Closely monitor the H1N1 vaccine adverse reactions
Posted on November 17, 2009
Filed Under H1N1 Prevention | Leave a Comment
September 10 morning, a child is Wenling City, Zhejiang Province Taiping public health influenza vaccination. With the arrival of flu season over, many parents with children to come vaccinated.
September 10, Beijing 60 years old or older and in the primary and secondary schools free influenza vaccination begins, ending October 31. Primary and secondary students in school is a half-influenza vaccination in previous years on the basis of the first to receive free vaccination. Currently, Beijing 489 compliance immunization clinic has been fully started influenza vaccination efforts will provide vaccination services all day on Saturdays and Sundays uninterrupted.
In response to the spread of Influenza A H1N1 influenza, the State Food and Drug Administration recently issued a notice requirement from 4 to earnestly strengthen a sense of vaccine development, and production supervision of all sectors to ensure quality and safety of vaccine production. Highly concerned about a flu vaccine for adverse reactions, upon receipt of the report of adverse reactions should immediately contact the local disease control agencies to actively support the disease control agency investigated the diagnosis, level by level according to the provisions of the report.
The circular points out, first of all to continue to pay close attention to the review of approval of the vaccine.
Second, the strict supervision of vaccine production and storage and transportation, the strict implementation of approved a flu vaccine manufacturing and quality control procedures, and organized the production on-site inspection, assigning supervisors stationed enterprises, strengthen the links of the production process and the overall control process to ensure product quality and batch uniformity among products. Strengthen the vaccine electronic monitoring and effectively to achieve traceability of vaccines can be traced. Found in the supervision and inspection of the vaccine quality problems or that may affect the final product quality problems, the relevant provincial Drug Administration departments should take immediate and effective control measures, shall be ordered to suspend production for rectification companies to recall products.
Third, China’s pharmaceutical and biological products must be strictly carried out according to the procedures and time limits Batch Release A flu vaccine products to ensure quality and safety of every batch of vaccine.
Fourth, the close monitoring of vaccine adverse reactions, the relevant Provincial Food and Drug Administration shall supervise the enterprises to improve their risk management of large-scale population immunity and the pharmacovigilance plan, initiated a flu vaccine adverse events reporting, investigation, analysis, evaluation and processing. National Adverse Drug Reaction Monitoring Center and at all levels of adverse drug reactions monitoring bodies should be highly concerned about a flu vaccine for adverse reactions, upon receipt of the report of adverse reactions should immediately contact the local disease control agencies to actively support the disease control agency investigated the diagnosis, a comprehensive analysis of and science to determine, in accordance with the provisions of the report level by level.
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