Saturday, December 21, 2013

A Single Lot Of Gardasil® (~740,000 Doses) Recalled -- Only Ten Vials Actually Affected

Two opening notes: (1) this is Merck's entirely voluntary, not government ordered, recall; (2) while glass bits should never be seen in a Gardasil® vaccine vial, it is a near certainty that no girl or woman has been injected with a defective dose -- and only ten non-conforming vials have been found, in the entire lot of nearly three quarters of a million doses. So the whole lot will be destroyed. The risk rate then was just a bit over one thousandth -- of one percent.

In short, the public is not, and was not ever at risk here. All clinics in the US are trained to first visually inspect the dosing vial, and these glass bits are visible to the naked eye. So, it is extremely unlikely that any defect like this would actually be injected. Having said that, there is a separate debate over whether very young girls should be given the vaccine at all -- but that isn't today's story. [We've covered that before, here, in any event.]

Here is a bit of the story from yesterday's Wall Street Journal -- do go read it all:

. . . .Merck & Co. said it is voluntarily recalling one lot of its Gardasil vaccine for human papillomavirus, or HPV, due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process.

The pharmaceutical giant said the lot was distributed between Aug. 20 and Oct. 9, and that no other distributed lots of Merck product are affected.

According to the U.S. Centers for Disease Control and Prevention, there were 743,360 vials in the lot, and Merck estimated that roughly 10 of those vials could have glass particles in them.

The CDC said that people who have received the HPV vaccine don't need to take any action as a result of this recall, and that to date no adverse events related to this lot have been reported other than mild reactions, like redness or swelling at the injection site. . . .

So it goes. That redness is seen even in perfect lots -- in a small number of people vaccinated. Have a sanguine, safe and joyful holiday -- one and all. And do keep it spinning in good karma, too!

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