December 29, 2025
Source: drugdu
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On December 26, 2025, the first batch of adsorbed tetanus vaccine developed and produced by Beijing Sinovac Biotech Co., Ltd., a subsidiary of Sinovac Biotech, was shipped, officially entering the market. The vaccine, which received registration approval from the National Medical Products Administration in August 2025, represents the culmination of more than four years of research and development efforts, marking a new domestically produced option for tetanus active immunization in my country. Tetanus is an acute toxic disease caused by Clostridium tetani, which enters through breaks in the skin or mucous membranes. Globally, there are approximately one million cases annually, with 300,000 to 500,000 deaths. Without medical intervention, the mortality rate is nearly 100%, and even with standardized treatment, the global mortality rate remains between 30% and 50%. In my country, the overall level of tetanus protection among the adult population is insufficient. Traditional passive immunization agents have limitations such as a high risk of hypersensitivity reactions and short duration of protection. Significant gaps exist in prevention in key settings such as emergency departments, making the prevention and control situation severe. Vaccination is the most economical and effective means of preventing this disease.
Sinovac's adsorbed tetanus vaccine's core competitiveness stems from innovations in two key areas: adjuvant technology and purification process. On one hand, the vaccine utilizes an innovative nano-sized aluminum hydroxide adjuvant with a particle size of only 300 nanometers. Compared to traditional 1-10 micrometer-sized adjuvants, this allows for more efficient antigen adsorption, significantly improving formulation stability. On the other hand, an upgraded purification process further optimizes the immunogenicity of the vaccine stock solution. Phase III clinical trial data shows that the vaccine's geometric mean concentration (GMC) is superior to the control vaccine, and its safety profile is favorable.
As a key component of Sinovac's "trauma combination product" strategy, the launch of the adsorbed tetanus vaccine synergizes with the group's overall layout in the field of trauma prevention. In recent years, Sinovac has promoted the launch of several innovative products through investment and cooperation: Xingmeng Bio's Class 1 new drug, Krebi®, was approved in 2024 for passive immunization after rabies virus exposure; and the freeze-dried human rabies vaccine produced by Sinovac (Chengdu) Co., Ltd. has successfully won the bid for the Brazilian PDP project and entered the international procurement system.
Sinovac Biotech remains committed to its mission of "providing vaccines to eliminate disease for humanity," continuously focusing on accelerating vaccine research and development, optimizing production processes, and improving global accessibility. Looking ahead, the company will continue to strengthen technological breakthroughs and industry collaboration to help build a more robust public health protection network and contribute Chinese scientific and technological strength to addressing global health challenges.
https://bydrug.pharmcube.com/news/detail/27ed3125b00a995e95050e528b48883b
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