Schoolgirl’s Death After Cervarix HPV Shot Raises Questions about Screening for Underlying Medical Conditions

Britain’s HPV vaccination program was suspended yesterday and a 200,000-shot batch of Cervarix was recalled after 14-year old Natalie Morton turned pale and collapsed after being vaccinated. She died in hospital just hours later.

Because of the implications of her death, an autopsy was performed very quickly at University Hospital in Coventry, England. Initial results indicate that Ms. Morton’s death was a result of an "underlying medical condition," although no explanation was given as to why the shot apparently—although not definitely—precipitated Ms. Morton’s death.

Questions about rare adverse events associated with both Cervarix and Gardasil frequently center on the difference between causality and the trigger effect. Both Cervarix and Gardasil, for instance, have been associated with autoimmune diseases, which arise in genetically predisposed individuals but require an environmental trigger such as chemical exposure or a vaccination.

Take fifteen year old Jenny Tetlock, who apparently had a predisposition to autoimmune disease as seen in an early childhood skin condition. She died within two years of onset of a very rapidly progressing ALS-like paralysis that began shortly after vaccination with Gardasil; the autopsy showed that she had damage to her spine that was caused by “neurological disease that was mediated by immune responses.”

Although no definitive link with Gardasil has been made, the question still looms large in the minds of concerned scientists, doctors and parents—even if Gardasil didn’t definitively “cause” Ms. Tetlock’s death, did it trigger it? And if so, how do we stop that from happening again? Can we, and should we, insist on a better screening process to find individuals likely to be adversely affected by immunization?

The VAERS passive surveillance system reports eleven cases of cardiac arrest after vaccination with Gardasil. The Advisory Committee on Immunization Practices recommended back in 2003 that military personnel with known underlying heart disease or cardiac risk factors, such as diabetes or a smoking habit, should NOT be given the smallpox vaccine after it was associated with increased cardiac “events.”

And the FDA has found a slightly increased risk of blood clots to be associated with Gardasil, which should raise questions for girls who are on the Pill; and when two girls in Spain suffered repeated convulsions for months after being given the vaccine, an investigation found that the convulsions weren’t caused by Gardasil but could have been triggered by it.

Meanwhile, Dr Caron Grainger, joint director for public health for the National Health Service Coventry and Coventry city council, simply said in a statement: “The preliminary postmortem results have revealed a serious underlying medical condition which was likely to have caused death. We are awaiting further test results which will take some time. However indications are that it was most unlikely that the HPV vaccination was the cause of death.”

NHS officials urged parents not to be alarmed and to allow their children to be vaccinated when the Cervarix program resumes next week. Girls aged 12 and 13 in British schools are given the HPV jab in school unless their parents specifically object. The batch of Cervarix that was used for Natalie Morton’s vaccination has been returned to GlaxoSmithKline for further testing, and schools are awaiting fresh supplies.

Cervarix and Gardasil are both new vaccines against the human papillomavirus, which is usually shrugged off by the immune system but can, in a very tiny percentage of cases, cause cervical cancer and (even more rarely) penile, esophageal, anal or testicular cancer. The vaccines use genetically engineered VLPs (virus-like particles); Cervarix protects against two oncogenic strains of HPV and uses a novel adjuvant, AS04; while Gardasil uses an aluminum adjuvant and protects against two oncogenic strains and two genital wart-causing strains.

Vaccination programs usually work on the “greater good” principle, with the idea that a few patients might experience adverse side effects, even death, but lives will be saved overall. Merck has been widely criticized for its heavy-handed over-selling of Gardasil, notably in last month’s JAMA.

What do you think? Could we do a better job of screening individuals prior to vaccination rather than adopting a “one size fits all” policy?