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Merck responds to Gardasil safety questions
09 Jul 2008
Regulatory Affairs
Merck today issued a statement about reported adverse events concerning its cervical cancer vaccine Gardasil.
The company said it believes there is no safety issue with the medicine, having analysed relevant data in response to reports of death and paralysis.
It concluded the reported events could be seen in the general population, even in the absence of vaccination, adding that the vast majority of adverse events were non-serious.
Richard M Haupt, executive director of clinical research at Merck Research Laboratories, said "we remain confident in the safety profile of Gardasil".
He also encouraged patients and healthcare providers to report any adverse experiences associated with the vaccine to Merck and the US Vaccine Adverse Event Reporting System so the safety of the "important vaccine" can continue to be monitored.
Last month, Merck said the US Food and Drug Administration (FDA) had completed a review and stated there were issues precluding approval of the supplementary licensing of the product within expected timeframes for use in women aged 27 to 45.
It added the FDA's decision did not affect current use of the vaccine in females aged between nine and 26.
