New concerns raised over Merck’s Gardasil

[JohnMack]

Source: PharmaTimes

US public interest group Judicial Watch says it has obtained US Food and Drug Administration documents showing Merck & Co’s new cervical cancer vaccine Gardasil could be linked to as many as 11 deaths since its approval in the market.

[Judicial Watch Press Release]

[Gardasil Related Deaths Reported to VAERS as of Sept. 7, 2007]

The latest data – obtained under the Freedom of Information Act – details 1,824 adverse event reactions following immunisation with the human papillomavirus vaccine, including as many as eight deaths. This adds to 1,637 reports obtained back in May, bringing the total number of deaths to 11.

Among the new information outlined by Judicial Watch is a case involving a 17-year-old female who received a first dose of Gardasil, was found unconscious that evening and subsequently died. A second incident relates to a 12-year-old female with cardiac problems who received a first dose of Gardasil, developed tachycardia and died.

The adverse events have been reported to the FDA via the Vaccine Adverse Event Reporting System. Of the latest batch of adverse events, 347 were deemed serious and included paralysis, Bells Palsy, Guillain-Barre Syndrome and seizures.

“In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls,” said Judicial Watch President Tom Fitton. “These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal.”

A spokesperson from Sanofi Pasteur MSD, the UK licensee for Gardasil, has previously told PharmaTimes World New that such spontaneous adverse event reports show a temporal rather than causal relationship and that the data need to be systematically evaluated before the company and the regulators can make an accurate judgement. He also noted that the dataset filed with regulators contained data on 25,000 women, therefore its safety profile has been well documented, with heart problems and/or blood clotting not listed as potential side effects.

Gardasil headed the charge for Merck’s vaccines unit, contributing $358 million to the unit’s $1 billion sales for the second quarter of the year.