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May 23, 2025 8:00 am ET

RAHWAY, N.J., May 23, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today affirmed its position regarding alternate 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.

GARDASIL 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and 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. GARDASIL 9 is also indicated for use 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. The oropharyngeal and head and neck cancer indication is 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. The confirmatory trial is ongoing. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Merck maintains that until there are sufficient data to enable the U.S. Food and Drug Administration (FDA) and European Commission to license an alternate dosing regimen for GARDASIL 9, the Centers for Disease Control and Prevention (CDC) recommendation should remain consistent with the approved product labeling. The 2- and 3-dose regimens currently described in the U.S. and European Union product labeling were evaluated in large clinical studies that met regulatory agency standards and were extensively evaluated through the regulatory approval process. The FDA approved GARDASIL in 2006 and GARDASIL 9 in 2014. The vaccines have over 18-years and 10-years of real-world experience respectively.

As is routinely done prior to starting clinical trials, Merck sought guidance from the FDA 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.

GARDASIL, Merck’s four-valent HPV Vaccine, is not marketed in the United States.

Indication for GARDASIL and GARDASIL 9

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age. GARDASIL is a vaccine indicated in females 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age. GARDASIL is indicated in males 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is 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.

GARDASIL 9 and GARDASIL do not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 and GARDASIL have not been demonstrated to provide protection against diseases caused by:

• HPV types not covered by the vaccine
• HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 and GARDASIL protect only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types contained in the vaccines.

GARDASIL 9 and GARDASIL are not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 or GARDASIL may not result in protection in all vaccine recipients.

Select Safety Information

GARDASIL 9 and GARDASIL are contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

Safety and effectiveness of GARDASIL 9 and GARDASIL have not been established in pregnant women.

For GARDASIL 9, the most common (=10%) local and systemic adverse reactions in females were: injection-site pain, swelling, erythema, and headache. The most common (=10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. For GARDASIL, the most common (=1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.

The duration of immunity of GARDASIL and a 2-dose schedule of GARDASIL 9 has not been established.

Dosage and Administration

Administer either GARDASIL 9 or GARDASIL intramuscularly in the deltoid or anterolateral area of the thigh.

For GARDASIL 9, a complete vaccination regimen consists of:

• For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2- dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
• For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3- dose schedule at 0, 2 months, and 6 months.

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, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

About Merck’s global commitment to supply and access to HPV vaccines

Merck is committed to working to ensure adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases.

To realize this commitment, Merck has made significant capital investments, including more than $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand. As a result, we expect to supply sufficient quantities of our HPV vaccines to meet anticipated demand and will continue to expand supply capacity in the future.

Globally, we are supplying our HPV vaccines to over 150 National Immunization Programs and we continue to support program expansions.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This statement of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf

Please see Prescribing Information for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information/Medication Guide for GARDASIL at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.

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