Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the National Medical Products Administration (NMPA) of China approved GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, 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, and 18: grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN).

“The approval of GARDASIL for use in males 9-26 years old in China is a significant step forward in advancing public health,” said Joseph Romanelli, president, Human Health International, Merck. “Since first approval, our HPV vaccines have helped protect over 50 million females in China from certain HPV-related cancers and diseases. With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases.”

Indications for GARDASIL

GARDASIL is a vaccine indicated in females 9 through 45 years of age. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL is indicated in males 9 through 26 years of age. 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, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, and anal cancers as recommended by a health care provider.

GARDASIL has 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, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 6, 11, 16 and 18.

GARDASIL is 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 may not result in protection in all vaccine recipients.

Select Safety Information for GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of 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 have not been established in pregnant women. 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 has not been established.