Girl dies after cervical cancer vaccine

LONDON - September 29, 2009 Natalie Morton died in a hospital Monday, a few hours after being the given the Cervarix vaccine, which protects against two strains of the human papilloma virus that causes cervical cancer.

There are no indications of any link between Morton's death and the vaccine - administered at her school in Coventry - although Morton appeared to be healthy before being given the shot. An autopsy will be carried out to determine a cause of death.

Meanwhile, the U.S. Food and Drug Administration has delayed a decision on whether to approve Cervarix. A decision on the vaccine was expected Tuesday. But GlaxoSmithKline UK, which manufactures Cervarix, said the death in Britain did not influence the FDA's decision to extend its review.

The National Health Service in Coventry said it stopped the vaccination program for two days to give staff administering the vaccine training in how to answer questions from anyone concerned about its safety.

"We fully expect to resume the program in the coming days," the health authority said in a statement.

Morton fell ill at the school and later died, according to Caron Grainger, the director for public health at Coventry City Council. The vaccine consists of three injections given over a six-month period, and it had been Morton's first shot. The council declined to give any further details of the death.

Health officials also said they quarantined the batch of vaccine given at the school. The school principal, Julie Roberts, said a few other girls also reported being unwell after receiving the vaccine and some were sent home.

The state-run National Health Service began offering the Cervarix vaccine to teenage girls last year, and more than 1.4 million doses of the vaccine have been given out so far under the program. The virus is often transmitted through sexual intercourse and authorities wanted to give the vaccine to girls as young as 13 so they are protected by the time they become sexually active.

The cervical cancer vaccine is routinely administered to millions of young girls across Europe and North America. No safety concerns about the vaccines have been raised elsewhere.

"As with any medical intervention ... one can, on rare occasions, see tragic consequences," said Professor Malcolm McCrae, virologist at the University of Warwick. "But overall this is an extremely well tested vaccine which has been produced in response to a critical health issue - cervical cancer - a disease responsible for almost 1,000 deaths annually in the UK."

Dr. Pim Kon, medical director at GlaxoSmithKline UK, said in a statement that the company is working with the Health Department and health regulators to investigate the case and that the exact cause of death was not yet known.

The statement added that the majority of suspected adverse reaction to the Ceravix vaccine so far have related "either to the signs and symptoms of recognized side effects listed in the product information or were due to the injection process and not the vaccine itself."

GlaxoSmithKline shares were down 0.68 percent at 1,243 pence ($19.78) on the London Stock Exchange late Tuesday. The cervical cancer vaccination program sparked controversy in Britain when it was first introduced. Some critics argued it would encourage girls to become sexually active at a younger age.

Morton's death comes as doctors begin to give children a vaccine against swine flu in a clinical trial. Doctors across England have begun administering one of two vaccines to 1,000 children between the ages of six months and 12 years. One of the vaccines is administered by GlaxoSmithKline and the other by Baxter. The trial aims to see which one is most effective on children.

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