EMA recommends approval of two influenza A vaccines in Europe – Society

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions on two vaccines for active immunization against the H5N1 subtype of influenza A virus, also known as avian influenza.

One, called “Celldemic,” is designed to immunize animals during outbreaks of influenza, even when public health authorities anticipate a potential pandemic.

The other is “Incellipan” (pandemic influenza vaccine (H5N1)), which is a pandemic preparedness vaccine that is only used when an influenza pandemic is officially declared.

In the event of a pandemic, once the virus strain causing the pandemic is identified, manufacturers can include that strain in an authorized pandemic preparedness vaccine and require that the vaccine be authorized as a “definitive” vaccine against the pandemic.

Authorization of a final pandemic vaccine could be expedited now that the vaccine’s quality, safety and efficacy have been evaluated against other potential pandemic strains.