Merck’s Gardasil 9-Valent HPV Vaccine Approved for Expanded Age Range in China

US-based Merck Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration (NMPA) has approved an expanded indication for its Gardasil 9-valent human papillomavirus (HPV) vaccine. The vaccine, initially approved for females aged 16–26, can now be administered to females aged 9–45.

Vaccine Details

  • Immunization Schedule: Requires a three-dose regimen.
  • Coverage: Protects against cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Also prevents cervical intraepithelial neoplasia (CIN1/2/3), cervical adenocarcinoma in situ (AIS), and persistent infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Epidemiological Context

  • In 2020, cervical cancer incidence and mortality among Chinese females aged 15–44 ranked third among female tumors.
  • ~98% of cervical cancers in China are linked to high-risk HPV types.
  • HPV 16, 52, and 58 are the most prevalent high-risk types among Chinese women.

Vaccination Benefits

  • Vaccination in adolescent girls elicits stronger immune responses.
  • Women who have not had sex benefit most, but vaccination remains effective for sexually active women.
  • Older age reduces the ability to clear HPV infections, increasing cancer risk.-Fineline Info & Tech
Insight, China's Pharmaceutical Industry