Analysis of post-marketing safety monitoring of split influenza virus vaccine based on large samples / 公共卫生与预防医学

ABSTRACT

Objective To evaluate the safety of a Chinese thimerosal-free trivalent split influenza virus vaccine after being marketed in a large population. Methods Through the information management system of adverse event following immunization (AEFI), the adverse events in healthy people aged 6 months and above who were vaccinated with split influenza virus vaccine in Hubei Province from October to December 2015 were collected. The data was analyzed by descriptive methodology. Results From October 1, 2015 to June 30, 2016, among the 227 920 people in Hubei Province who were vaccinated with split influenza virus vaccine, the common adverse reactions were mainly fever, redness, irritability, pain and itching. Four cases of AEFI were passively observed and reported in the system, with a reporting rate of 1.76/100 000, among which 3 cases were anaphylactic rash and 1 case was optic neuritis. Conclusion The Chinese thimerosal-free trivalent split influenza virus vaccine used in Hubei Province had a good safety record and is suitable for the general vaccination of people without vaccination contraindications.