Navigation Links
FDA Approves Vaccines for the 2010-2011 Influenza Season
Date:7/30/2010

SILVER SPRING, Md., July 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.

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

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

Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic. Last year because the 2009 H1N1 virus emerged after production began on the seasonal vaccine,  two separate vaccines were needed to protect against seasonal flu and the 2009 H1N1 pandemic flu virus, but this year, only one vaccine is necessary.

According to the Centers for Disease Control and Prevention (CDC), between 5 and 20 percent of the U.S. population develops influenza each year, leading to more than 200,000 hospitalizations from related complications and about 36,000 deaths.

"The best way to protect yourself and your family against influenza is to get vaccinated every year," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death."

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 important to protect themselves, their patients, their family, and the community from influenza. FDA urges health care organizations to encourage their members to get vaccinated.

The brand names and manufacturers for the upcoming season's vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

Each year, experts from FDA, World Health Organization, CDC, and other institutions study virus samples and patterns collected worldwide to identify strains likely to cause the most illness during the upcoming season.

Based on that information and the recommendations of FDA's Vaccines and Related Biological Products Advisory Committee, manufacturers included the respective three strains in the 2010-2011 vaccines. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against influenza disease.

Vaccines for the 2010-2011 seasonal influenza contain the following strains:

  • 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.

Seasonal influenza vaccines have a long and successful track record of safety and effectiveness in the United States.

The labeling for one vaccine, CSL Limited's Afluria, has undergone changes this season to inform health care providers about an increased incidence of fever and febrile seizure, which was seen in young children, mainly those younger than 5 years, following administration of the 2010 Southern Hemisphere formulation of CSL's influenza vaccine. The Southern Hemisphere influenza season occurs prior to that of the Northern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere.

The Centers for Disease Control and Prevention has published recommendations for annual influenza vaccination to include all people aged 6 months and older. The expanded recommendation is to take effect in the 2010-2011 influenza season. The Advisory Committee on Immunization Practices (ACIP), which advises the CDC on vaccine issues, voted on the new recommendation during its February 24, 2010 meeting in Atlanta. Prior recommendations for seasonal influenza vaccination focused on vaccination of persons at increased risk for complications from influenza including people with underlying health conditions, children 6 months through 18 years of age, and close contacts of high risk persons among others.  The new recommendations can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0729a1.htm.

For more information:

FDA Web Page on Influenza Vaccine Safety & Availability

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

FDA List of Strains Included in the 2010-2011 Influenza Vaccine

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm202750.htm

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza

http://www.cdc.gov/flu/

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 Strativa Pharmaceuticals Zuplenz® (ondansetron) Oral Soluble Film
2. FDA Approves Sagent Pharmaceuticals Heparin Sodium Injection, USP
3. U.S. FDA Approves Improved Performance of Riverain Medicals OnGuard Chest X-ray Computer-Aided Detection Technology
4. FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women
5. FDA Approves New Treatment for Late-Onset Pompe Disease
6. FDA Approves Cefepime for Use In B. Brauns DUPLEX(R) System
7. U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
8. FDA Approves New Combination Product Oral Contraceptive
9. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
10. FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer
11. FDA Approves New Device for Adults with Severe and Persistent Asthma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)... , June 24, 2016 VolitionRx ... of Dr. Edward Futcher to the ... effective June 23, 2016.Dr. Futcher was also appointed ... Governance Committees.  As a non-executive member of the ... and strategic counsel to VolitionRx in connection with ...
Breaking Medicine Technology:
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
Breaking Medicine News(10 mins):