Bloomberg.com: A local U.K. health authority suspended use of GlaxoSmithKline Plc's Cervarix vaccine for cervical cancer and the Department of Health quarantined doses after a 14-year-old girl who received the shot died. Glaxo recalled the batch of vaccine involved in the case.
The girl, Natalie Morton, died yesterday shortly after receiving the vaccine at her school as part of a program to prevent cervical cancer, according to a statement from the National Health Service branch for Coventry, about 100 miles from London. An independent forensic pathologist is conducting an autopsy of the teenager today at University Hospital in Coventry, the NHS agency said.
"No link can be made between the death and the vaccine until all the facts are known and a post mortem takes place," according to the agency's statement. "NHS Coventry has taken the proactive step to quarantine the batch of vaccine being used as a precautionary measure only and has informed the regulatory authority. We are conducting an urgent and full investigation into the events surrounding this tragedy."
Glaxo is recalling the batch "as a further precautionary measure," the company said today in a statement.
Cervarix is cleared in 98 countries and had sales of 125 million pounds ($232 million) last year. That's about one-sixth as much as Gardasil, a rival cancer shot sold by Merck & Co. and Sanofi-Aventis SA. The average estimate of four analysts surveyed by Bloomberg calls for sales worth 882.5 million pounds in 2013.
The U.K. Department of Health asked the NHS to quarantine all stocks of vaccine from the batch related to the case. That may cause delays in vaccination in some areas, the department said in an e-mailed statement. The local NHS branch also won't distribute shots today and tomorrow so that it can prepare its workers to handle any questions they may get about Cervarix.
"We fully expect to resume the program in the coming days," the agency said.
Two Spanish girls suffered seizures and were hospitalized in February after receiving Gardasil. The London-based European Medicines Agency said Gardasil wasn't the likely cause of the seizures and that the shot should continue to be used.
Europe's drug regulator said in February that it received reports of two deaths last year in vaccinated patients, though they weren't conclusively tied to Gardasil. The agency in January recommended a label update for Gardasil highlighting possible side effects, including fainting and erratic movements that resemble seizures.
Support for Investigation
"Glaxo will continue to work closely with the Department of Health and Medicines and Healthcare products Regulatory Agency and do everything we can to support the investigation," London-based Glaxo said in a statement.
No deaths previously have been linked to the cervical cancer vaccine in the U.K., where 1.4 million doses have been given, the London-based Medicines and Healthcare products Regulatory Agency said today. The MHRA is conducting an investigation along with the Department of Health. The most common adverse effects from Cervarix are pain in the extremities, headache, rash, dizziness and fainting, based on more than 2,100 reports to the agency.
"To date, the vast majority of suspected adverse reactions reported to MHRA in association with Cervarix vaccine 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," Glaxo said in a statement.
Gardasil and Cervarix are given in three doses during a six-month period to trigger immune responses that help protect against the two strains of human papillomavirus, HPV, responsible for most U.S. cervical cancer cases. Gardasil also protects against two additional strains of HPV that cause 90 percent of genital warts. Getting immunized costs about $400, and the vaccine is approved for females ages 9 to 26.
The U.S. Food and Drug Administration approved Gardasil in June 2006. Glaxo today said U.S. regulators have delayed the review of its application to sell Cervarix. The delay isn't related to the death of the 14-year-old girl, said Sarah Alspach, a spokeswoman for Glaxo, in a telephone interview today.
In the U.K., about 2,800 women are diagnosed with cervical cancer each year and more than 1,000 die, according to the National Health Service.
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