EMEA ISSUES GUIDANCE ON PANDEMIC FLU VACCINE APPLICATIONS

The European Medicines Agency (EMEA) has issued a guidance on marketing authorization applications of pandemic influenza vaccines. The draft document also includes guidance on postmarketing commitments and risk management plans.

Specifically, the guidance addresses quality, preclinical and clinical data requirements for applications for so-called mock-up vaccines derived from avian influenza strains. These vaccines would be developed before the onset of a pandemic and would have to be modified with the correct human strain once the World Health Organization declares a pandemic state.

The guidance addresses only inactive vaccines produced from eggs or cell cultures, not live, attenuated vaccines.