China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled design, has indicated good safety from the first dose to 7 days after the entire immunization period.
Study Results and Significance
The results of the Phase III study are significant as no serum-free rabies vaccine has been approved for marketing in China to date. The vaccine is produced by inoculating serum-free Vero cells with a fixed strain of the rabies virus, offering the advantage of reduced adverse reactions such as allergies and fever during use. This characteristic is particularly important for enhancing the safety profile of the vaccine.
Production Capacity and Future Outlook
A facility for the production of this vaccine has already been completed, with a capacity to manufacture 50 million doses. This readiness for scale-up production, combined with the positive safety results from the clinical trial, positions AIM Vaccine’s serum-free rabies vaccine as a potentially important advancement in the prevention of rabies.-Fineline Info & Tech
