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:12/2/2016)... , December 2, 2016 According ... titled "Global Market Study on Automated Endoscope Reprocessors: Single Basin ... CAGR of 8.6% Between 2016 and 2024 " the global automated endoscope ... is expected to expand at a CAGR of 7.2% during ... of US$ 1,367.6 Mn by 2024. ...
(Date:12/2/2016)... ATLANTA , Dec. 2, 2016 Quantum ... screening and expert radiologist interpretation directly to women at ... partners with corporations, such as Delta Air Lines and ... cancer screening as a component of wellness initiatives. ... women of SunTrust. It enables them to have a ...
(Date:12/2/2016)... , December 2, 2016 ... Awards Committee honored excellence in research, development and innovation ... The gala dinner was held in the presence of ... the Russian Federation , Natalia Sanina, ... Mikhail Murashko , Head of Roszdravnadzor, National Service ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. Vivek ... Dr. Murthy explains how he was inspired to practice medicine at an early age ... is about more than making diagnoses and prescribing medicine,” he states. “It is about ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi Hovsepian, a leading ... the 2016 “Guide to America’s Top Plastic Surgeons” for seven consecutive years. The ... education, experience, and professional associations. , One the most frequently honored surgeons ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite helps biobanks, clinical, research and ... storing, shipping and disposal. The new version is a faster and a more ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... Sourced from ... has some unique properties including its unmatched natural purity of just 6 ppm TDS ... and crisp. , Nothing Water has been available in several ShopRite and FoodTown stores ...
(Date:12/2/2016)... ... December 02, 2016 , ... "Pro3rd Accents Volume 2 is ... create versatile lower third titles with just a few clicks of the mouse," said ... includes 30 lower third animations. Choose from various styles with accented animations, rigid boxes, ...
Breaking Medicine News(10 mins):