Merck Canada Statement on Dosing Recommendations for GARDASIL®9
KIRKLAND, QC., July 11, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, affirms its position regarding dosing regimens for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain HPV-related cancers and diseases.
HPV vaccination has an established legacy of substantial public health impact using the currently licensed regimens, including documented reductions in certain HPV-related cervical cancers at a population level.
Merck Canada maintains that until there are sufficient data to enable Health Canada, the U.S. Food and Drug Administration (FDA) and European Commission to license an alternate dosing regimen for GARDASIL®9, the recommendation should remain consistent with the approved product labeling.
The 2- and 3-dose regimens currently described in the approved product labeling were evaluated in large clinical studies that met regulatory agency standards and were extensively evaluated through the regulatory approval process. Health Canada approved *GARDASIL® in 2006 and GARDASIL®9 in 2015. These vaccines respectively have over 19 years and 10 years of real-world experience.
Merck has announced plans to conduct two large clinical trials of single dose regimens of its 9-valent HPV vaccine, GARDASIL®9, in males and females 16-26 years. As is routinely done prior to starting clinical trials, Merck sought guidance from the FDA and European Medicines Agency (EMA) regarding its proposed single dose trial designs to ensure they would serve as an acceptable basis for a future change to the approved dosing regimens in the label. During these discussions, the FDA was clear about the high standard of evidence that would be required for the licensure of single-dose regimens. Specifically, the FDA’s feedback included the need for:
- Comparable effectiveness data of a single-dose regimen to the approved three-dose regimen;
- Demonstration that single dose efficacy is not reduced for HPV disease endpoints beyond cervical persistent infection; and
- Efficacy in men, noting there are currently no data supporting the efficacy of single-dose regimens in men.
This feedback from the FDA was highlighted in a letter shared with the CDC’s Advisory Committee on Immunization Practices (ACIP). Additional details regarding FDA comments to Merck’s two clinical trials to evaluate the potential for inclusion of a single dose regimen in the label of GARDASIL®9 can be found here.
In addition, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has indicated the need for data in males, stringent non-inferiority margins, data for all Gardasil®9 HPV types, and long-term durability data.
Indication for GARDASIL®9 in Canada
GARDASIL®9, is a vaccine indicated for:
- Individuals 9 through 45 years of age for the prevention of infection caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 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
GARDASIL®9 has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for GARDASIL®9 please refer to Health Canada’s Notice of Compliance with conditions – drug products web site: Notice of Compliance with conditions (NOC/c) – Canada.ca
GARDASIL®9, is a vaccine indicated for:
- Individuals 9 through 45 years of age for the prevention of infection caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 and the following diseases associated with the HPV types included in the vaccine:
- Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11 and the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical adenocarcinoma in situ (AIS)
- Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
- Cervical intraepithelial neoplasia (CIN) grade 1
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
GARDASIL®9 has been issued market authorization without conditions. For more information regarding the indication for GARDASIL®9, please refer to the product monograph.
Dosing and Administration
Recommended Dose and Dosage Adjustment
GARDASIL®9 should be administered intramuscularly as 3 separate 0.5 mL doses according to the following schedule:
First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose
Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1 year period.
Alternatively, in individuals 9 through 14 years of age, GARDASIL®9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
The use of GARDASIL®9 should be in accordance with official recommendations.
General information for GARDASIL®9
As for any vaccine, vaccination with GARDASIL®9 may not result in protection in all vaccine recipients.
This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN, VIN, VaIN, or AIN.
This vaccine will not protect against diseases that are not caused by HPV. GARDASIL®9 has not been shown to protect against diseases due to HPV types not contained in the vaccine.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after HPV vaccination. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL®9.
Routine monitoring and Pap test in women should continue to be performed as indicated, regardless of GARDASIL®9 administration. Recipients of GARDASIL®9 should not discontinue screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers if it has been recommended by a health professional. Appropriate precautions against sexually transmitted diseases should continue to be used.
Headache, fever, nausea, dizziness, fatigue, diarrhea, oropharyngeal pain, upper abdominal pain, and local injection site reactions (pain, swelling, erythema, pruritus, bruising, hematoma, mass, hemorrhage, induration) occurred after administration with GARDASIL®9.
GARDASIL®9 is contraindicated in patients who are hypersensitive to either *GARDASIL® or GARDASIL®9 or component of the container. GARDASIL®9 is also contraindicated in individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL®9 or *GARDASIL® should not receive further doses of GARDASIL®9.
There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. As a precautionary measure, the administration of GARDASIL®9 during pregnancy should be avoided. Women who become or plan to become pregnant during the vaccination series should be advised to interrupt or postpone the vaccination regimen until completion of pregnancy.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.
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*Please note that GARDASIL® is no longer marketed in Canada, the U.S. or the European Union