Merck is taking heat from the U.S. Food & Drug Administration (FDA) over contamination in some of its vaccines. According to Fox Business, charred pieces of plastic shrink wrap were found in vaccines such as Gardasil (HPV), Varivax (chicken pox), Pneumovax (pneumococcal), Zostavax (shingles), and MMRII (measles, mumps, rubella).
The issue is not new. A formal FDA letter was issued to Merck in 2008 over problems at its West Point, Pennsylvania plant, said Fox Business. The problems didnâ€™t end there. Agency inspection reports indicated other problems including metal pieces in some products, cracked vaccination vials, and Merck delaying its adverse event reporting to the FDA concerning its West Point plant, said Fox Business. The plant is Merckâ€™s largest for vaccine manufacture.
Merck said itâ€™s resolved most of the problems and no new FDA warning letters have been issued, said Fox Business, which added that Dow Jones Newswires obtained the agency inspection reports (Form 483s) under the Freedom of Information Act.
Since November 2009, Merck submitted reports to the FDA of no less than 12 occasions of charred shrink wrap turning up in vaccines; 8 originated with customer complaints and 4 with internal Merck testing, noted Fox Business. Merck moved from shrink-wrap to plastic or cardboard trays for most of is incoming vials, said Robinson, wrote Fox Business. As of the April inspection report, the agency said shrink wrap was used in some incoming vials, rendering the drug maker’s initial inspection response inadequate, said Fox Business.
In the current case, pieces of shrink wrap werenâ€™t removed from the vials and were charred during sterilization, which involves heat, explained Fox Business, citing an FDAâ€™s April inspection report. Some defective vials reached customers. According to Robinson, Merck is planning to stop using shrink wrap on all of its incoming vials by year end 2011. Regardless, Shelly Burgess, FDA spokeswoman, pointed out that a foreign item in an injectable product is of concern.
Thereâ€™s more. Earlier this year, Merck wrote to physicians warning them about brown particles in Antivenin (black widow spider bites) vaccines; that small pieces of “inert carbon material” (shrink wrap) could stick to the inside of the vials and turn brown when sterilized, said Fox Business. The particulates could cause injection site reactions, said Merck, but shouldnâ€™t affect drug potency or product sterility, said Fox Business.
Last August, Merck was accused of neglecting to report certain adverse events concerning patient use of its drugs within the legally mandated 15 days. In February 2009, an FDA inspector wrote that metal particulates were found in some Merck products and noted the presence of cracked vials, said Fox Business.
The report indicated that Merck should have conducted a more thorough investigation and follow-up; doctor complaints have also been received by Merck over bubbling and foaming in some vaccines.