Merck Issues Statement on GARDASIL® Litigation
January 28, 2025 8:55 am ET
RAHWAY, N.J., Jan. 28, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today reaffirmed its commitment to defending the safety and efficacy of its HPV vaccines.
Merck is a defendant in product liability lawsuits in the United States involving GARDASIL® (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant).
In response to the trial, which began jury selection on January 22 in California, Merck issued the following statement:
“At Merck, the safety of our medicines and vaccines and the wellbeing of the people who take them are our top priority. An overwhelming body of scientific evidence, including more than 30 years of research and development along with real world evidence generated by Merck and by independent investigators, continues to support the safety and efficacy profiles of our HPV vaccines. The plaintiff’s allegations have no merit, and we remain committed to vigorously defending against these claims in the upcoming trial.”
For more information about GARDASIL and GARDASIL 9, visit www.gardasil9facts.com.
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 GARDASIL 9 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.
Indication – Limitations of Use
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 for a 2-dose regimen of GARDASIL 9 is unknown.
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.
- For GARDASIL, complete vaccination regimen for individuals aged 9 through 26 years of age consists of 3 doses at the following schedule: 0, 2 months, 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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
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, 2023 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 [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.
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.
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