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:12/8/2016)... 2016  Hanson Research, an innovative leader in ... diffusion testing instruments for the pharmaceutical industry, announced ... Inc. ("Teledyne"). The move is designed to deepen ... instruments, as well as expand resources for further ... and services. Logo - http://photos.prnewswire.com/prnh/20161208/446988LOGO ...
(Date:12/8/2016)... , Dec. 8, 2016  Haemonetics Corporation (NYSE: ... (Donor Management System), an innovative software suite designed to help ... The launch of NextGen DMS 4 improves core features ... the cost per liter of plasma collected, enhancing quality and ... center operations. ...
(Date:12/8/2016)...   Mederi Therapeutics Inc . has announced regulatory approval by CFDA and product ... chronic gastroesophageal reflux disease (GERD). Continue Reading ... ... Congress of Digestive Endoscopy, by Professor Jun Liu, Director of Endoscopy at Wuhan Union ... "We are very pleased that Mederi products are ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... December 08, 2016 , ... ... from offices headquartered in Jefferson County, is announcing the launch of a charity ... , The number of homeless women and children in Birmingham has grown steadily ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Compretta Insurance Agency, a ... clients in and around the Hancock County area, is announcing the launch of a ... Pantry. , The Hancock County Food Pantry has worked for more than 30 years ...
(Date:12/7/2016)... ... 2016 , ... DrugDev again demonstrated its dedication to reducing the ... early adopters completing EU-U.S. Privacy Shield Certification from the U.S. Department of Commerce. ... of the Atlantic with a mechanism to comply with EU data protection requirements when ...
(Date:12/7/2016)... ... 07, 2016 , ... Kenall Manufacturing, a leader in sealed healthcare lighting for ... is a multi-function, sealed, LED luminaire that meets the needs of everyone in the ... needed. , A 2’ x 4’ model features four modes: reading, ambient, ...
(Date:12/7/2016)... ... December 07, 2016 , ... Wavelink, an industry ... Control through a new partnership with Splashtop Inc. This remote control for Android ... to help businesses maximize their uptime and productivity. , Wavelink offers powerful enterprise ...
Breaking Medicine News(10 mins):