The China National Medical Products Administration (NMPA) has granted expanded approval to MSD's GARDASIL, [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for use in males aged nine to 26 years.

It is indicated to prevent certain human papillomavirus (HPV)-related cancers and conditions and marks the first approval of an HPV vaccine for males in the country.

GARDASIL, which is no longer marketed in the US, is now authorised in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts due to HPV Types 6 and 11, and various precancerous or dysplastic lesions.

The company noted that the vaccine is also indicated for females aged nine to 45 years to prevent vulvar, vaginal, anal and cervical cancers, as well as precancerous lesions and genital warts caused by specific HPV types.

MSD Human Health International president Joseph Romanelli stated: “The approval of GARDASIL for use in males nine to 26 years old in China is a significant step forward in advancing public health.

“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.”

MSD has invested more than $2bn in capital to enhance manufacturing capabilities, resulting in a significant increase in vaccine supply.

In 2024, the company signed an agreement with UNICEF to provide 115 million doses of the HPV vaccine to Gavi (the Vaccine Alliance). The initiative supports immunisation programmes in low and middle-income countries.

In March 2024, the company announced its plans to commence two prospective clinical trials to evaluate the efficacy and safety of a single-dose regimen of its multivalent HPV vaccine, Gardasil 9.