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FDA staff note miscarriages in Glaxo vaccine data

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posted on Sep, 5 2009 @ 01:30 PM
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WASHINGTON (Reuters) - A proposed GlaxoSmithKline PLC vaccine helped protect women from the virus that causes cervical cancer but more miscarriages were reported compared with another immunization, U.S. reviewers said in documents released on Friday.

Food and Drug Administration staff said an independent statistical analysis concluded data "do not establish a causal relationship" between the Cervarix vaccine and miscarriages but the findings "were insufficient to rule out a small effect in pregnancies conceived in the three months immediately after vaccination."

FDA reviewers said they will ask an advisory panel that meets Wednesday about the miscarriages and other issues.

Glaxo shares rose 1.2 percent to $39.05 on the New York Stock Exchange.

www.reuters.com...




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