Let the PR begin. Merck says it isn’t aware of any ‘adverse events’ stemming from bits of charred shrink wrap found in some vials of Gardasil, Varivax and Pneumovax; of course, the pharma company didn’t think any had stemmed from previous problems with metal particle contamination or cracked vials, either.
Not that it would have necessarily rushed to tell the FDA about problems anyway. The FDA saw fit to give Merck a rap over the knuckles for delaying adverse event reporting—something that readers of this blog have complained about endlessly after bad experiences. And according to Merck, the worst that recipients of one of years' worth of tainted vaccines can expect is injection site irritation. They know this how, exactly?
Still, you can rest easy.
“What we are seeing is that the severity and criticality of observations [by FDA inspectors] are declining,” James Robinson, vice president of vaccines product and technical operations, told the Wall Street Journal. “What we’ve seen in the last few inspections tells us we’re on the right track.”
Gosh. That makes me feel a whole lot better about the potential for one of my kids having a particle of metal or burned plastic injected into her flesh, and thence her system. Things are better than they were! Who needs perfect?
Just repeat after me: it’s statistically insignificant, and so is anything you might suffer afterwards.
Meanwhile, my daughter needs a tetnus booster. Guess I'd better go along to check for cracked vials and to cross my fingers about contamination.