FDA inspectors found 49 problems at Merck's West Point, PA, vaccine plant--problems independent experts called "serious concerns." Among the issues cited were fibers on the stoppers of vaccine vials, contaminants in children's vaccines, and complaints that weren't always investigated, according to an FDA report obtained by the Philadelphia Inquirer. One of the FDA's criticisms concerned a manufacturing change Merck made to two childhood vaccines back in 2006. In December 2007, those vaccines were withdrawn because Merck couldn't guarantee their sterility.
Asked by the Inquirer to review the report, independent experts said that, while no single citation was egregious, the overall pattern caused concern. "It's the sum of many small things that puts the whole operation in question," one consultant said. Another expert who used to oversee FDA inspections said that the report suggested Merck might be understaffed. "Sometimes in a plant where everyone feels overburdened...they give up trying to do everything and just try to keep their heads above water," he said.
Merck's global vaccine manufacturing chief John McCubbins stressed that no finished vaccines were found to be contaminated and that Merck's own technicians had found and reported most of the problems. The vaccine recall showed that the company's quality controls are working, he said, citing the inherent difficulty of vaccine-making. He also said that the division's employment has kept pace with production and that the company will address the FDA's concerns. "We are absolutely confident in the quality of the product," he said.
- see the story in the Philadelphia Inquirer
- check out the WSJ Health Blog item