Post-marketing safety monitoring of a domestic live attenuated varicella vaccine

Objective To evaluate the post-marketing safety of a domestic varicella vaccine. Methods In Xinye county (Henan Province), Longhui county (Hunan Province), and Songzi city (Hubei Province), the voluntary vaccination was routinely performed in healthy 1-12 year-old children with no history of varicella disease or varicella vaccination. The adverse reactions were documented and analyzed at 30 min, 24 h, 48 h, 72 h, 7 d, 14 d, and 28 d after inoculation. Results Twelve adverse cases were reported in a total of 9 135 subjects surveyed, with the adverse reaction rate of 0.13%. Systemic reactions were mainly mild or moderate fever. The adverse reactions appeared primarily within 48 h after vaccination, and were self-healed 72 h later. The adverse reaction rates among various age groups (χ2=1.933, P=0.383)and batches of vaccines (χ2=5.859, P=0.080) used showed no significant difference. Conclusion This domestic varicella vaccine has good safety in target population. Key words: Chickenpox Vaccine; Vaccination; Adverse reactions; Safety