|Will girl's death affect pending FDA decision?|
|By Jude Santos & Wire Reports|
|Monday, 28 September 2009 18:39|
"At this stage the exact cause of this tragic death is unknown," Glaxo medical director Dr. Pim Kon said in a statement.
"As a precautionary measure, the batch of vaccine involved has been quarantined until the situation is fully understood," Kon added.
News of the death comes on the eve of a possible decision by U.S. health regulators on whether to approve Cervarix for sale in the United States. However, the U.S. Food and Drug Administration often lets its expected action dates pass without a decision, or announces a delay.
A small number of other girls at the school reported mild symptoms such as dizziness and nausea but were not admitted to a hospital, health officials said.
GlaxoSmithKline, based in Brentford, Middlesex, said more than 1.4 million doses of Cervarix had been given as part of the national immunization program.
It said adverse reactions reported so far had related to signs and symptoms of recognized side effects, or were due to the injection and not the vaccine itself.
Cervarix is administered in three separate shots over six months.
Should it gain U.S. approval it would compete with Merck & Co's Gardasil, which has been in the market in the United States since 2006 and had sales of $268 million in the second quarter. (Reporting by Michael Holden; additional reporting by Bill Berkrot in New York; Editing by Michael Roddy, Bernard Orr)
On September 9th, FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.
"The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health. At the time she added "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological harm.
The committee voted 12-1 that Cervarix was effective.