HQ Team
January 9, 2025: China has approved Merck & Co.’s human papillomavirus vaccine for males between nine and 26 years amid a fall in sales for the jab among women in the world’s most populous country, according to a company statement.
The vaccine prevents human papillomavirus (HPV)-related cancers and diseases such as genital warts. It was approved for males by the National Medical Products Administration of China.
“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, of 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,” he said.
Genital warts
Merck’s vaccine is indicated for the prevention of anal cancer caused by certain types of HPV, precancerous or dysplastic lesions, and for the prevention of genital warts caused by the virus.
The vaccine 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.
A complete vaccination regimen for individuals nine through 26 years of age consists of three doses at 0, 2 and 6 months.
Merck has invested $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand.
Gardasil revenue declines
In 2024, Merck 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, to appropriately support local immunization programs. Merck has consistently increased our supply commitment to Gavi from 1.7 million doses in 2017 to more than 30 million doses in 2024.
The approval for the use of the vaccine in males comes at a time when sales are falling in China, which approved the vaccine for females in 2017.
In the third quarter of the financial year ended September 30, revenue from the vaccine fell 11% to $2.31 billion.
Third-quarter Gardasil sales declined year-over-year due to reduced demand in China. Outside of China, the company achieved double-digit sales growth for Gardasil in almost every major region globally.
