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Feds OK New Version Of Inhalable Flu Vaccine

Vaccine Can Be Refrigerated Instead Of Frozen

POSTED: Monday, January 8, 2007

The government has cleared a new version of the inhalable flu vaccine that can be refrigerated instead of being stored frozen.

That should make it easier to handle for some schools, stores and pharmacies, where the requirement that the original version of the vaccine be kept frozen presented difficulties, according to its manufacturer, MedImmune Inc., of Gaithersburg, Md.

The new version on FluMist is expected to be available in August, in time for the 2007-2008 flu season.

The nasal spray delivers weakened live viruses to patients.

The Food and Drug Administration originally approved FluMist in 2003.

FluMist is approved for healthy people ages 5 to 49, though the company seeks expanded approval for use in children as young as 1 as long as they don't have a history of wheezing or asthma.

MedImmune said the new formulation should be available in August, in time for the 2007-2008 flu season.

The FDA said that studies with FluMist did not include enough patients over the age of 49 to determine if they respond differently than younger individuals, which is why the "safe and effective use of FluMist in persons 50 years and older has not been established."

Children 5-8 years old need two doses at least six weeks apart in their first year of vaccination with FluMist, according to the FDA, and people ages 9-49 years old need only one dose.

There are some side affects associated with use of FluMist. The most common include: nasal congestion, runny nose, sore throat, headache, irritability, decreased activity, muscle ache and cough.

The FDA recommends that flu vaccines be administered prior to exposure to influenza. The peak of influenza activity varies from year to year but generally occurs in the U.S. between late December and early March. Influenza vaccines usually become available in early October, but contact your health-care provider for additional information.

And FluMist is not a one-time-only vaccine. The FDA recommends annual revaccination with FluMist because yearly variation in the influenza strains is possible.

Certain People Should Not Receive FluMist

The FDA said that all individuals should check with their health care provider before receiving any flu vaccines. According to the approved package insert, the following people should not get the intranasal influenza vaccine:

  • Adults 50 years of age or older, or children younger than 5 should not receive FluMist.
  • FluMist should not be given for any reason to people with immune suppression. This includes people with primary immune deficiency diseases, as well as people with immune deficiencies related to HIV infection, cancer, or other conditions, and people who are being treated with drugs that cause immunosuppression.
  • The safety of FluMist in people with asthma or other reactive airway diseases has not been established, and therefore, is not recommended for use in patients with a history of reactive airway problems.
  • Additionally, FluMist should not be given to people with chronic underlying medical conditions that may predispose them to severe flu infections. For these people, the injected vaccine is indicated.
  • Individuals with egg allergies should not receive this or any other flu vaccine without first consulting their physicians.
  • People who have health problems associated with heart disease, kidney disease, lung disease, or metabolic diseases such as diabetes, anemia and other blood disorders should not receive FluMist.
  • Because Reye syndrome in children has been associated with administration of aspirin during influenza virus infections, FluMist is not recommended in children and adolescents 5-17 years of age if they are receiving aspirin or aspirin-containing therapy.
  • Pregnant women should not receive FluMist.
  • Anyone with a history of Guillain-Barre Syndrome (GBS) should not receive FluMist.
  • FluMist recipients should avoid close contact (e.g., within the same household) with anyone with a weakened immune system for at least 21 days after receiving the vaccine.

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