“Cervical cancer vaccine likely not cause of death”

Although not directly related to forensic science, this is a topic I’ve heard discussed alot recently amongst parents of girls.  It’s an interesting wee article and I’ll be interested to see what happens in the future regarding uptake of the vaccine in New Zealand – will it be another (unfounded) case of autism-v-vaccination?

“Glaxo’s Vaccine Likely Not Cause of U.K. Teen’s Death

By Kristen Hallam, Bloomberg.com, 29 September 2009.

GlaxoSmithKline’s Cervarix vaccine for cervical cancer was unlikely to have caused the death of a 14-year-old girl, local U.K. health authorities said.

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 [northwest] from London. The Health Service today quarantined the batch of vaccine used in the shot and Glaxo recalled it “as a further precautionary measure,” the company said today in a statement.

Preliminary results of an autopsy performed by an independent forensic pathologist found the teenager had a “serious underlying health condition which was likely to have caused death,” said Caron Grainger, joint director of public health for the NHS Coventry branch and the Coventry City Council, in a statementreleased on the agency’s Web site.  ““We are awaiting further test results which will take some time,” Grainger said in the statement. “However indications are that it was most unlikely that the HPV vaccination was the cause of death.”  Health authorities informed the teenager’s family of the preliminary results of the autopsy, Grainger said in the 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.

Label Update

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.  “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.

Side Effects

“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.”