Merck's Gardasil Approved in China for HPV Prevention in Males
Key Insights
China's NMPA has approved Gardasil for use in males aged 9-26, marking the first HPV (search) vaccine approved for males in China.
Gardasil is now indicated for the prevention of anal cancers (search), genital warts (search), and precancerous lesions caused by HPV (search) types 6, 11, 16, and 18 in Chinese males.
This approval expands the reach of Gardasil, which has already protected over 50 million females in China from HPV (search)-related diseases.
Merck (search)'s Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] has received approval from China's National Medical Products Administration (NMPA) for use in males aged 9-26 years. This approval marks a significant milestone as Gardasil becomes the first HPV (search) vaccine available for males in China, offering protection against certain HPV-related cancers and diseases.
The expanded indication includes the prevention of anal cancers (search) caused by HPV (search) Types 16 and 18, genital warts (search) (condyloma acuminata) caused by HPV Types 6 and 11, and precancerous or dysplastic lesions (grade 1, grade 2, and grade 3 anal intraepithelial neoplasia) caused by HPV Types 6, 11, 16, and 18.
Impact on Public Health
Joseph Romanelli, president of Human Health International at Merck (search), stated, "The approval of Gardasil for use in males 9-26 years old in China is a significant step forward in advancing public health." He further noted that Merck's HPV (search) vaccines have already helped protect over 50 million females in China. This expanded approval aims to extend that protection to a new population of Chinese males.
Gardasil's Indications and Limitations
Gardasil is indicated for females aged 9 through 45 years for the prevention of cervical, vulvar, vaginal, and anal cancers (search) caused by HPV (search) Types 16 and 18, precancerous lesions caused by HPV Types 6, 11, 16, and 18, and genital warts (search) caused by HPV Types 6 and 11. For males aged 9 through 26 years, it is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, precancerous lesions caused by HPV Types 6, 11, 16, and 18, and genital warts caused by HPV Types 6 and 11.
It is important to note that Gardasil does not eliminate the need for screening for cervical, vulvar, vaginal, and anal cancers (search). The vaccine does not protect against HPV (search) types not covered by the vaccine or HPV types to which a person has already been exposed. Gardasil is also not a treatment for existing HPV-related conditions or cancers.
Safety and Administration
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL. Observation for 15 minutes after administration is recommended due to the risk of syncope. The most common adverse reactions include headache, fever, nausea, dizziness, and injection-site reactions. The duration of immunity has not been established.
GARDASIL should be administered intramuscularly in the deltoid or anterolateral area of the thigh, with a complete vaccination regimen consisting of 3 doses at 0, 2, and 6 months for individuals 9 through 26 years of age.
Merck's Commitment to Global Access
Merck (search) has invested over $2 billion to increase the manufacturing capacity of its HPV (search) vaccines. The company reaffirmed its commitment to Gavi, the Vaccine Alliance, through an agreement with UNICEF, to supply low- and middle-income countries with over 115 million doses of HPV vaccine by 2025.