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:2/18/2017)... , Feb. 17, 2017   ... to protecting the rights of victims injured by ... prompted regulators to call for better reporting. Congress ... Safety concerns involving power morcellators and ... (FDA) to investigate how hospitals report injuries and ...
(Date:2/17/2017)... According to a new market research report ... Application (Cleanroom Monitoring, Contamination Monitoring of Liquids), and End User (Healthcare ... the market is expected to reach USD 330.6 Million by 2021 ... from 2016 to 2021. Continue Reading ... ...
(Date:2/17/2017)... 17, 2017 Research and Markets has announced the ... report to their offering. ... report provides separate comprehensive analytics for the US, Canada ... Asia-Pacific , Latin America , and Rest ... through 2022. Also, a six-year historic analysis is provided for these markets. ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... February 17, 2017 , ... ... sustainable systems change designed to further positively impact the health and wellness of ... has long considered it our duty to seriously consider releasing our assets beyond ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... Prevent a Warning Letter, **An FDAnews Webinar**, Feb. 23, 2017 — 1:30 p.m. ... distinguish between corrective action (CA) and preventive action (PA)? , The methods share ...
(Date:2/17/2017)... , ... February 17, 2017 , ... ... operations executives and focusing on all facets of clinical trial planning and management. ... , patient engagement, and more. In addition, attendees stopping by Pharmica’s booth were ...
(Date:2/17/2017)... ... February 17, 2017 , ... The Mason Pasquin Agency, ... and business owners in and around the Hampton Roads metropolitan region, is joining ... forms of domestic violence. , There are multiple categories of domestic violence – ...
(Date:2/16/2017)... AL (PRWEB) , ... February 17, 2017 , ... ... protection assistance and financial planning services to families and entrepreneurs in the Birmingham ... a local adoptive mother who needs assistance with her medically challenged son, Anius. ...
Breaking Medicine News(10 mins):