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.
January 30th, 2010 at 9:19 am
40 hours after our 17 year old daughter,jessica ericzon got her third Gardasil shot she died instantly. side effects written off by her doctor as growing pains led up to her heart stopping. the coroner said she was dead before she hit the floor. there are no tests to prove Gardasil is killing and making thousands of girls sick all over the world. Jessica’s autopsy report lists cause unknown. she was an all-star athlete and honor student. never ever had any health issues. she was young, vibrant and full of life. not anymore. Merck killed her with the Gardasil vaccine.the FDA and CDC bought out by big pharma. using the general population as lab rats and when things go wrong,hey just another guinea pig dead. no big deal right. well—-it is a BIG DEAL and there are a lot of people out there waiting and watching for justice. talking to insiders,collecting info,documenting track records and demanding action.,asking questions knowone else dares or cares to. Lookout Merck we are coming for you.
May 10th, 2010 at 6:16 am
In a country as large as ours it is amazing to me that we let greed take over common sense. Does Merck think all of these people are making this stuff up? No, they don’t care. All that is important is the mighty dollar. I hope that this all comes back three-fold on those involved. Watching my granddaughter I would not wish the side-effects from this drug on any living creature. At 19, her hopes and dreams have been taken. She is completely disabled unless a miracle occurs. I really strongly hope those involved in making and administering the drug will answer for their greed to their higher power for eternity.