Vaccine Info

Gardasil 9 HPV Vaccine

Gardasil 9 HPV Vaccine Description

Gardasil 9 consists of human papillomavirus (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.

Approximately 100 types of HPV have been identified, at least 40 of which can infect the genital area, says the US CDC.

HPV infections can lead to certain cervical cancers. Many females with cervical cancer were probably exposed to cancer-causing HPV types in their teens and early 20s. Unlike some other cancers, cervical cancer is not thought to be passed down through family genes.

Additionally, males can get HPV, causing anal and throat cancers, and genital warts, says the CDC.

Most HPV infections are self-limited and are asymptomatic or unrecognized. Most sexually active persons become infected with HPV at least once in their lifetime.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., produces the Gardasil 9 vaccine.

Gardasil 9 HPV Vaccine Indication

Gardasil 9 helps protect girls and women ages 9 to 45 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV. It also is indicated to help protect boys and men ages 9 to 45 against anal cancer and genital warts caused by those same HPV types.

The U.S. FDA approved an expanded indication for GARDASIL 9 for the prevention of oropharyngeal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication are approved under accelerated approval based on 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 which is currently underway.

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

Gardasil 9 HPV Vaccine Dosage

The CDC now recommends 11 to 12-year-olds get 2-doses of HPV vaccine—rather than the previously recommended 3-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-dose 0, 6 to 12 months 
  • 15 through 45 years 3-dose 0, 2, 6 months

Gardasil 9 HPV Vaccine Adverse Events

Anyone who is allergic to the ingredients of Gardasil 9 including those severely allergic to yeast, should not receive the vaccine. And GARDASIL 9 was not studied in women who knew they were pregnant.

Gardasil 9 HPV Vaccine Side Effects

Gardasil 9 side effects include pain, swelling, redness, itching, bruising, bleeding, and 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, your health care professional 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 9 HPV Vaccine News

October 27, 2020 -  Merck EVP and chief commercial officer Frank Clyburn said during the new earnings call that Gardasil sales fell by 10% in Q3'2020, largely due to lower demand in the U.S. and Hong Kong, SAR, PRC attributable to the COVID-19 pandemic, partially offset by higher volumes in China and in Europe.

August 27, 2020 - Health Canada announced the extension of the indication for Gardasil 9 to include men between the ages of 27 and 45.

June 12, 2020 - Merck announced that the U.S. FDA has approved an expanded indication for GARDASIL9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

May 28, 2020 - Prophylactic, quadrivalent HPV vaccination can prevent genital warts in healthy women and men, therefore, it should be included in the routine immunization programs.

April 18, 2020 – During 2007–2016, the incidence of cancers of the oral cavity and pharynx increased, despite decreases in several anatomic sites, including the nasopharynx, hypopharynx, lip, and the floor of the mouth.

February 12, 2020 – New cancer prevention research published by researchers at The University of Texas Medical Branch (UTMB) at Galveston indicates that just 1-dose of a human papillomavirus (HPV) vaccine is as effective as multiple vaccinations for preventing pre-invasive cervical disease.

May 31, 2019:  A new study published in Science Direct, reported that within 10  years of HPV vaccine introduction, the vaccine-type HPV (VT) prevalence decreased 78 percent among 20 to 24-year-old women, and 38 percent in 25 to 29-year-old women.

October 5, 2018 - FDA approved your request dated April 6, 2018, to supplement your Biologics License Application (BLA) 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 - FDA approved your request dated August 11, 2017, to supplement your Biologics License Application (BLA) 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 - This CDC report includes new recommendations for use of a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9 through 14 years. Three doses remain recommended for persons who initiate the vaccination series at ages 15 through 26 years and for immunocompromised persons.

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 are evaluating whether 15-26-year-old males and females need a 3rd dose of the HPV vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against. Estimated Primary Completion Date: February 28, 2022. 

Updated
10/28/2020 - 04:53