Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9
Company reaffirms commitment to reduce the global burden of HPV-related diseases, including certain cancers
“Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health,” said Dr.
In the
Multivalent HPV vaccine research
Assessing the potential efficacy and durability of a single dose regimen of GARDASIL 9
In response to calls from scientific leaders for more clinical data concerning alternative dosing regimens for GARDASIL 9,
HPV vaccine supply
To address the increasing global demand for GARDASIL and GARDASIL 9 and support broader and equitable access,
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 (
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:
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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.
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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 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
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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