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FDA Approves 2010-2011 Flu Vaccines

 

 

 

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With the US flu vaccination season nearly upon us, the FDA announced yesterday the approval of the following vaccines for use in the United States during the 2010-11 flu season:

 

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

Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

 


These vaccines all combine the 2009 pandemic strain with two other flu strains expected this fall.

 

Specifically:

 

  • 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

 

 

Sanofi Pasteur’s Fluzone High-Dose was approved earlier in the year for seniors over the age of 65 who normally don’t get as much protection from flu shots as do younger recipients.

 

This new high-dose flu vaccine contains 4 times the normal amount of antigen; 60 µg of each of the three recommended strains, instead of the normal  15 µg.

 

Studies have indicated a more robust immune response occurs in seniors receiving this higher dose shot (see Flu Shots And The Elderly and  MMWR On High Dose Flu Vaccine For Seniors).

 

In March, ACIP announced that this new formulation would be available along with standard flu shots this fall, but did not announce a preference for one shot over the other. Those interested should discuss this option with their family physician.

 

CSL Limited’s offering, Afluria, is also on the list, but due to the unusually high number of febrile side effects reported in in Australia in children under five, this product will receive new package warnings and will not be distributed in the .25ml single dose syringes normally used for vaccinating young children.

 

This year the CDC is urging nearly-universal vaccination for those over the age of 6 months (see CIDRAP CDC launches universal flu vaccination recommendation).

 

You can read the FDA Press release for more details at the link below:

 

FDA NEWS RELEASE

For Immediate Release:  July 30, 2010
Media Inquires:  Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries:  888-INFO-FDA, OCOD@fda.hhs.gov

FDA Approves Vaccines for the 2010-2011 Influenza Season

The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.

 

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 percent 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.

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