Merck, also known as MSD in regions outside the U.S. and Canada, has shared that China’s National Medical Products Administration (NMPA) has granted approval for GARDASIL® [Human Papillomavirus Quadrivalent Vaccine (Types 6, 11, 16, and 18), Recombinant] to be used in males between the ages of 9 and 26. This approval will help prevent certain cancers and diseases associated with HPV. GARDASIL is now the first HPV vaccine authorized for male use in China. The vaccine is approved to prevent anal cancers caused by HPV Types 16 and 18, genital warts from HPV Types 6 and 11, and precancerous lesions like grade 1, 2, and 3 anal intraepithelial neoplasia (AIN) caused by HPV Types 6, 11, 16, and 18.
Joseph Romanelli, President of Merck’s Human Health International division, shared that this approval is a significant advancement for public health. He mentioned that since its initial approval, over 50 million women in China have been protected from HPV-related diseases through Merck’s HPV vaccines. With this latest approval, Merck is eager to extend protection to Chinese males against specific HPV-related cancers and diseases.
Indications for GARDASIL:
- For females between the ages of 9 to 45: GARDASIL is used to prevent cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, as well as precancerous lesions from HPV Types 6, 11, 16, and 18, and genital warts from HPV Types 6 and 11.
- For males between the ages of 9 and 26: GARDASIL helps protect against anal cancer linked to HPV Types 16 and 18, as well as precancerous lesions from 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 replace the need for regular screenings for cervical, vulvar, vaginal, and anal cancers as recommended by healthcare providers. The vaccine also does not protect against HPV types not covered by the vaccine or types to which a person has already been exposed. GARDASIL only protects against HPV-related cancers caused by the specific HPV types covered by the vaccine.
In addition, GARDASIL is not meant to treat any existing genital lesions or cancers, including those of the cervix, vulva, vagina, anus, or head and neck.
Merck’s Global Commitment to HPV Vaccines:
Merck is committed to ensuring a global supply of HPV vaccines and broad, equitable access to help protect against HPV-related cancers. To meet this commitment, Merck has invested over $2 billion to increase production capacity and meet rising global demand. Between 2017 and 2024, the supply of HPV vaccines was doubled multiple times to keep up with demand, and Merck continues to expand its supply capacity.
In 2024, Merck reaffirmed its commitment to Gavi, the Vaccine Alliance, by partnering with UNICEF to supply over 115 million doses of the HPV vaccine to low- and middle-income countries by 2025, supporting local immunization programs. Additionally, Merck is working to ensure a steady supply to countries with established HPV vaccination programs and is currently supplying approximately 150 National Immunization Programs worldwide.