MedImmune Submits Supplemental Biologics License Application for Quadrivalent Seasonal Nasal Spray Influenza Vaccine

GAITHERSBURG, Md., July 18, 2011 /PRNewswire/ -- MedImmune has received confirmation from the U.S. Food & Drug Administration (FDA) that the Agency has filed the Company's supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist® (Influenza Vaccine Live, Intranasal). The company submitted the sBLA early in the second quarter of this year.

Currently licensed seasonal influenza vaccines are trivalent, containing three strains (two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain).  However, as influenza B strains from 2 different lineages have circulated in recent years (B/Yamagata and B/Victoria) the quadrivalent vaccine contains four strains: A/H1N1, A/H3N2, and B strains from both of the B lineages.  The quadrivalent vaccine is designed to offer protection against a broader range of B strains and reinforces MedImmune's commitment to innovation within the infectious disease area.

Historically, seasonal flu vaccines have contained three strains recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). Their recommendation is based on global public health officials' best prediction nearly 8 months prior to the start of the influenza season as to which strains will predominate during the upcoming season and therefore are most likely to pose the greatest public health risk.

"According to the Centers for Disease Control and Prevention (CDC), since the 2001-2002 season, influenza B viruses from both lineages have co-circulated during most influenza seasons in the USA, and it has been difficult to accurately predict the correct lineage to include in the seasonal vaccine," said Robert Belshe, M.D., director of the Center for Vaccine Development  Saint Louis University. "In fact, in the United States, in a recent 10 year interval of influenza seasons, the predominant circulating influenza B lineage was different in 5 seasons from the one selected for inclusion in the vaccine."

In pivotal clinical studies conducted in adults and children, the quadrivalent live attenuated influenza vaccine (Q/LAIV) was compared to two trivalent formulations of MedImmune's licensed seasonal influenza vaccine, FluMist (Influenza Vaccine Live, Intranasal).  The quadrivalent vaccine induced immune responses to both B strains and the immune responses for all of the four strains in the vaccine were comparable to the immune responses induced by the trivalent vaccines. Additionally, Q/LAIV had a comparable safety profile to the trivalent FluMist formulations in the indicated FluMist population (eligible individuals 2-49 years of age).

"We believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate," said Filip Dubovsky, M.D., MedImmune's vice president of Clinical Development.

Important Safety and Eligibility Information for FluMist

What is FluMist® (Influenza Vaccine Live, Intranasal)?

FluMist is the first and only nasal spray flu vaccine approved in the United States to help prevent influenza and is indicated for the active immunization of eligible individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.

Who may not be able to get FluMist?

You should not get FluMist if you: are allergic to eggs, gentamicin, gelatin, or arginine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin–children or adolescents should not be given aspirin for 4 weeks after getting FluMist unless your healthcare provider tells you otherwise.

Children under 2 years old should not get FluMist because there is a chance they may wheeze (have difficulty with breathing) after getting FluMist.

Tell your healthcare provider if you: are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barre syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.

They will decide if FluMist is right for you.

What are the most common side effects of FluMist?

The most common side effects of FluMist are runny or stuffy nose; sore throat; and fever over 100 degrees F.

Please see accompanying complete product information, including patient information at www.medimmune.com.

For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the global biologics unit for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune's website at www.medimmune.com.

SOURCE MedImmune