Issue
Number 581
February 9, 2006
CONTENTS OF THIS ISSUE
- FDA approves new rotavirus vaccine
- FDA approves new lab test for detecting avian influenza
in humans
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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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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 |
