Merck's Manufacturing Problems at Gardasil Factory May be Easing, but There Are Still ProblemsAug 4, 2008 | Parker Waichman LLP
Not too long ago, Merck received a Food & Drug Administration (FDA) warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pennsylvania following an inspection that cited 49 Form 483 observations. Among the products made at the plant is the cervical cancer vaccine, Gardasil. During its second-quarter earnings call, Merck reported that the FDA closed out the warning letter that claimed bulk drug substances for many of Merck’s vaccines were adulterated.
“On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process,” Merck CEO Dick Clark said. “Concerning supplements, we have at least two supplements with the FDA concerning Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] and they will move through the [review] process,” he said. Merck states the supplements are for expanded labeling for Gardasil and that it will respond to an FDA complete response letter for the use of the vaccine in women 27–45 years of age.
Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck said 16 million doses have been administered since its approval. Last month, Merck added more possible adverse reactions to Gardasiil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough. Merck doesn't list blood clots as a Gardasil risk, and doesn't warn of adverse reactions with other drugs.
Katherine Davison, 20, suffered a stroke after receiving a second Gardasil injection. Davison began feeling dizzy and developed flu-like symptoms; she lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. "Before the shot I was fine, and there is no reason I should have had a stroke," said Katherine who says she still can't sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily.
Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released last month by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. Fourteen-year-old Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s symptoms began soon after she received her second Gardasil shot and seemed to match many of the 5,000 reports filed through a national database. Recently, 13-year-old Jenny, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; Jenny is now almost completely paralyzed.