Gardasil 9® HPV Vaccine Description For 2022
Merck's GARDASIL 9® vaccine helps protect 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, certain head and neck cancers, and genital warts in both males and females. Gardasil 9 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.
Most sexually active persons become infected with HPV at least once in their lifetime. According to the U.S. 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. This is because cervical cancer is not passed down through family genes, unlike other cancers.
Additionally, the U.S. CDC says that men can get HPV, causing anal and throat cancers and genital warts. And 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.
In addition, the CDC's ACIP 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
Merck Sharp & Dohme Corp., a Merck & Co., Inc. subsidiary, produces the Gardasil 9 vaccine.
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 July 2022.
Vaccine price discount information is posted at InstantRx™.
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. It is also indicated to help protect boys and men ages 9 to 45 against anal cancer and genital warts caused by HPV types. In addition, the U.S. FDA approved an expanded indication for GARDASIL 9 to prevent 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. However, continued support for this indication may be contingent upon verification and clinical benefit description in a confirmatory trial, which is currently underway.
Gardasil 9® Dosage - U.S.
The U.S. CDC now recommends that 11 to 12-year-olds get 2-doses of the 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-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® 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. 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 9® Revenues For 2021
Merck & Co. announced on October 27, 2022, GARDASIL/GARDASIL 9 Sales Grew 15% to $2.3 Billion; Excluding the Impact From Foreign Exchange, Sales Grew 20%.
Gardasil 9® News For 2016 - 2022
October 27, 2022 - Merck confirmed China’s National Medical Products Administration approval in September 2022 to expand the use of GARDASIL 9 for use in girls and women ages 9 to 45. The vaccine was previously approved for use in women ages 16 to 26.
October 10, 2022 - Fortune's 2022 Change the World List has selected Merck for its work expanding global access to the company’s HPV vaccines.
May 17, 2022 - Original Research was published: Human Papillomavirus Vaccine Impact and Effectiveness Through 12 Years After Vaccine Introduction in the United States, 2003 to 2018. And a related Editorial: Long-Term Effectiveness of Human Papillomavirus Vaccination: Implications for Future Reduction in Cancer.
April 28, 2022 - Merck announced the company expanded its HPV vaccines manufacturing facility located in Elkton, VA, completing the construction of a 120,000 square foot extension and adding 150 new jobs at the site to increase the capacity and global supply of the company's HPV vaccines.
April 11, 2022 - The WHO announced one-dose HPV vaccine offers solid protection against cervical cancer.
April 11, 2022 - According to the Public Health Agency of Canada, about 25% to 35% of mouth and throat cancers are related to oral HPV infection.
April 4, 2022 - Merck confirmed it expects the supply of its HPV vaccines to double between 2020 and 2023 as the company expands capacity at existing facilities and new facilities come online.
March 30, 2022 - The BMJ published the findings from an Observational Study in Australia: Conclusions: Colposcopy referral thresholds need to consider underlying cancer risk; on this basis, women with HPV16/18 in the first round of HPV screening were found to be at higher risk regardless of cytology result, even in a previously well-screened population. Women with HPV types, not 16/18, and negative or low-grade cytology showed a low risk of serious abnormalities but constitute most referrals and could be managed safely with two rounds of repeat HPV testing rather than one. HPV16/18 driven referrals were low in HPV vaccinated cohorts.
March 16, 2022 - The JAMA Network published an Original Investigation that suggests the decrease in the incidence of cervical cancers, particularly in young women, may be associated with HPV vaccinations. However, it may be too early to evaluate this association in oropharyngeal and anal cancers later in life.
March 16, 2022 - NPJ published: Precision drugging of the MAPK pathway in head and neck cancer. About one-fifth of often deadly head and neck cancers harbor genetic mutations in a pathway that is key to normal cell growth. Scientists report those mutations, which enable abnormal cell growth, can also make cancer vulnerable.
February 10, 2022 - The JCVI committee presented to the U.K. government its recommendation to move to the 9-valent vaccine. This vaccine will protect against five additional cancer-causing HPV types.
