# 4400
Before you skip past what sounds like it will be a boring and routine report . . . read on.
There’s some news to be had here.
Aside from recommending nearly universal flu vaccinations (just about everyone over the age of 6 mos.), ACIP (Advisory Committee on Immunization Practices) has announced the availability of a high dose flu vaccine for the 2010-11 season for those over the age of 65.
One of the concerns about the flu vaccine has been the less robust immune response in those (traditionally) most at risk from influenza – the elderly.
While a healthy adult under the age of 65 may see a 70%-90% level of protection from a well-matched flu vaccine, those over the age of 65 often see far less.
A few choice blogs on this topic include:
Another Study: Flu Vaccines Do Not Reduce Mortality Rates In The Elderly
Study: Flu Vaccines And The Elderly
Roughly 18 months ago we learned (see Vaccines: Sometimes You Just Need A Bigger Hammer) of a study conducted by Sanofi-Pasteur where several thousand people over the age of 65 were given a flu vaccine with 4 times the antigen of a standard shot.
Instead of 15ug of antigen per strain, these shots contained 60ug.
Those who received the stronger shot developed a significantly stronger immune response than those who received the standard dose.
The FDA approved the use of Sanofi’s High Dose Fluzone last December.
FDA PRESS RELEASE
For Immediate Release: Dec. 23, 2009
Accelerated approval process used in vaccine approval
The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.
People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.
ACIP has not expressed a preference for the new High Dose Fluzone for those over 65, so eligible recipients should discuss that option with their personal physician.
It will likely take a year or more before scientists can assess the impact of this higher dose flu vaccine.
Here then are the Provisional recommendations for the upcoming flu season, released yesterday.
ACIP Provisional Recommendations for the Use of Influenza Vaccines
Date of ACIP vote: February 24, 2010 Date of posting of provisional recommendations: March 2, 2010
Tentative date of publication of recommendations in CDC Morbidity and Mortality Weekly Report: June 2010
On February 24, 2010, the ACIP voted on updated recommendations for use of trivalent seasonal influenza vaccine for the 2010-2011 influenza season.
Provisional recommendations for the prevention and control of seasonal influenza (2010-2011 influenza season):
Vaccination recommendations for adults were expanded to include all adults beginning in the 2010-11 influenza season.Therefore, all people age 6 months and older are now recommended to receive annual influenza vaccination.
Background information on influenza vaccines•The 2010–2011 trivalent vaccines will contain A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens. Compared to the 2009-10 Northern Hemisphere influenza vaccine, the influenza A(H1N1) and A(H3N2) strains are changed. The A/California/7/2009 (H1N1)-like strain is the same strain that was included in the pandemic influenza A(H1N1) 2009 monovalent vaccines.
•A higher dose formulation of an inactivated seasonal influenza vaccine (Fluzone High-Dose, manufactured by sanofi pasteur, licensed by FDA on December 23, 2009) for use in people age 65 years and older will be available in the 2010-11 influenza season.∗ Fluzone High-Dose contains four times the amount of influenza antigen compared to other inactivated seasonal influenza vaccines. Fluzone High-Dose vaccine in one study of people age 65 years and older produced higher antibody levels, but slightly higher frequency of local reactions. Studies are underway to assess the relative effectiveness of Fluzone High-Dose compared to standard dose inactivated influenza vaccine, but results from those studies will not be available before the 2010-11 influenza season. The ACIP has not expressed a preference for Fluzone High-Dose or any other licensed inactivated influenza vaccine for use in people age 65 and older.
•An additional inactivated vaccine (Agriflu, manufactured by Novartis, licensed by FDA on November 27, 2009) will be available in the 2010-11 influenza season.† Agriflu is licensed for use in people age 18 years and older.
•Age indications for two inactivated influenza vaccines have changed. Afluria, manufactured by CSL Vaccines, is now licensed for use in people age 6 months and older. Fluarix, manufactured by GSK Biologicals, is now licensed for use in people age 3 years and older.
∗ Fluzone High-Dose has been licensed by FDA, but will not be available until the 2010-11 influenza season.
† Agriflu has been licensed by FDA, but will not be available until the 2010-11 influenza season.
