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Merck Gardasil Vaccine Plant Cited In FDA Warning Letter

May 1, 2008 | Parker Waichman LLP

Merck & Co. has received a warning letter from the Food & Drug Administration (FDA) regarding conditions at the plant where the company makes the cervical cancer vaccine Gardasil, along with several children's vaccines.  Late last year, Merck issued a recall for 1.2 million doses of some pediatric vaccines made at the West Point, Pennsylvania plant cited in the warning letter.

Last week, The Philadelphia Inquirer reported that an FDA inspection of the Merck vaccine plant had uncovered 45 areas of concern, including contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots.   An FDA spokesperson told The Philadelphia Inquirer that the agency sent the letter, dated April 28, because it did not believe the company was moving fast enough to correct past problems.

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008.  The warning letter said the company had failed to ensure that equipment for manufacturing and processing was "calibrated, inspected or checked according to a written program designed to assure proper performance."  The letter also said that in the course of making vaccines, "failures are not fully investigated and documented".

The FDA specifically cited unwanted fibers that were showing up on vial stoppers for such vaccines as MMR, or measles, mumps and rubella. These stoppers are placed in special bags for sterilization. The FDA said the company was using "lesser quality" bags that were breaking down slightly and producing the fibers. The FDA cited Merck for only discarding vaccines where the fibers were found. The company should have assessed all potentially affected products, the FDA said.

In December, Merck recalled over 1.2 million doses of defective vaccines—11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine—when quality control checks revealed production equipment might not have been properly sterilized.  Merck also quarantined a nearly one-year supply of other potentially suspect doses.  Vaccines involved protect against Hib—or Haemophilus influenzae type b—disease and other conditions; Comvax also prevents against hepatitis B.  The vaccines were distributed beginning April 2007 and all but one lot was distributed in the United States.  Merck supplies about half the 14 million doses of Hib vaccine used in the U.S. annually.  FDA inspectors visited the Montgomery County plant on 30 separate occasions from November through January.

The Merck plant also makes Gardasil, the controversial cervical cancer vaccine.  A 2007 analysis by Judicial Watch of  Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect  reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported.  Despite such reports, Merck has made aggressive efforts to convince state legislatures to make Gardasil  mandatory for young girls.

In a posting on its website, the FDA said it "does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck." The FDA also said it did not expect the deficiencies to affect availability of the firm's vaccines, except for the recalled PedvaxHIB and COMVAX vaccines.  The FDA has given Merck 15 working days to correct the violations cited in  the warning letter.


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