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Merck Vaccine Facility Cited for Problems by FDA

Apr 25, 2008 | Parker Waichman LLP Federal regulators who investigated Merck & Co.’s vaccine plant in Philadelphia, Pennsylvania cited a variety of potentially serious problems.  According to the report, contaminated packaging of children's vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots were among the problems cited by U.S. Food and Drug Administration (FDA) inspectors.  Based on an unpublished FDA report the Philadelphia Inquirer obtained the information through a Freedom of Information Act request, the article said inspectors found 49 areas of concern.

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.

Hib was the leading cause of bacterial meningitis in children under five years of age, according to the U.S. Centers for Disease Control and Prevention (CDC).   At the time of the recall, Merck said that in addition to the doses recalled—roughly four months worth of production—it quarantined nearly a year’s worth of other, possibly suspect doses, and doesn’t expect to supply any more until at least next October.  That means roughly two years of normal production is unavailable.

Merck is one of the few drug makers that make vaccines and in recent years has launched four successful new ones, including Gardasil, to prevent cervical cancer.  Last year, sales of all its vaccines totaled $4.3 billion.  In January, a number of deaths were found to be linked to Gardasil injections, which had European regulators looking more closely at the drug.  Gardasil is one of two approved injections licensed for use in the United Kingdom (UK) to protect against cervical cancer.  In the U.S., the FDA approved Gardasil in 2006 to prevent against four Human Papilloma Virus (HPV) strains responsible for 70 percent of all cervical cancer cases.  One young women who received a Gardasil injection died in Germany, another woman in Austria died following her Gardasil injection, and three other young women—ages 12, 19, and 22—died in the U.S. days after Gardasil was administered.  And, FDA documents indicate Gardasil may be responsible for at least eight deaths.  Since its approval, there had been 3,461 complaints of adverse reactions to Gardasil.  In several instances, blood clots were reported following injection; other side effects include paralysis, Bells Palsy, Guillain-Barre Syndrome.  Of 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.  Despite this, Merck continues to market Gardasil as being nearly side-effect free.

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