Ceravix Suspected Death of 14-Year-Old in UK

Natalie Morton

The Wall Street Journal is reporting that drug maker, GlaxoSmithKline PLC (GSKLN) has been notified that a 14-year-old girl, Natalie Morton, died shortly after being vaccinated with the cervical cancer vaccine, Cervarix.

The Guardian takes the story a bit further.

The paper says an urgent investigation is underway and that the girl was a student at Blue Coat Church of England School in Coventry. She reportedly got the vaccination at school Monday and didn't feel well right after the “jab” as it’s called in Britain.

Morton was taken to Coventry University hospital and died at lunchtime.

There is no exact cause of death determined, but an autopsy is being conducted. As a precaution GSK has quarantined the batch of vaccine that was used.

A letter went out to parents posted on the school Web site that Morton has suffered a “rare but extreme reaction.” Other girls who also got the vaccine on the same day were reported to feel dizzy and nauseous with symptoms described as mild.

GSK says in a news release it is supporting an investigation and working closely with the Department of Health. “The batch being recalled is AHPVA043BB, which will be tested as part of the investigation. Other batches of the vaccine remain available and are not affected by this recall,” says Dr. Pim Kon, the company’s medical director.

National Immunization Program

In Britain there is a nationwide immunization program against HPV that targets young females before they are sexually active. The goal is to have all girls under the age of 18 vaccinated by the year 2011.

Earlier this month, an FDA advisory panel met to consider the approval of Cervarix in the U.S.

Britain uses Cervarix rather than Merck’s Gardasil. In July a study published in July issue of The Lancet found Cervarix was effective against five viruses, as opposed to four covered by Gardasil.

The BBC reports that there were 1.3 million girls vaccinated in Britain with the health department reporting 4,657 suspected reactions, most of them mild and no other deaths, while cervical cancer kills 1,000 women a year.

Public health officials are telling the public not to panic. The U.K. regulatory agency has collected numerous reports on reactions. Glaxo says most are recognized side effects from injection and are not from the vaccine. There have been no deaths reported.

Adjuvants

With all of the news about the development of many new swine flu vaccines comes more information about “adjuvants” or vaccine boosters. The emerging science is just being understood and only aluminum containing adjuvants are used in U.S. licensed vaccines, reports the FDA.

Cervarix contains adjuvants, reports GSK “to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing HPV types, although the exact level of antibodies that confer protection is not known.”

Adjuvants are not licensed separately from the vaccine that contains them. #