Merck's Hepatitis A Vaccine Exits Chinese Market Amid Strategic Shift

Recently, it has been reported that MSD will cease sales of its inactivated hepatitis A vaccine, Vaqta, in China. The company has confirmed this decision, stating that it is a business adjustment made due to the global strategic realignment, reassessment of R&D and production resources, and confidence that domestically produced products can meet market demand.

The previous large-scale stockouts had already shown early signs.

Before Vivat officially exited the Chinese market, a supply shortage of the vaccine had already begun to appear in some regions of China as early as February this year. MSD explained at the time that the production process of the vaccine was complex and required strict quality control, and the supply of imported vaccines might be affected by various unpredictable factors such as logistics. However, data shows that Vivat only received two batch releases throughout 2023, which could be the deeper reason behind the supply shortage.

Image Source: National Institutes for Food and Drug Control, China

Currently, four specifications of the VaxTrac vaccine have been approved in the Chinese market.The registration certificate is valid until July 15, 2025. This means that after this date, the vaccine will not be able to be newly imported into China.。

Five local companies have been approved in China.

In China, besides MSD, five local enterprises have obtained the production approval for hepatitis A vaccines, including Beijing Sinovac Biotech, Walvax Biotechnology, Zhejiang Pukang Biotechnology, Changchun Institute of Biological Products, and the Institute of Medical Biology, Chinese Academy of Medical Sciences. The vaccines produced by these enterprises include both inactivated and attenuated live vaccines, with the latter being divided into regular and freeze-dried forms based on different storage conditions and time requirements.

Image Source: National Medical Products Administration

According to the report by Zhiyanzhan Industry Research Institute, the market size of hepatitis A vaccines in China reached 1.261 billion yuan in 2018, with a growth rate of 15.6%. By the first quarter of 2023, the market size had increased to 1.357 billion yuan, with a growth rate of 6.52%. It is expected that by 2029, the market size will grow to 7.578 billion yuan.

Hecolin, the hepatitis A vaccine developed by Sinovac Biotech, is China's first independently researched and developed inactivated hepatitis A vaccine. Since its market launch in 2002, it has become the most widely used and exported inactivated hepatitis A vaccine in China. With MSD's exit from the Chinese market, local companies are expected to gain more market share and have the opportunity to improve product quality and competitiveness to better serve the domestic market.