Nijmegen, The Netherlands (ots/PRNewswire) -
MedImmune, the global biologics unit of AstraZeneca, announced
today that it has submitted a Marketing Authorisation Application
(MAA) for its nasal spray live attenuated influenza vaccine (LAIV),
which is now being reviewed by the European Medicines Agency (EMEA).
The proposed indication in the MAA is for prevention of seasonal
The MAA submission for LAIV is based on data from 73 global
clinical and U.S. post-marketing studies of more than 141,000
subjects ranging in age from 7 weeks to 97 years and conducted in 38
countries. Study objectives have included clinical safety and
tolerability, clinical efficacy and effectiveness, and
"Influenza creates a heavy medical and economic burden on Europe
and throughout the world, and we are hopeful that the future
availability and product characteristics of this novel nasal spray
influenza vaccine will contribute to an increase in vaccination rates
and reduce the spread of influenza around the world," said Alex
Zukiwski, M.D., executive vice president, clinical affairs and chief
medical officer. "MedImmune is pleased to submit this application for
approval of our nasal spray influenza vaccine in Europe."
Each dose of LAIV is formulated to contain three live attenuated
influenza virus strains, which are weakened as to not cause illness:
Two Type A influenza strains (A/H1N1 and A/H3N2) and one Type B
strain. 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 sprayed into the nose, rather
than by injection as with other licensed influenza vaccines, where it
induces protective immunity.
In the U.S., LAIV is marketed under the trade name FluMist(R)
(Influenza Virus Vaccine Live, Intranasal). It was approved by the
U.S. Food and Drug Administration in 2003. The vaccine included in
the MAA has not been registered in the European Union (EU) and is not
available outside of the United States.
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.
Influenza also has socioeconomic consequences related to both
direct and indirect health care costs, including hospitalizations,
work absence and loss of work productivity when either a caregiver or
child is sick with influenza.
In the EU, current guidelines recommend annual influenza
vaccination for the elderly as well as those with underlying medical
conditions such as chronic heart or lung disease. However,
vaccination rates in the recommended groups throughout Europe are
estimated to be only 35 percent (Ryan, Vaccine, August 2006).
To date, six EU countries (Finland, Austria, Estonia, Latvia,
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 is a leading innovation-focused biotechnology company
whose mission is to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated
to advancing science and medicine to help people live better lives,
the company is focused on infection, oncology, respiratory disease
and inflammation, cardiovascular/gastrointestinal disease and
neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has
approximately 3,000 employees worldwide and is the wholly owned
biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN). For
more information, visit MedImmune's website at
ots Originaltext: MedImmune, Inc.
Im Internet recherchierbar: http://www.presseportal.ch
Media, Chris Sampson, +44-(0)-207-304-5130, Sarah Lindgreen,
+44-(0)-207-304-5033, both of AstraZeneca; Karen Lancaster of
MedImmune, Inc., +1-301-398-5864; NOTE TO EDITORS: Attention:
European Media -- Not intended for U.S. audiences