Navigation Links
MedImmune Announces FDA Approval of First Four-strain Flu Vaccine, FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)
Date:2/29/2012

GAITHERSBURG, Md., Feb. 29, 2012 /PRNewswire/ -- 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 Lexington and 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-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.

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 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


'/>"/>
SOURCE MedImmune
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AgonOx Partners with MedImmune for Development of OX40 Agonists in Cancer Therapy
2. MedImmune To Present Eight Abstracts on Projects Regarding Thoracic and Respiratory Issues at the Annual American Thoracic Society International Conference
3. Pfenex Announces Strategic Collaboration With MedImmune for the Use of Pfenex Expression Technology™
4. MedImmune to Present 11 Abstracts on Influenza at 45th Annual National Immunization Conference
5. MedImmune In-Licenses Clinical-Stage Anti-Inflammatory Monoclonal Antibody From Amgen
6. MedImmune Announces Winners of the 5th Annual Respiratory, Inflammation and Autoimmunity Research Abstract Competition
7. MedImmune Focused on Revolutionizing Cancer Care
8. MedImmune to Present Five Abstracts on RSV at Pediatric Academic Societies Annual Meeting
9. MedImmune to Present Data on RSV and Influenza at 2009 American Academy of Pediatrics National Conference & Exhibition
10. MedImmune Funds Study to Help Gain Insights Into Full Burden of RSV Disease Among Premature Infants
11. MedImmune Presents New Data Demonstrating Increased Risk for Medically Attended RSV in Late-Preterm Infants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
Breaking Medicine News(10 mins):