This report from Dow Jones indicates more woes for drug maker Merck. Specifically some bits of plastic in the form of shrink wrap have been found inside vials of vaccines made by Merck. The company says it is working to resolve the defective vaccines and that it is not aware of any instances of injury from the plastic bits. The defective vaccines were made at Merck’s biggest plant in West Point, Pennsylvania which was the subject of a 2008 letter from the Food and Drug Administration (FDA) about quality control problems included metal particles found in products and cracks found in vaccine vials.
The vaccines for Gardasil, Varivax, Pneumovax and Zostavax are all affected. The protective shrink wrap was initially used to cover glass vials and it reportedly was not removed before a heated sterilization process. The FDA has received at least a dozen reports of the plastic wrap found inside vaccines. Eight customer complaints were made to the FDA and Merck found four contaminated vials when it tested samples.
Merck’s 2010 vaccine sales amounted to $3.8 billion according to Dow Jones, so this finding is not a small revelation. Vaccine sales represent about eight percent of company sales.
In a separate action, Johnson & Johnson has had problems with its Fort Washington, Pennsylvania plant, which remains closed after FDA inspectors found unsanitary conditions and contaminated products. Insiders comment that aging equipment and budget cuts have contributed to compromises in quality.
Merck is lucky that plastic bits found in vials have not been injected into patients. An injured patient could file a product liability claim against Merck for such poor quality control. Merck says the problem is under control – it’s shifted to cardboard vial holders and only one in six million vials have been affected. Doctors had complained to Merck in the past about bubbling and foaming observed in certain vaccine vials. The FDA says Merck could have done more to investigate metal particles and cracked vials found in its facility in the past.
Sources: http://www.pharmalot.com/2011/07/is-that-plastic-shrink-wrap-in-your-merck-vaccine/#more-34018 and http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201107281824dowjonesdjonline000835&title=update-fda-faults-merck-plant-for-charred-shrink-wrap-in-vaccine-vials
