HPV Vaccine Batch Recalled While Investigation Underway

Published: 30-Sep-2009

MHRA stated: 'no link can currently be made between the girl’s death and the vaccine'

The Medicines and Healthcare products Regulatory Agency (MHRA) has 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 have being asked to return any unused stock of this batch to GSK.

However, MHRA has stated that 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.

Mr Woods, said: “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.

“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,” added Mr Woods.

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