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Issue Number 581            February 9, 2006

CONTENTS OF THIS ISSUE

  1. FDA approves new rotavirus vaccine
  2. FDA approves new lab test for detecting avian influenza in humans

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(1 of 2)
February 9, 2006
FDA APPROVES NEW ROTAVIRUS VACCINE

On February 3, the Food and Drug Administration (FDA) approved Merck's RotaTeq, a live, oral vaccine for use in preventing rotavirus gastroenteritis in infants and children when caused by the serotypes G1, G2, G3, and G4. The vaccine is intended to be administered as a 3-dose series to infants between the ages of 6 to 32 weeks.

To read the FDA approval information, go to:
http://www.fda.gov/cber/products/rotamer020306.htm

To read the product insert, go to:
http://www.fda.gov/cber/label/rotamer020306LB.pdf

To read questions and answers about the disease and the vaccine, go to: http://www.fda.gov/cber/products/rotamer020306qa.htm

To read an FDA press release about the vaccine, go to:
http://www.fda.gov/bbs/topics/news/2006/NEW01307.html
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(2 of 2)
February 9, 2006
FDA APPROVES NEW LAB TEST FOR DETECTING AVIAN INFLUENZA IN HUMANS

On February 3, CDC published an MMWR Early Release, "New Laboratory Assay for Diagnostic Testing of Avian Influenza A/H5 (Asian Lineage)." Also on February 3, the Food and Drug Administration (FDA) issued a press release on the same topic; a link to the press release is given at the end of this article.

Portions of the Early Release are reprinted below.

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On February 3, 2006, the Food and Drug Administration (FDA) announced clearance of the Influenza A/H5 (Asian Lineage) Virus Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Primer and Probe Set and inactivated virus as a source of positive RNA [ribonucleic acid] control for the in vitro qualitative detection of highly pathogenic influenza A/H5 virus (Asian lineage). Two genetic lineages of influenza A/H5 viruses exist: Eurasian (Asian) and North American. The primer and probe set, developed at CDC, is designed to detect highly pathogenic influenza A/H5 viruses from the Asian lineage associated with recent laboratory-confirmed infections of avian influenza in humans in east Asia and, most recently, in Turkey and Iraq. . . .

Testing with the new assay will be limited to laboratories designated by the Laboratory Response Network (LRN), which consists of approximately 140 U.S. laboratories in 50 states. . . .Influenza A/H5 (Asian lineage) assay protocols and reagents will be distributed by CDC to designated LRN laboratories nationwide during the week of February 6-10, 2006. The real-time RT-PCR primer and probe set is the only laboratory method that has been cleared by FDA for avian influenza A/H5 (Asian lineage) testing and in vitro diagnostic medical device use in the United States. Additional information about the laboratory assay is available at http://www.fda.gov

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To access a web-text (HTML) version of the Early Release, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55e203a1.htm

To access a ready-to-print (PDF) version of it, go to:
http://www.cdc.gov/mmwr/pdf/wk/mm55e203.pdf

To access the FDA press release, go to:
http://www.hhs.gov/news/press/2006pres/20060203.html

 

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This page was updated on February 9, 2006