01 April 2016
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that 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. This provides an additional public health tool to protect European children when the next pandemic emerges.
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 AstraZeneca/MedImmune’s approved 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 as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.
The CHMP’s opinion will now be advanced to the European Commission for adoption of a decision on EU-wide marketing authorisation of the vaccine as a pandemic preparedness vaccine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
NOTES TO EDITORS
About Influenza Pandemics
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.
FluMist® Quadrivalent (US brand name) / Fluenz™ Tetra (EU brand name) is the only widely available quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray and contains four protective strains for the prevention of influenza.
FluMist was originally approved in the US in 2003 and since the original approval, more than 100 million doses have been distributed around the world. Since 2013 it has become the vaccine of choice in the UK’s largest pediatric vaccine programme and preferential recommendations have also been adopted by vaccine advisory groups in Canada, Finland, Sweden (high-risk individuals) and Germany (high-risk individuals). A general recommendation for quadrivalent LAIV in people aged two to 49 has been adopted in the US.
MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal