by LI Kewen
Merck & Co. Inc., the U.S. pharmaceutical company known as MSD outside North America, has withdrawn its Vaqta® hepatitis A vaccine from the Chinese market, highlighting China's shift toward locally made vaccines.
The National Medical Products Administration (NMPA) said on October 15 it had canceled the product's market authorization at the company's request, in accordance with Chinese drug registration rules.
The withdrawal ends the presence of the only foreign-made hepatitis A vaccine in China and leaves five domestic producers — Beijing Sinovac Biotech, the Institute of Medical Biology of the Chinese Academy of Medical Sciences, AIM Vaccine, Zhejiang Prokang Biotech, and the Changchun Institute of Biological Products — as suppliers of approved hepatitis A vaccines in the country.
Merck's vaccine, first approved in China in 1999, had faced nationwide shortages since early 2024 as its license neared expiry. Official data show only one production batch approved between 2024 and October 2025, down from two in 2023. Merck said the withdrawal was part of a global business review and reflected confidence that local manufacturers could meet market demand.
The withdrawal reflects how global pharmaceutical firms are rethinking their vaccine strategies in China amid intensifying local competition and regulatory pressures. Some multinationals, such as GSK, have trimmed delivery volumes under revised vaccine agreements in China, while Sanofi suspended distribution of certain flu vaccines after internal quality tests raised concerns.
Health experts said the impact on vaccination schedules would be limited. China's National Immunization Program Guidelines (2021 edition) allow children who received one dose of an imported inactivated hepatitis A vaccine to complete the series with a locally produced equivalent after at least six months.
Clinical data published in the Chinese Journal of Epidemiology found that locally produced inactivated and live-attenuated hepatitis A vaccines offer comparable safety and immune response to imported products.
