Girls die after cervical cancer jab*
By Rebecca Smith, Medical Editor
Last Updated: 2:55am GMT 25/01/2008
Two girls have died suddenly after being given the vaccine against the
virus which causes cervical cancer, the European drugs watchdog has
revealed.
Gardasil, a Human Papillomavirus vaccine, is displayed at the Girls to
Women Health and Wellness clinic in Dallas
Gardasil, a Human Papillomavirus vaccine
The deaths, in Germany and Austria, came after the women were given the
injections but it is not known how they died or where there was any
connection with the vaccine. All such deaths are recorded by drugs
regulators.
Three women have also died in America after having the vaccine but the
cause of death has not been revealed.
The vaccine, Gardasil, protects against four strains of the human
papillomavirus (HPV), which trigger cancerous tumours and warts.
A vaccination programme will begin in Britain in the autumn with
12-year-old girls getting the jab and older girls being offered it at a
later stage.
It has not yet been decided whether Gardasil, made by Merck and Co, will
be used in the programme or the rival Cervarix, which is made by
GlaxoSmithKline.
The European Medicines Agency (EMEA) said last night: "The EMEA has
received reports of deaths in women who had previously received
Gardasil, including two reports concerning the sudden and unexpected
deaths of two young women in the European Union. 1.5 million patients
have been vaccinated with this HPV vaccine in Europe.
"The two European cases were reported as part of the continuous
monitoring of the safety of medicines. In both cases, the cause of death
could not be identified. No causal relationship has been established
between the deaths of the young women and the administration of Gardasil.
"On the basis of the currently available evidence, the EMEA's committee
for medicinal products for human use is of the opinion that the benefits
of Gardasil continue to outweigh its risks and that no changes to its
product information are necessary."
Monitoring of the vaccine will continue.
Nicholas Kitchin, medical director of Sanofi Pasteur MSD, which
collaborated in the development of Gardasil, said 13 million doses of
the vaccine had been administered worldwide since mid-2006 and it had a
very good safety profile in clinical trials.
He said: "The authorities in Germany and Austria have looked pretty
extensively at these two deaths and have not seen anything that makes
them believe a causal relationship.
"We and the regulators continue to monitor the safety of all our
products and with vaccines it is particularly important because we are
we giving it to healthy people to prevent disease."