EMEA PUBLISHES GUIDELINE ON PANDEMIC VACCINE SUBMISSIONS

The European Medicines Agency (EMEA) has posted on its website a guideline on influenza vaccines produced from viruses with the potential to cause a pandemic, which went into effect Feb. 1.

The guideline addresses the quality, non-clinical and clinical submission requirements for influenza vaccines prepared from viruses with a pandemic potential that are intended for use outside of the context of a core application. It also gives guidance on postapproval commitments and risk management plans.

The submission requirements for such vaccines are based on the assumption that mock-up influenza vaccine would be developed in the prepandemic period and then, in an officially declared pandemic situation, the pandemic vaccine would be approved following the insertion of the relevant virus strain.

The guideline addresses the content of marketing authorization applications for inactivated influenza vaccines produced from viruses grown in eggs or in cell cultures, not live attenuated vaccines.

The guideline can be viewed at www.emea.eu.int/pdfs/human/vwp/26349906enfin.pdf.