The Food and Drug Administration has found in recent inspections that vaccines are being manufactured with bits of shrink wrap in them. The inspections were carried out in April 2011 and they wrote in their report:
"Since 23rd November 09 this firm (Merck) has submitted 12 biological product deviation reports, eight of which arose from customer complaints and four of which were found during retention sample review. The source of the charred shrink wrap was found to be pieces of protective shrink wrap on incoming glass vials that failed to be removed during vial washing and were subsequently charred during depyrogenation."
In other words, the shrink wrap wasn’t properly removed from the vials prior to them being cleaned to use for vaccines and the left over wrap became burnt during sterilization using heat. This may pose a health risk to patients, although no adverse events have been reported so far.
Affected vaccines include:
Pneumovax 23, lot numbers 0627X, 1626X and 813Y
Gardasil, lot numbers 0331Z, 0886Z and 0992Z
Varivax, lot number 0477Y
PedvaxHIB, lot number 1421Y
There have also been complaints about MMR, Zostavax and Comvax (lot numbers obscured).
It’s not the first time that Merck has been in trouble. In 2008, the FDA sent the firm a warning letter about several of its vaccines because of failure to check unexplained discrepancies in the batches, not testing other potentially affected products, over-pressurizing vaccine vials, shoddy packaging including shedding of fibers into the product, failing to do tests that ensure quality and purity, sterility failure, no evaluation of vaccine components that may be passed their Use By date (due to being stored for years) and inadequate cleaning and sterilization practises.
A warning letter has not been sent regarding the shrink wrap and the information was only discovered using the freedom of information act.
Merck has begun to use plastic containers for its vials, instead of shrink wrap, but they are still being used for pneumovax 23. Merck says its aim is to replace all the shrink wrap with plastic containers by the end of the year.