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Home Industry News MSD responds to Gardasil adverse events queries

MSD responds to Gardasil adverse events queries

9th July 2008

Merck, Sharp and Dohme (MSD) has issued a response to questions about adverse events reported in patients who have been administered with Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, 18] vaccine, recombinant).

The company claims it has analysed the adverse event data relating to reports of paralysis and death and has not identified any safety issue relating to the vaccine.

It added that these type of events could be seen in the general population even without vaccination.

The company said an adverse experience report describes incidents that occur after vaccination but do not attribute cause to this correlation.

Non-serious dizziness and fainting were reported to be the most common adverse effects reported to the company.

Richard M Haupt, executive director of clinical research at Merck Research Laboratories, said: “Merck is proud of the public health benefit that Gardasil can provide in helping to prevent cervical cancer and other HPV diseases caused by HPV types 6, 11, 16 and 18 throughout the world.”

He added the company remains confident in the safety profile of the compound, with the firm encouraging consumers and healthcare providers to report any adverse events related to Gardasil to facilitate safety-monitoring of the vaccine.

In March 2008, MSD reported that Gardasil had been granted priority status in the US.

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