"We are delighted that FLUENZ has received regulatory approval in Europe since influenza creates a significant medical and economic burden there and throughout the world. We hope that the availability of this nasal spray influenza vaccine with its novel mechanism of action will help reduce the spread of influenza," said Alex Zukiwski, M.D., executive vice president and chief medical officer of MedImmune, the biologics unit of AstraZeneca.
It is expected that the FLUENZ vaccine will be initially available in select European markets for the 2012-13 influenza season.
The EC decision and CHMP positive opinion were reached after a review of data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.
Each dose of FLUENZ is formulated to contain three live attenuated influenza virus strains, which are weakened so as to not cause illness. The vaccine strains are selected annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season.
The vaccine is administered by spraying into the nose where it induces protective immunity. In several clinical studies it has demonstrated superior efficacy in children 24 months to less than 18 years of age compared to traditional inactivated influenza vaccines that are injected. The most common adverse events for LAIV include runny nose or nasal congestion. The live influenza virus strains used in LAIV are cold-adapted, temperature sensitive and attenuated.
In the US, FLUENZ is marketed by MedImmune under the trade name FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by the US Food and Drug Administration in 2003. The seasonal vaccine is currently approved in five countries including the US and Canada.
Influenza is the most common vaccine-preventable disease in the developed world. According to WHO estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year, primarily among the elderly. Rates of infection are highest among children, with school-aged children significantly contributing to spread of disease to their families, communities and high-risk individuals.
Studies in several European countries have demonstrated that hospitalisation rates associated with influenza are highest in young children including those without underlying medical problems (Weigl et al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al, 2007; Jansen et al, 2007). Based on these accumulated data, many experts include young children among those at high risk for severe influenza disease and influenza-related complications (Heikkinen et al, 2006).
Influenza also has socio-economic consequences related to both direct and indirect health care costs, including hospitalisations, work absence and loss of work productivity when either a caregiver or child is sick with influenza.
To date, seven EU countries (Finland, Austria, Estonia, Latvia, the state of Saxony in Germany, Slovakia and Slovenia) recommend routinely vaccinating young children against influenza with varying age limits. EU and Member State policymakers continue to evaluate data on the impact of influenza in children to best inform the potential expansion of recommendations.
MedImmune, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $33.3 billion in 2010.