January 1, 2022 - A new study found 'Opportunistically-detected high-grade vulvar and vaginal precancers among females aged 15–29 years decreased and anal precancers stabilized in years after introducing the HPV vaccine, which is suggestive of the impact of the vaccine on noncervical human papillomavirus cancers.'
November 29, 2021 - The JAMA Pediatrics published a Research Letter: Human Papillomavirus Vaccination and Trends in Cervical Cancer Incidence and Mortality in the US, which found a 38% decrease in cervical cancer incidence and a 43% decline in mortality among women after HPV vaccination.
September 29, 2021 - ANI reported M.S.D. Pharmaceuticals launched the Gardasil 9 HPV vaccine in India.
September 16, 2021 - A new study based in Italy concluded by saying, 'The prevalence of CIN3 lesions related to HPV 16/18 genotypes decreased over time from 2007 to 2018. These data highlight a herd effect of the HPV vaccine. However, fifteen years after the HPV vaccine introduction, we are still a long way from herd immunity. The increase in high-risk types 31/33/45/52/58 will need to be reassessed when the nonavalent vaccine impact will be more reliable.
September 15, 2021 - Local media in Ireland reported the Assistant Director of Nursing at the Marie Keating Foundation had urged all eligible First Year students to get the HPV vaccine.
September 2, 2021 - The JAMA Network published a population-based age-period-cohort analysis regarding future oropharynx cancer (O.P.C.) incidence concluded by stating, 'These findings forecast a continued shift in the landscape of O.P.C. to an older population. The results of this study suggest that the association of current HPV vaccination trends with O.P.C. will be modest during the next 25 years because of the reduction in O.P.C. incidence associated with HPV vaccination among older adults, who have the highest incidence of disease, will take longer.'
August 26, 2021 - The JAMA Network published an Original Investigation: Association Between Human Papillomavirus Vaccination and Primary Ovarian Insufficiency in a Nationwide Cohort. This study found no association between HPV vaccination and primary ovarian insufficiency. However, given the rarity of the outcome in this study, the presence of a clinically relevant increase in the rate of diagnosis cannot be excluded.
August 23, 2021 - The JAMA Network published an Original Investigation: Incidence and Types of Human Papillomavirus Infections in Adolescent Girls and Young Women Immunized With the Human Papillomavirus Vaccine. Conclusions and Relevance: Whereas lower detection rates of vaccine-related HPV types were observed since the introduction of vaccines in female youth in New York City, rates of some nonvaccine high-risk HPV types were higher. Continued monitoring of high-risk HPV prevalence is warranted.
July 28, 2021 - The U.K. government issued an update on the universal HPV immunization program. A recent Scottish study has already shown a 71% reduction in pre-cancerous cervical disease in young women. In addition, ten years since the start of the vaccination program in the U.K., there has been a considerable decline in HPV infections and the number of young people with genital warts.
July 29, 2021 - Merck announced growth in vaccines for the second quarter was primarily driven by higher combined sales of GARDASIL and GARDASIL 9. Second-quarter 2021 GARDASIL/GARDASIL 9 sales rebounded to $1.2 billion, growing 88%, primarily due to the ongoing COVID-19 pandemic recovery and underlying solid demand in the United States, as well as continued market uptake in specific ex-U.S. markets, including China, which also benefitted from increased supply.
June 28, 2021 - JAMA Pediatrics published a study that suggests safety concerns or adverse effects as the main reason for refusing HPV vaccination has increased over the years.
June 10, 2021 - William Calo from the College of Medicine's Department of Public Health Sciences and Penn State Cancer Institute side in a press release, "Our study is among the first to identify which combination of messaging elements from tweets is most effective to motivate parents to get their children vaccinated against HPV." According to the researcher's findings, parents trusted tweets from an organization more than those posted by a person. In addition, messages highlighting the vaccines' effectiveness spurred higher motivational responses for HPV vaccination than messages focused on safety.
May 25, 2021 - A new study led by Monash University and Alfred Health found a 70% reduction in one type of human papillomavirus (HPV) in gay and bisexual men after implementing an HPV vaccination program in 2013. A reduction in anal, penile, and oral quadrivalent vaccine-targeted genotypes occurred in young M.S.M. after implementing a school-based gender-neutral HPV vaccination program.
May 3, 2021 - Vaccine co-administration concerns with COVID-19 vaccines.
April 29, 2021 - Merck confirmed Gardasil vaccine sales decreased 20% in one year.
April 27, 2021 - The JAMA published a new study: HPV Vaccination Among Young Adults in the U.S.
March 30, 2021 - According to the Irish Pharmacy Union, there has been a significant fall-off in the number of students receiving the HPV vaccination. Only 53.6% of Ireland students received a first dose of the HPV vaccine in 2020 compared to over 80% in 2019.
March 26, 2021 - The US Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report: Declines in Prevalence of Human Papillomavirus Vaccine-Type Infection Among Females after Introduction of Vaccine — the United States, 2003–2018. This report confirmed 'HPV vaccination is a critical prevention tool against HPV infection, anogenital warts, and HPV-attributable precancers and cancers. HPV vaccination is highly effective and is recommended routinely at age 11–12 and through age 26 for persons not already vaccinated.'
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 in females and males up to 30, 35, 40, or 45 years. This study found HPV vaccination of women and men aged 30 to 45 years provides limited health benefits at the population level, at a substantial cost (HPV vaccine prices).
February 9, 2021 - Research Brief published by the American Academy of Pediatrics reported 'Adolescents' receipt of the human papillomavirus (HPV) vaccine. The proportion of up-to-date adolescents has improved over time. However, in 2017–2018, 7.3 million vaccine-eligible U.S. adolescents were unvaccinated. Notably, despite a provider recommendation, the parents of 60.6% of unvaccinated adolescents had no intention to initiate the HPV vaccine series.
February 4, 2021 - Merck (NYSE:MRK) reported Q4 revenues: $12,514M (+5%). Key Product Sales include Gardasil/Gardasil 9: $998M (+44%); Proquad, M-M-R II and Varivax: $488M (+2%).
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 HPV status of the mother has a significant impact on the outcome of oral HPV persistence for her offspring.
January 12, 2021 - The report estimates that in the U.S., in 2021, almost 1.9 million (1,898,160) new cancer cases will be diagnosed, and 608,570 Americans will die from cancer. These projections are based on currently available incidence and mortality data through 2017 and 2018, respectively, and thus do not account for the impact of the COVID-19 pandemic on cancer diagnoses or deaths.
January 5, 2021 - The human papillomavirus infection, or HPV, is the most common sexually transmitted infection in the U.S., according to the Centers for Disease Control and Prevention. HPV is associated with health problems, including genital warts and cancers, but a vaccine has been available since 2006 to stop the virus. The C.D.C. reports more than 12 years of data to support the HPV vaccine is safe and effective, yet HPV vaccination rates across the U.S. remain low. Social media has a history of being a popular place for sexual health discussions, and the HPV vaccine is one of the most discussed vaccines on the internet. Monique Luisi, an assistant professor in the University of Missouri School of Journalism, has studied more than 6,500 public HPV vaccine-related posts on Facebook from 2006 to 2016.
December 25, 2020 - Washington D.C. - Minor Consent for Vaccinations Amendment Act of 2019. As introduced, this bill permits a minor of any age to consent to receive a vaccine where the vaccination is recommended by the C.D.C.'s Advisory Committee on Immunization Practices. It also establishes that informed consent is confirmed if a minor can comprehend the need for, the nature of, and any significant risks inherent in medical care.
December 6, 2020 - The Urban Public Health Network is joining forces with the University of Saskatchewan for a project that seeks to eliminate cervical cancer. The project is funded by the Canadian Partnership Against Cancer totaling $1.6 million. The goal is to eliminate cervical cancer in Canada by 2040. "Current immunization rates for HPV range from 57% to 92% in various provinces, and we need to reach above 90% across Canada, in all populations," said Neudorf.
