPV vaccine exposures during or around pregnancy were not associated with adverse birth outcomes among live births.
Gardasil 9 Side Effects
Gardasil 9 side effects include pain, swelling, redness, itching, bruising, bleeding, a lump where your child got the shot, headache, fever, nausea, and dizziness. Fainting can happen after getting Gardasil 9. Sometimes, people who faint can fall and hurt themselves. For this reason, healthcare professionals may ask your child to sit or lie down for 15 minutes after your child gets Gardasil 9. Some people who faint might shake or become stiff.
Gardasil Litigation 2023
As of May 15, 2023, 86 legal cases have been filed and transferred to the MDL and remain open. On March 20, 2023, Judge Conrad granted the plaintiffs' motion to compel Merck to provide plaintiffs' attorneys with access to its entire database of adverse reactions to the HPV vaccine, including the Merck Adverse Event Reporting and Review System.
Gardasil 9 Price
The list price for each indicated dose of GARDASIL 9 is $252.85. However, most people will not pay the list price, says Merck. The U.S. CDC Vaccine Price List was last updated in 2024. Vaccine price discount information is posted at InstantRx™.
Gardasil 9 Vaccine News
September 11, 2024 - "A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
March 13, 2024 - "Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health," said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories.
October 27, 2022—Merck confirmed China's National Medical Products Administration approval in September 2022 to expand GARDASIL 9 to girls and women ages 9 to 45. The vaccine was previously approved for use in women ages 16 to 26.
April 11, 2022 - The WHO announced that the one-dose HPV vaccine protects against cervical cancer.
November 29, 2021—The JAMA Pediatrics published a Research Letter titled "Human Papillomavirus Vaccination and Trends in Cervical Cancer Incidence and Mortality in the US." The letter found a 38% decrease in cervical cancer incidence and a 43% decline in mortality among women after HPV vaccination.
March 11, 2021 - PLOS published a cost-effectiveness analysis using the Cancer Intervention and Surveillance Modeling Network models to evaluate the cost-effectiveness of extending HPV vaccination to females and males up to 30, 35, 40, or 45 years. This study found that HPV vaccination of women and men aged 30 to 45 provides limited health benefits at the population level at a substantial cost (HPV vaccine prices).
February 1, 2021 - U.S. C.D.C. published research: Volume 27, Number 3—March 2021: Oral Human Papillomavirus Infection in Children during the First 6 Years of Life, Finland. Children acquire their first oral HPV infection at an early age. The mother's HPV status has a significant impact on the outcome of oral HPV persistence for her offspring.
October 5, 2018 - F.D.A. approved your request dated April 6, 2018, to supplement your Biologics License Application (B.L.A.) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL® 9) to extend the age range for the use of the vaccine to include women and men from 27 to 45 years of age.
February 9, 2018 - F.D.A. approved your request dated August 11, 2017, to supplement your Biologics License Application (B.L.A.) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9®), to revise Sections 2.3 and 14.4 of the Gardasil 9® package insert to clarify information regarding the study conducted to assess the safety and immunogenicity of Gardasil 9® in individuals who were previously vaccinated with Gardasil®.
December 16, 2016 - The CDC report includes new recommendations for using a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9 through 14. Three doses remain recommended for immunocompromised persons and persons who start the vaccination series at ages 15 through 26.
Gardasil®9 HPV Vaccine Clinical Trials
Phase 4 study—NCT03943875—Sponsor: The University of Texas Medical Branch, Galveston; Collaborator: Cancer Prevention Research Institute of Texas. We evaluate whether 15-26-year-old males and females need a third dose of the HPV vaccine or whether two doses provide similar protection as three doses from the nine types of HPV it protects against. The estimated Primary Completion Date is February 28, 2022.
