HPV Vaccine Batch Recalled While Investigation Underway

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 Sep 2009 - 20:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) today issued a drug alert to the healthcare community advising them of the recall of the human papillomavirus (HPV) vaccination batch quarantined yesterday following the death of a 14-year-old girl.

The recall is being voluntarily carried out by GlaxoSmithKline (GSK), the manufacturer of the HPV vaccine Cervarix, as a precautionary measure while further investigations into the girl's death are conducted by the MHRA.

Healthcare professionals administering the vaccine are being asked to return any unused stock of this batch to GSK.

The safety of the vaccine is not in question and no link can currently be made between the girl's death and the vaccine.

The national HPV vaccination programme will continue as there are no supply issues associated with Cervarix. New stock is readily available.

MHRA Chief Executive, Professor Kent Woods, said the risk/benefit profile for Cervarix remains positive and that the safety and efficacy of the vaccine had been extensively researched in clinical trials before licensing.

"More than 1.4 million doses of HPV vaccine have now been administered in the United Kingdom and there have only been a little more than two thousand reports of adverse reactions.

"This is comparative with what we would normally expect from any vaccination programme and the reports of reaction to Cervarix have been relatively mild, including fever, headache, fatigue, muscle pain, nausea, vomiting and diarrhoea."

Professor Woods said many women's lives will be saved in the future as a direct result of this vaccine.

"More than 3000 women are diagnosed with cervical cancer every year and approximately 1000 women die from it," he said.

"This young girl's death is an absolute tragedy and our condolences go out to her family and friends.

"We are working with the Department of Health and the vaccine manufacturer GSK, and we all wait now for the results of the investigation. As soon as more information is known, we will take the appropriate action as necessary."

If parents or young people are worried about the safety of any vaccine they should speak to a GP or healthcare professional to discuss their concerns, or visit http://www.immunisation.nhs.uk(external link)where they can find more information about all vaccinations routinely given to children and young people.

Source
MHRA