Analysis of the impact of vaccine inserts on vaccination in special health status population in China
10.3760/cma.j.cn112150-20241031-00864
- VernacularTitle:我国疫苗说明书影响特殊健康状态人群疫苗接种的问题分析
- Author:
Tianxing FENG
1
;
Yu SHI
;
Zhuoying HUANG
;
Mei ZENG
Author Information
1. 上海临床研究中心儿科，上海 201203
- Publication Type:Journal Article
- Keywords:
National immunization program vaccines;
Immunization;
Special health status;
Vaccine inserts;
Contraindications;
Precautions
- From:
Chinese Journal of Preventive Medicine
2025;59(9):1475-1482
- CountryChina
- Language:Chinese
-
Abstract:
This study systematically analyzed the package inserts of vaccines purchased centrally for the Chinese national immunization program in 2024. By comparing them with the Childhood Immunization Schedule for National Immunization Program Vaccines-China (Version 2021) and vaccination practice guidelines, this study identified and summarized the limitations and misconceptions in the vaccination descriptions for populations with special health status. Thirty-two vaccine inserts were collected for twelve different types of national immunization program vaccines. An analysis was conducted on the documents for indications, immunization schedules, contraindications, precautions, drug interactions, clinical trial outcomes, and the use of medications in pregnant and lactating women. The primary issues included: rough statements regarding contraindications and precautions for vaccination; special populations with vaccination indications classified as contraindicated or indicated with precautions; immunization schedule without specified procedures and dosage for special populations; unreasonable timeframe for deferring vaccinations after the administration of antibody-containing blood products; absent rational recommendations for concurrent administration with other vaccines and immunosuppressants. Some current vaccine inserts of the national immunization program had broad and unreasonable descriptions of contraindications and precautions, which could affect the vaccination of populations with special health status, causing concerns among healthcare providers and vaccine recipients regarding vaccine safety and leading to vaccine hesitancy. It is recommended to promote evidence-based revision of description on vaccination for populations with special health status in vaccine inserts. Additionally, the principle for vaccinating children with special health status in the Childhood Immunization Schedule for National Immunization Program Vaccines-China (Version 2021) should be further refined to enhance confidence and convenience in vaccination practices.
