The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine ( P/LAIV ).
P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.
This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared.
Once the World Health Organisation has declared an actual pandemic, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval.
P/LAIV is an intranasally administered vaccine that contains a live attenuated H5N1 strain of influenza virus. The vaccine is based on the same biologically-active components currently used to make seasonal influenza vaccine, Fluenz Tetra.
P/LAIV differs from Fluenz Tetra, because it protects against a single influenza A pandemic strain as opposed to four seasonal strains in Fluenz Tetra.
The positive CHMP opinion was based on a review of safety and immunogenicity studies of the H5N1 vaccine conducted in collaboration with the US National Institutes of Health ( NIH ) as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.
Influenza pandemics are defined as world-wide flu epidemics with high levels of morbidity and mortality. An influenza pandemic can occur when a non-human ( novel ) influenza virus for which individuals have limited or no immunity gains the ability to be transmitted easily between humans and then spreads globally.
The last pandemic occurred in 2009 and the global mortality rate has been estimated between 18,000 and 186,300 deaths.
Source: AstraZeneca / MedImmune, 2016