China expands approval of Merck's HPV vaccine to males

Merck has announced that its GARDASIL vaccine has received expanded approval for males in China, the first such indication in the country.

New Jersey-based Merck, which does business outside of the United States as Merck Sharp & Dohme, said that China's National Medical Products Administration (NMPA) last week approved GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males aged between 9 and 26 years to help prevent certain HPV-related cancers and diseases.

The latest approval makes it the first HPV vaccine approved for use among males in 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 Merck's Human Health International.

"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."

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).

HPV is a common cause of cervical cancer in women, and it also increases the risk of genital warts and several types of cancers among men.

Three other HPV vaccines, including an imported jab, are available in China currently but they only target women.

Medical experts have been calling for wider coverage of the vaccination as a crucial part of gynecological disease prevention and control.

Vaccination is a key measure in the national 2030 blueprint for promoting cervical cancer prevention and treatment, and the new schemes are believed to further boost the promotion and easier access to HPV vaccination.

China accounts for 18.2 percent of global cervical cancer cases and 17.3 percent of global cancer deaths due to its large population, official figures show.

The first HPV cancer vaccine was approved in China seven years ago, and a total of around 21.59 million doses of vaccines were administered to women aged 9-45 years between 2018 and 2020, with an estimated vaccination rate of 2.24 percent.

The National Health Commission approved the extension for eligible women from the previous age range of 16 to 26, to age 9 to 45 in August 2022, in an effort to enhance cervical cancer prevention and control.