FDA Found Concerns at Merck Vaccine Plant

The FDA found contaminated children’s vaccines and other problems at a Merck & Co. plant in Philadelphia that was combed.

According to an unpublished FDA report acquired by the Philadelphia Inquirer, inspectors found 49 areas of concern, including unwanted fibers found on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk lots of vaccine. 

Inspectors visited the plant on 30 separate days from November to January.  In December the company recalled 1.2 million doses of an influenza vaccine made at the Philadelphia plant due to sterility problems and the plant also quarantined near a yeas worth of other suspect doses.

A Merck executive, John McCubbins stated that none of the finished vaccines were contaminated and the company is fixing the problems.  The FDA has not ordered Merck to stop production and is reviewing how the company responds to the report.

Also Thursday, Deutsche Bank pharmaceuticals analyst Barbara Ryan wrote in a note to investors that the “deficiencies have been addressed and remediated with no consequences in terms of delays or shortages for any vaccine products.”  Meanwhile, a CDC spokesman said Thursday that the agency is not aware of problems with vaccines at the plant and so is not taking action.