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A CLOSE CALL, AND WHY WE NEED VACCINE VIAL MONITORS

 

Cook Children's generosity lets us use our time and resources to make a global impact on the immunizing community and all of our patients. One way we're doing that is though our involvement in trying to bring vaccine vial monitoring to the United States.

The background: Around the world, most vaccines are produced with a small dot on the label that fades out as the vaccine is exposed to temperatures above its designated storage limit. These were created to protect vaccines in areas where the cold chain may not be very good, like in underdeveloped countries with intermittent electrical service. In fact, the World Health Organization requires this protection on all of the vaccines it buys. 

Here in the U.S., manufacturers have not added these temperature-monitoring dots to vaccines because there is a small additional cost per vial (3 to 5 cents), as well as a significant cost to get FDA approval for all of the label changes that would be required. We also have a cold chain that is assumed to be very good.

Last weekend, we had a real world example of why this assumption may be incorrect. We had a practice order Varivax® on a Thursday. It was shipped out and arrived in Mesquite, Texas, late on Friday, then sat in the UPS warehouse over the weekend. It is currently nearly 100 degrees Fahrenheit in Mesquite, so we were concerned that the vaccine might not arrive at an acceptable temperature. Thanks to VaxCare, we could follow the shipment and could alert the office staff to confirm the temperature upon delivery. It arrived at 6 degrees Celsius. This product can be at 6 degrees Celsius for 72 hours, and so it was considered viable. But, what happens if each link in the cold chain from filling to administration assumes that it has a 72 hour window of safety? Because there is no way for each link to tell the next how much of the safety cushion has been used, there is actually no way to know if the vaccine you are giving is viable, or no longer useful.

As important as vaccines are for the health and safety of our community and the low cost of this additional safety measure, we think every patient is entitled to know that every vaccine they are given has the greatest possible efficacy. We're going to continue to push to bring our vaccines up to the standard that most of the rest of the world already requires.


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