Navigation Links
FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Date:12/23/2009

Accelerated approval process used in vaccine approval

SILVER SPRING, Md., Dec. 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA's accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

"As people grow older, their immune systems typically become weaker," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

For more information:

FDA Web Page on Vaccines, Blood & Biologics

http://www.fda.gov/BiologicsBloodVaccines/default.htm.


    Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/12/2017)... 12, 2017 Kineta, Inc., a biotechnology company focused ... Vice President of R&D and Head of Virology Kristin ... Preparedness for the Northwest and Beyond meeting sponsored by ... 14, 2017 from 8:30-10:30 AM PDT at the Agora Conference ... Dr. Bedard will be joined by other leaders in ...
(Date:6/9/2017)... ALTO, Calif. , June 9, 2017 ... device company focused on the design, manufacture, sale and ... the market on the progress of its commercial roll-out ... is now available in more than one hundred (100) ... AeroForm offers a needle-free alternative for ...
(Date:6/8/2017)... 2017   Responding to Heath Ledger,s father,s ... of singer Chris Cornell in May, the mental ... a free online psychiatric drug side effects ... about psychotropic drug risks. The father of ... an accidental overdose, has called for tighter rules on prescription ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Yesterday, U.S. Senate Republicans revealed ... repeal and replace the Affordable Care Act (ACA). Like the bill narrowly passed ... Medicaid, a public health insurance program for low-income children, pregnant women, parents of ...
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection ... denied entry to the JFK Virgin Atlantic lounge. , Bensko is no stranger ... six years ago, Bensko dedicated her life to supporting our wounded veterans. A world-class ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... and two new videos highlight the importance of correctly using a meat thermometer. ... who has done extensive research on consumer food safety habits. Dr. Bruhn explains ...
(Date:6/23/2017)... ... ... PureLife Dental is pleased to announce that California Dental Association (CDA) has ... the amalgam separator endorsement, all CDA members may purchase an ECO II amalgam separator ... This partnership between PureLife and CDA is especially timely as it coincides with the ...
(Date:6/23/2017)... ... 23, 2017 , ... The Katyl Agency, a locally owned ... business owners in and around Lackawanna County, is joining Meals On Wheels of ... , Meals on Wheels of NEPA provides hand-delivered and nutritious meals to seniors ...
Breaking Medicine News(10 mins):