November 17, 2020 - The WHO's Global Strategy to Accelerate the Elimination of Cervical Cancer outlines three key steps: vaccination, screening, and treatment to reduce more than 40% of new disease cases and 5 million related deaths by 2050.
November 16, 2020 - A.A.P. study: Cost-effectiveness of Interventions to Increase HPV Vaccine Uptake. Three interventions for increasing HPV vaccine coverage were cost-effective and offered substantial health benefits. Therefore, policymakers seeking to increase HPV vaccination should, at minimum, dedicate additional funding for Q.I. visits, which are consistently effective at low cost and may additionally consider more resource-intensive interventions (reminder and recall or school-located vaccination).
November 14, 2020 - College students from minority communities and communities of color are less likely to receive the human papillomavirus (HPV) vaccine compared with individuals in the White community, with Black women significantly less likely than Black men to plan to receive the vaccination, according to results from a small study presented at the Association of Nurses in AIDS Care Virtual Conference.
November 3, 2020 - A new analysis published in the British Journal of Clinical Pharmacology shows that HPV vaccines are safe and well-tolerated in the male population. The side effects that may occur after immunization are similar in both sexes. "To the best of our knowledge, this is one of the first studies focused on the evaluation of the safety profile of HPV vaccines in males," the authors wrote.
October 27, 2020 - Merck E.V.P. and chief commercial officer Frank Clyburn said during the recent earnings call that Gardasil sales fell by 10% in Q3'2020, largely due to lower demand in the U.S. and Hong Kong, S.A.R., P.R.C. attributable to the COVID-19 pandemic, partially offset by higher volumes in China and Europe.
October 8, 2020 - A new study led by Jeanine Guidry, Ph.D., compared how HPV vaccination was portrayed on Pinterest before and after the social media platform began moderating vaccine-related content. Findings may help public health officials utilize social media to tackle potentially harmful rhetoric and disseminate trustworthy health information. "Vaccine misinformation is immensely prevalent online and particularly on social media," said Guidry, who is also director of the Media+Health Lab at V.C.U. "Although the specific influence of social media on medical decision-making remains understudied, research supports an association between online health information searches and medical decisions."
October 2, 2020 - Area-Level Variation and Human Papillomavirus Vaccination among Adolescents and Young Adults in the United States: A Systematic Review. Results demonstrate the need to move beyond existing multilevel methods and adopt geospatial approaches to map and detect geographic areas with low HPV vaccination coverage.
September 16, 2020 - U.S. Pharmacist - Human Papillomavirus Vaccine Update.
September 3, 2020 - C.D.C. report: HPV-Associated Cancers Rates by Race and Ethnicity. This study used cancer registry data to estimate the amount of HPV-associated cancer in the United States by examining cancer in parts of the body and cancer cell types that are more likely to be caused by HPV.
August 27, 2020 - Health Canada announced the extension of Gardasil 9 to include men between the ages of 27 and 45.
June 12, 2020 - Merck announced that the U.S. F.D.A. had approved an expanded indication for GARDASIL9 to prevent oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. "Oropharyngeal cancer is the most common cancer caused by HPV in the U.S., and men are five times more likely to be diagnosed than women," said Dr. Alessandro Villa, Ph.D., chief of the Sol Silverman Oral Medicine Clinic at the University of California, San Francisco, and a consultant to the American Dental Association Council on Scientific Affairs who has worked with the A.D.A. on HPV and oral cancer initiatives. "Prophylactic HPV vaccination represents a safe and effective tool for the prevention of oropharyngeal cancers."
May 28, 2020 - Prophylactic, quadrivalent HPV vaccination can prevent genital warts in healthy women and men; therefore, it should be included in routine immunization programs.
April 18, 2020 – During 2007–2016, cancers of the oral cavity and pharynx increased, despite decreases in several anatomic sites, including the nasopharynx, hypopharynx, and lip 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 effective as multiple vaccinations for preventing pre-invasive cervical disease.
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 - This C.D.C. 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 persons who start the vaccination series at ages 15 through 26 and 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 evaluate 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.