Merck plant cited for violations: some resolve while other problems continue

Merck Pharmaceuticals, the maker of Gardasil has been cited with warning letters from the Food and Drug Administration as far back as 2008 stating that the West Point, Pennsylvania plant has sub par manufacturing practices that could have resulted in quality problems among the vaccines produced in the plant.  The letter, which brings out what is called 49 Form 483 observations is sent only after repeated attempts to have a company address issues have been made, but has yet to produce the desired results.  If the company had not already “failed” inspection and would have made the required changes, the letter would never have been necessary.  

The letter focuses specifically on manufacturing concerns and states that more than once Merck has failed to check dosage strengths on batches of vaccine prior to distribution and they cite multiple incidences in the manufacture of the measles, mumps  and rubella vaccine (MMR) that they produce. Merck representatives claim that while a portion of the FDA’s concerns have been “closed out” there are still a few points that continue to be reviewed, including changes to Gardasil’s packaging to state that the vaccine is appropriate for women ages 27-45. Gardasil is currently recommended for women and girls ages 9-26 to prevent certain strains of the human papilloma virus which can cause both genital warts and cervical cancer.  Health officials estimate that between 30%-40% of young women will contract HPV by their 20’s.

Gardasil was approved for use in 2004, and since its release women have been stricken with a variety of disabling symptoms.  12 year old Savanna took her vaccine on a routine trip to the physician for a yearly check up and after the second vaccine found herself making trips to the hospital for treatment of vision loss, brain fog, twitching, weakness, trouble breathing and a host of other complications that slowly took her freedom and childhood from her.  Merck has made some minor adjustments to the information regarding Gardasil’s side effects to include fatigue, weakness and muscle pain but these symptoms simply do not begin to scratch the surface of the many dangerous and even deadly complications from the shot.

Gardasil has been linked to at least 18 deaths, four from blood clots.  Each year the United State’s VAERS system– an automated database that collects information on possible vaccine reactions has taken thousands of reports about suspected reactions to Gardasil that include everything from muscle weakness, ALS (Lou Gehrig’s disease), fainting, seizures and even death.

Research now shows that only 1/3 of all women and girls who start the series ever complete the full vaccination, and Merck is going to be stepping up an aggressive marketing campaign in weeks to come to help boost sagging sales for the drug, and are also turning their focus to boys in an attempt to reduce the rates of anal cancer among young men.  The company’s slogan “One Less” has been turned around by Gardasil opponents to be “one less child to suffer the damage” of this potentially deadly immunization.


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