Navigation Links
FDA Approves Vaccines for the 2011-2012 Influenza Season
Date:7/18/2011

SILVER SPRING, Md., July 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by influenza virus strains. The vaccine formulation protects against the three virus strains that surveillance indicates will be most common during the upcoming season and includes the same virus strains used for the 2010-2011 influenza season.

Between 5 percent and 20 percent of the U.S. population develops influenza each year, leading to more than 200,000 hospitalizations from related complications, according to the U.S. Centers for Disease Control and Prevention (CDC). Influenza-related deaths vary yearly, ranging from a low of about 3,000 to a high of 49,000 people.  

"Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research. "It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year."

In addition to the important role that health care providers play in recommending influenza vaccination for their patients, influenza vaccination of health care personnel is also important to protect themselves, their patients, their family, and the community from influenza. The FDA urges health care organizations to encourage their members to follow CDC's Advisory Committee on Immunization Practices (ACIP) recommendations to get vaccinated.

The brand names and manufacturers of the vaccines for the upcoming season are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High-Dose and Fluzone Intradermal, Sanofi Pasteur Inc. Fluzone Intradermal, approved on May 9, 2011, will be available for those ages 18 years through 64 years. This vaccine is delivered into the skin, rather than the muscle, using a very small needle.

Each year, experts from the FDA, World Health Organization, CDC, and others in the public health community study virus samples and patterns collected worldwide to identify virus strains likely to cause the most illness during the upcoming influenza season. Based on that information and the recommendations of the FDA's Vaccines and Related Biological Products Advisory Committee, the strains selected for the 2011-2012 influenza season are:

  • A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
  • A/Perth /16/2009 (H3N2)-like virus
  • B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness.  However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

CDC's ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination. Additional information on the ACIP recommendations can be found at: http://www.cdc.gov/media/pressrel/2010/r100224.htm

For more information:

Cross-Federal Government consumer site for flu information:

www.flu.gov

FDA Web Page on Influenza Vaccine Safety & Availability

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

FDA List of Strains Included in the 2011-2012 Influenza Vaccine

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm262681.htm  

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza                                                                                                   http://www.cdc.gov/flu/

U.S. Centers for Disease Control and Prevention Web Page on Intradermal Influenza (Flu)  Vaccination

http://www.cdc.gov/flu/protect/vaccine/qa_intradermal-vaccine.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
2. FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
3. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
4. FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
5. FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections
6. FDA Approves Nulojix for Kidney Transplant Patients
7. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
8. FDA Approves First Ceramic-on-Metal Total Hip Replacement System
9. FDA Approves Redesigned Labels for Some Merck Drugs
10. FDA Approves Updates to Lillys Humalog® (insulin lispro injection [rDNA origin]) Label
11. FDA Approves Marketing of RMS Subcutaneous Needle Sets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/12/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... it has concluded agreements with the U.S. Department of ... (SEC) to resolve the previously disclosed U.S. Foreign Corrupt ... as in relation to the former deferred prosecution agreement ... with DOJ and SEC, respectively, on March 26, 2012.  ...
(Date:1/12/2017)... 2017  BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical ... findings at this week,s Orlando Dermatology Aesthetic & Clinical (ODAC) ... acnes -induced inflammation. The data will be shared ... Acne Pathogenesis," at ODAC, which is being held Jan. 13-16 ... ...
(Date:1/12/2017)... -- This new report from VPGMarketResearch contains 897 pages, ... German hospital microbiology testing market, including:  ... practice, as well as key economic, regulatory, demographic, social ... next ten years.  ... of major infectious diseases and microorganisms.  ...
Breaking Medicine Technology:
(Date:1/15/2017)... ... January 15, 2017 , ... Going above and ... that strives to better communities around the world by offering the Gensuite team ... the opportunity for team members to become involved in a cause that is ...
(Date:1/15/2017)... CA (PRWEB) , ... January 15, 2017 , ... ... their choice of best physicians in eight Bay Area counties for 2017. Almost ... the healthcare research company managing the award process. Results were announced the magazine’s ...
(Date:1/14/2017)... ... 2017 , ... Healthy living brand Moody Zook recently came ... With more and more people opting to go organic in their lifestyle, the ... to specific needs. , Moody Zook focused particularly on their newly launched activated ...
(Date:1/13/2017)... (PRWEB) , ... January 13, 2017 , ... ... that raise blood sugar levels. Counting carbohydrates is as easy as checking the ... only nutrient that affects blood sugar levels. Despite being sugar-free, proteins can influence ...
(Date:1/13/2017)... ... January 13, 2017 , ... With ... on the challenge of providing additional organic alternatives for customers who have grown ... the brand’s new line of all-natural activated charcoal products, Moody Zook Chief Executive ...
Breaking Medicine News(10 mins):