Merck vaccines contaminated with plastic, says FDA

Merck vaccines contaminated with plastic, says FDA

August 18th, 2011 // 12:57 pm @

Vaccines made by Merck & Co at its West Point facility in Philadelphia, US, have been found to be contaminated with pieces of plastic on a dozen occasions since the end of 2009, according to the US FDA.

Inspections have shown that pieces of plastic shrink wrap have been discovered in a number of Merck’s vaccines, including Gardasil for human papillomavirus, the chickenpox vaccine Zostavax and Pneumovax for pneumococcal disease.

The agency believes the contamination took place because shrink wrap used to protect vials had not been completely removed ahead of the vaccine filling process.

The revelation is the latest in a series of compliance problems at West Point, which first came to light after the FDA sent Merck a warning letter in 2008, and this has resulted in intermittent shortages of vaccines such as adult hepatitis B shot Recombivax HB and MMR plus varicella vaccine ProQuad.

These problems – coupled with ongoing investment programmes at other vaccine-making facilities in Durham, North Carolina, and Ireland – have led to speculation in some quarters that Merck’s management may be shifting priorities and focus away from West Point, which remains the largest facility in its vaccine production network. Merck has insisted it remains committed to West Point and is in the process of upgrading equipment there.

A Dow Jones report notes that while the plant has received a number of Form 483 citation reports since 2008, it has not been served with another warning letter.

In all, 12 incidents of shrink wrap contamination have been reported since 2009, and Merck has responded by moving away from the use of shrink wrapping in favour of cardboard trays. Some vials re still shrink-wrapped, however, and the company says it hopes to phase these out by the end of the year, according to Dow Jones.

Merck said it does not believe there have been any adverse events associated with the plastic contamination problem.

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