EMA Unveils Recommendations for Pandemic Flu Vaccine Applications

Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says.

The applications should explain the type of data missing and whether the data could be generated during a pandemic situation, according to a final guideline.

During an actual pandemic, applications will be evaluated and forwarded to the European Commission in an accelerated process. If no pandemic preparedness vaccines exist, the EMA will consider modifications of seasonal vaccines.

The agency decided to update the guideline on flu vaccine development in the wake of the 2009-2010 influenza pandemic. The final guideline is largely unchanged from a draft version that was released Oct. 30.

Applications for a strain variation must contain a cover letter, a comprehensive table of contents, an application form, and information on the product, labeling, quality expert, chemical-pharmaceutical and biological characteristics, and common technical document summaries.

Read the final guideline here: www.fdanews.com/7-15-EMA-Flu.pdf. — Jonathon Shacat