Product Name: Rabies Vaccine (Vero Cell) for Human Use
Approval No.: S20060076
Vacome’s Rabies Vaccine (Vero Cell) for Human Use is made from the inactivated rabies fixed virus (aGV), adopting suspension culture on microcarriers, and after ultrafiltration concentrated, inactivated and purified to make the vaccine which owns good reproducibility of cultural system, and uniformity and stability product quality. The vaccine shows good safety and immunogenicity, lightly adverse reaction and more benefit for large-scope vaccination in exposure area, which is the first independent research and development adopting bioreactor microcarrier technology of rabies vaccine for human use in China. It owns the following characters:
In-house potency is not less than 4.0 IU/dose, which is much higher than 2.5IU/dose of Chinese Pharmacopoeia.
No adjuvant, which can rapidly generate high levels of protective antibodies after vaccination.
The origin and generation of Vero cell is very clear, and with very low residual of DNA, which assure final product has no oncogenicity.
The standards for contents of bacterial endotoxin, total protein and residual bovine serum albumin etc. are obviously superior to the standard of Chinese Pharmacopoeia, largely avoid the occurrence of side effects like fever, erythra and etc.
Potency is not less than 2.5 IU/dose after store at 2~8 ℃ for 18 months.
Potency is not less than 2.5 IU/dose after store at 37 ℃ for 2 weeks which is convenient for the storage and transportation, which assures to generate enough antibody after vaccination.