EU Issues Strategy for Influenza A (H1N1) Vaccine Benefit–Risk Monitoring

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

The European Medicines Agency (EMEA), the European Center for Disease Prevention and Control (ECDC), and the Heads of Medicines Agencies (HMA) issued on Nov. 5, 2009, a European strategy for influenza A (H1N1) vaccine benefit–risk monitoring.

The report specifies that the main responsibility for monitoring the safety and effectiveness of vaccines lies with vaccine manufacturers. As specified by EMEA’s Committee of Human Medicinal Products, these activities include conducting a prospective safety cohort study for each vaccine; surveillance of adverse events of special interest; monitoring of special population groups such as pregnant women, children, and immunocompromised subjects; and conducting studies on effectiveness and immunogenicity. These responsibilities are in addition to routine regulatory requirements.

The report points out that during the course of mass vaccination, data may also be generated by public-health centers, specialists, academic research institutions, sentinel networks, and other groups in relation to the safety and effectiveness of H1N1 vaccines. These data are important for the identification and evaluation of any new issue that may arise during the vaccination. As a result, the strategy seeks to establish interactions between various groups, national competent authorities, public-health institutions, EMEA, and ECDC to strengthen the monitoring of the benefits and risks of the vaccines.


The strategy has three major components-safety, effectiveness, and immunogenicity-that support an evidence-based benefit–risk evaluation. The strategy details the role and responsibilities of vaccine manufacturers, European Union member states, rapporteurs and corapporteurs, the CHMP and its working parties, EMEA, ECDC, and research, clinical, and public-health centers.