Fatality reported in UK HPV vaccine immunisation programme

Tuesday 29 September, London UK

GSK was notified by the UK’s Department of Health on Monday 28 September of the death of a 14 year old girl, Natalie Morton, who was vaccinated at a school in Coventry with GSK’s cervical cancer vaccine, Cervarix, as part of the national HPV immunisation programme.

Dr Pim Kon, Medical Director, GlaxoSmithKline UK said: “Our deepest sympathies are with the family and friends of the young girl.

“At this stage the cause of this tragic death is unknown. Following immediate quarantine of the batch involved last night, we have 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.

“We are liaising with the authorities to ensure that all healthcare professionals and school nurses are made aware of this action.

“GSK will continue to work closely with the Department of Health and MHRA and do everything we can to support the investigation.”

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.

More than 1.4 million doses of Cervarix have been given as part of the national immunisation programme in the UK.

To date the vast majority of suspected adverse reactions reported to MHRA in association with Cervarix vaccine have related either to the signs and symptoms of recognised side effects listed in the product information or were due to the injection process and not the vaccine itself.

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