U.K. Program Stalled After Patient Dies Following Cervical Cancer Vaccination

A cervical cancer vaccination program in a British town has been temporarily halted after a 14-year-old girl died just hours after being given a shot of the vaccine Cervarix.

Cervarix is a GlaxoSmithKline drug designed to prevent cervical cancer by controlling common strains of the human papillomavirus (HPV), which causes most cases of cervical cancer and genital warts. HPV is commonly spread through sexual intercourse.

Cervarix competes with Gardasil, the Merck & Co. vaccine that has been associated with dozens of deaths and adverse events in women and young girls who were given the series of three shots. Some Gardasil users also have developed a rare but serious nervous system disorder called Guillain-Barre syndrome.

Cervarix Seeking U.S. Approvals

Cervarix is used in many European nations but is not approved for use in the United States. However, a Food and Drug Administration advisory panel recently recommending approving the vaccine in the U.S. after finding the drug is a safe and effective method for preventing cervical cancer. The FDA is not obligated to follow the recommendations of its advisory panels, but it most often does.

The FDA said it will not meet today’s deadline for deciding whether to approve Cervarix in the U.S., but a ruling could be made in the coming weeks.

British Program Halted After Girl’s Death

The Cervarix vaccination program conducted by the National Health Service in the British town of Coventry was halted after the death of Natalie Morton, who received the vaccination as part of the program at her school, according to an Associated Press report.

Morton reportedly was healthy before getting the vaccine and an autopsy is planned to determine whether her death was caused or associated with Cervarix. A few other girls at the same school also complained of feeling ill after the vaccinations and were sent home to recover, school officials said.

The batch of Cervarix including the dose administered to Morton and the others has been quarantined so officials can examine it for defects, officials said.

More than 1.4 million doses of Cervarix have been administered since the program began last year.

British health officials said they expect to resume the vaccination program in a few days.

“As with any medical intervention … one can, on rare occasions, see tragic consequences,” Professor Malcolm McCrae, virologist at the University of Warwick, told the AP. “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.”

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