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FluMist gets FDA green light

Published on May 15, 2007 at 7:16 PM · No Comments

The Food and Drug Administration (FDA) in the United States says FluMist, an influenza vaccine made by MedImmune appears to be safe for young children even though the influenza vaccine is still under review.

MedImmune is after FDA approval to market the spray for children ages 1 to 5 who have no history of wheezing or asthma; FluMist is already approved for healthy people between 5 and 49 years old.

In four studies conducted by MedImmune the drug was found to be effective against Type A and B influenza viruses; one trial indicated a 90 percent efficacy, according to the FDA.

The FDA says safety concerns associated with the drug appear to be few, however side affects including sore throat, runny nose, and a cough were reported.

Other side effects included pneumonia, among other problems but MedImmune has promised to continue to monitor the drug in younger patients if approved.

When MedImmune's spray was first approved in 2003 it was not popular because it had to be frozen which made it difficult to store and ship.

This updated version, also known as CAIV-T, can be safely kept in a refrigerator.

Posted in: Pharmaceutical News

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