FDA Gets Set for Flu Season with Approval of Vaccines for 2011-12
CDC recommends everyone aged 6 months and older get vaccination
July 19, 2011
As senior citizens suffer through a blistering hot summer, the U.S. Food and Drug Administration is finalizing plans for the flu season
around the corner. Yesterday the agency approved the influenza vaccine to be made for 2011-2012 by all six manufacturers licensed to produce
and distribute flu vaccine for the U.S.
Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by influenza
viruses. 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.
On average, 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 FDAs 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 CDCs 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.
CDC Says Everyone Aged 6 Months or Older Should Get
Flu Vaccination
An advisory panel to the Centers for Disease
Control and Prevention (CDC)of immunization experts voted on February 24, 2010 to expand the recommendation for annual influenza vaccination
to include all people aged 6 months and older.
The expanded recommendation took effect in the 2010 2011 influenza season. The new
recommendation seeks to remove barriers to influenza immunization and signals the importance of preventing influenza across the entire
population.
These recommendations of the ACIP became recommendations of CDC when they were accepted by the director of CDC and the Secretary
of Health and Human Services and published in the Morbidity and Mortality Weekly Report.
Based on that information and the recommendations of the FDAs 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, according to the FDA. 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.
CDCs ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination.
Note: The FDA, an agency within the U.S. Department of Health and Human Services, says it 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 nations food supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
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