MEDIMMUNE ANNOUNCES FDA APPROVAL OF FIRST FOUR-STRAIN FLU VACCINE, FLUMIST® QUADRIVALENT (INFLUENZA VACCINE LIVE, INTRANASAL)
GAITHERSBURG, MD, February 29, 2012 – MedImmune today announced that the U.S. Food and Drug Administration (FDA) has approved FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) for prevention of influenza. The company submitted the sBLA early in the second quarter of last year. FluMist Quadrivalent is the first quadrivalent influenza vaccine approved by the FDA.
All other currently available 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]. FluMist Quadrivalent contains four strains (two type A strains and two type B lineages) to help provide broad protection against circulating influenza A and B.
In recent years, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have circulated. The quadrivalent vaccine includes strains from both lineages, helping provide protection against both B lineages. The first of its kind approval for FluMist Quadrivalent reinforces MedImmune's commitment to innovation within the infectious disease area.
"According to the Centers for Disease Control and Prevention (CDC), since the 2001-2002 season, influenza B viruses from both lineages have co-circulated in the USA," said Stan Block, MD, FAAP, Professor of Clinical Pediatrics at the University of Kentucky College of Medicine in Lexingtonand at the University of Louisville School of Medicine. "In the United States, in 5-of-the-10 influenza seasons between 2001 and 2011, the predominant circulating influenza B lineage was different from the one selected for inclusion in the trivalent vaccines. The CDC has estimated that between 2001 and 2009, 2.7 million fewer Americans would have gotten the flu if all influenza vaccines had been quadrivalent.[1]"
In pivotal clinical studies conducted in children and adults 2-49 years of age, FluMist Quadrivalent was compared to two trivalent formulations of MedImmune's licensed seasonal influenza vaccine, FluMist (Influenza Vaccine Live, Intranasal).
FluMist Quadrivalent had a safety profile generally comparable to the trivalent FluMist formulations, and immunogenicity to individual vaccine strains was comparable in trivalent and quadrivalent formulations. Further, the addition of the second B strain did not result in immune interference to other strains included in the vaccine.
"This is the first quadrivalent influenza vaccine approved and MedImmune is pleased to be able to take the next steps in making this product available to the public. 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 Bahija Jallal, MedImmune's executive vice president of Research and Development.
IMPORTANT SAFETY AND ELIGIBILITY INFORMATION
What is FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)?
FluMist Quadrivalent is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FluMist Quadrivalent is similar to MedImmune's trivalent Influenza Vaccine Live, Intranasal (FluMist), except FluMist Quadrivalent provides protection against an additional influenza strain. FluMist Quadrivalent may not prevent influenza in everyone who gets vaccinated.
Who should not get FluMist Quadrivalent?
You should not get FluMist Quadrivalent if you have a severe allergy 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 or FluMist Quadrivalent unless your healthcare provider tells you otherwise.
Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.
Who may not be able to get FluMist Quadrivalent?
Tell your healthcare provider if you or your child are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré 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.
Your healthcare provider will decide if FluMist Quadrivalent is right for you or your child.
What are the most common side effects of FluMist Quadrivalent?
The most common side effects are runny or stuffy nose, sore throat, and fever over 100F.
Please see accompanying complete Product Information, including Patient Information
at http://www.medimmune.com/pdf/products/flumistquad_pi.pdf
About MedImmune
MedImmune, the global biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune's website at http://www.medimmune.com/
# # #
[1] Reed C, et al. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine (2012), doi:10.1016/j.vaccine.2011.12.098