September 29, 2009

expert reaction to the death of a teenage girl following a dose of Cervarix

The girl, aged 14, died after receiving the cervarix vaccine, which protects against the human papilloma virus (HPV), the cause of a large number of cases of cervical cancer. So far, however, no link has been proved between the two events.

Prof Malcolm McCrae, virologist at the University of Warwick, said:

“As with any medical intervention, vaccines are no different in that sense that one can, on rare occasions, see tragic consequences. But overall this is an extremely well tested vaccine which has been produced in response to a critical health issue – cervical cancer, a disease responsible for almost one thousand deaths annually in the UK.”

Dr David Elliman, Consultant In Community Child Health at Great Ormond Street Hospital For Children, has prepared the following Q&A: On 28th September 2009, a 14 year old girl in Coventry died some hours after receiving a dose of Cervarix vaccine. No other details are known at this stage (morning of 29th September). Understandably, parents and girls may have some concerns and the following Q&A is designed to help address these. Cervarix vaccine prevents infection with the two commonest types of HPV involved in cervical cancer. Even with the cervical screening programme, in England, each year, there are •,21,617 cases of advanced precancerous disease •,2,221 cases of invasive cancer of the cervix •,899 deaths from cancer of the cervix. The vaccine will probably prevent in the order of 70% of these. The vaccine has been used in this country for just over a year and well over a million doses have been given. Worldwide many more doses have been administered with a good safety record. QUESTIONS AND ANSWERS Q. What happened? A. All we know at this stage is that a 14 year old girl, tragically died the same day as she was given the vaccine. We do not know her past medical history and a post-mortem has yet to be held to ascertain the cause of death. Q. Is her death linked to the vaccine? A. It is impossible to say until further investigations have taken place, but it may have been a coincidence. Unfortunately, some young people do die suddenly for a variety of reasons, including cardiac causes. Sometimes they have been entirely well until their death. Q. Is the vaccine safe? A. Extensive safety studies were performed prior to the introduction of the vaccine, but they may not have picked up very rare events. However since the vaccine was introduced (it is now licensed in over 90 countries), its safety has been monitored very carefully. In spite of millions of doses being given, we are not aware of any similar occurrence previously. Rarely, a person does have a life threatening allergic reaction after a vaccine, medicine or food. This is very rarely fatal after a vaccine. Q. Could there be a problem with a particular batch of vaccine? A. Until we know more, this is impossible to say, however, as a precaution, the batch from which this young girl was immunised (AHPVA043BB) has been quarantined and should not be used until further notice. It should not be discarded. No other significant problems have been reported with this batch. Q. What if I/my daughter has already had a dose from this batch? A. Even in the unlikely event that the tragic death was related to the vaccine, you can be reassured that any similar reaction would be apparent by now. You have no need to be concerned. Q. Should we go on using the vaccine? A. Other batches of the vaccine can be used. The worldwide track record of the safety of this vaccine is such that, it is most unlikely that there is any problem with the vaccine in general. Q. Why do we use Cervarix rather than Gardasil? A. Apart from the fact that Gardasil protects against most forms of warts, there is little significant difference between the vaccines and no difference in safety. However, Cervarix was cheaper and the savings made have allowed about 300,000 more girls to receive the vaccine, than if Gardasil had been chosen. Q. What next? A. As and when more facts emerge, the Department of Health and the regulatory body (MHRA) will be offering further advice. In the meantime, the programme should continue unchanged, with the exception that the batch in question should not be used.