Is a U.K. teen's death a setback for GSK's cervical cancer vaccine?

Just when GlaxoSmithKline (GSK) was set for U.S. Food & Drug Administration approval of its cervical cancer vaccine, tragedy struck in the United Kingdom. Natalie Morton, a 14-year-old British girl, died Monday a few hours after receiving the vaccine, called Cervarix. On Tuesday, the FDA delayed its expected approval.

GSK spokesperson Sarah Alspach told DailyFinance in an e-mailed statement that "the event in the U.K. has not been a factor in the extended review." She noted that "the FDA did not provide a specific timeline" as to when it will reach a decision, but added that "GSK remains confident in the BLA [biologics license application] submission and expects the FDA to complete the review soon."
In the case of Morton, the BBC reported that officials had recently released the results of a preliminary post-mortem examination, which had "revealed a serious underlying medical condition which was likely to have caused death."

Still, this incident has prompted critics of the U.K. immunization program to speak out. No doubt, the debate will spill over to the U.S. because not all doctors agree that the vaccine is needed. For example, Charlotte Haug , editor-in-chief of the Journal of the Norwegian Medical Association, says cervical cancer takes decades to develop and that there are established methods for detecting and treating it.

Just last month, Merck & Co.'s (MRK) cervical cancer vaccine, Gardasil, also captured headlines when it was associated with higher rates of blood clots and fainting, compared with other vaccines. Still, researchers for the U.S. Centers for Disease Control & Prevention and the FDA, writing in the Journal of the American Medical Association, said the drug is safe. They also said there was no evidence that Gardasil caused the severe adverse events -- including several deaths. Instead, certain risk factors were blamed.

In fact, while Gardasil was originally approved in 2006 for girls and women age 9 to 26, on Sept. 9, a U.S. panel also backed expanding the vaccine's use to also prevent genital warts in boys and men age 9 to 26, not to prevent cancer. The FDA now has to decide whether to make that approval.

Similarly, on the same date, an outside panel of health experts also voiced its conclusions on GSK's vaccine, saying the "data provide strong evidence to support the licensure of Cervarix in girls and women 10-25 years of age for the prevention of...cervical cancer." The FDA is not required to follow the group's advice, though it usually does.

Cervarix and Gardasil target strains of human papillomavirus, commonly called HPV, which spreads through sexual contact. HPV infects about 6 million people in the U.S. each year and usually causes no symptoms and goes away. In males, HPV can cause genital warts and penile and anal cancer, much rarer forms of cancer. In women, HPV can cause cervical cancer, which after breast cancer, is the most commonly occurring cancer in women worldwide. Last year, nearly 4,000 women died of cervical cancer in the U.S., accounting for fewer than 1 percent of all cancer deaths.

Cervarix already is approved in more than 95 countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional data. The vaccine blocks the two main strains of the viruses that cause most cases of cervical cancer. Gardasil, however, protects against two more strains.

GSK reacted to Natalie Morton's death, saying in a special statement that "at this stage the cause of this tragic death is unknown." It added that it immediately quarantined the batch of the vaccine and has "taken the decision to voluntarily recall this batch as a further precautionary measure while the investigation into the circumstances surrounding Natalie's death is conducted." GSK will work closely with the investigation, the statement added.

The Telegraph reports UK officials saying that while the incident happened shortly after the girl received the vaccine, "no link can be made between the death and the vaccine until all the facts are known and a postmortem takes place."

So far, more than 1.4 million doses of Cervarix have been given as part of the U.K.'s national immunization program. To date, GSK said, the reactions recorded were the same side effects the product is known for and listed in the product information. If there is a link to the girl's death, it would be the first since the vaccination program commenced last year. As for the possible link, officials added that while waiting further test results, "indications are that it was most unlikely that the HPV vaccination was the cause of death."

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