EMA Revises “Pandemic Preparedness” Pathway for Flu Vaccine Development

The EMA is introducing a replacement pathway for developing flu vaccines in advance of a global outbreak.

In a final guidance, the agency replaced its mock-up approval program with a new pathway dubbed “pandemic preparedness.” This pathway emphasizes industry’s role in preparing for potential influenza pandemics.

Under this pathway, influenza vaccines will be developed with emergent virus strains of animal origin that have potential to spread to people and trigger a pandemic. This contrasts with the model used in the mock-up program, which relied on virus strains that had pandemic potential but had only been seen in humans a handful of times.