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Cervarix Batch Recalled Following British Death

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GlaxoSmithKline is recalling one batch of its Cervarix cervical cancer vaccine following the the death of British girl.  However, the company maintains that that incident played no role in the U.S. Food & Drug Administration’s (FDA) to delay making a decision on whether or not to approve  Cervarix  for use in this country.

If approved in the U.S., Cervarix would compete with Merck & Co.’s Gardasil, which the FDA ok’d in 2006.  According to the Associated Press,  the FDA was supposed to announce its Cervarix ruling on Tuesday, but  needed additional data.  Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25.   The vaccine is already approved in 100 other countries.

According to BBC News, a 14-year-old British girl died Monday after receiving Cervarix at school.  She appeared to be healthy prior to receiving the shot, but died in the hospital four hours  later.   The cause of death is unknown at this time, pending an autopsy report. A small number of girls at the school in Coventry had also reported mild symptoms such as dizziness and nausea but were not admitted to hospital.

According to The Wall Street Journal, Glaxo has recalled the batch of Cervarix involved in the fatal incident.  Other batches of the vaccine remain available and are not affected by this recall.   The Cervarix vaccination program in Coventry has been paused for now.

According to the BBC report,  Britain’s Medicines and Healthcare Regulatory Agency has received 2,137 adverse reaction reports involving Cervarix between April 14, 2008 and September 23, 2009.

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