Vaccine Failure: Is Your Office a Cause?

November 30, 2015
Terry Brenneman, MD
Terry Brenneman, MD

You may think you and your staff are on top of this problem. Results of a survey performed during a pertussis outbreak may help you think twice.

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We all have seen, heard about, or experienced vaccine failures. Could our office refrigerators be partly at fault? Refrigerated  vaccines must be stored between 2°C and 8°C (35°F and 46°F). Temperature excursions can damage potency or result in shortened shelf life. And we’re not talking about chump change here. Many private pediatric practices have more than $100,000 worth of vaccine in a single refrigerator according to a survey published in Pediatrics. How much do you know about storing this precious cargo? 

Your nurse tells you that some vaccines stored on the top shelf, where the cold air is pumped into the refrigerator, look frozen.

1. You tell her to:

A. Put the vaccines on a lower shelf and call the manufacturer to find out what you should do.

B. Remove the vaccines from the refrigerator, throw them out, and write off the loss.

C. Thaw the vaccine vials in warm water and try to use them within 8 hours.

D. None of the above

For answer, discussion, and another question, click here.

Best answer: D. None of the above.

Many vaccines are essentially destroyed by freezing. Simply putting these potentially worthless vaccines on a lower shelf without doing something to ensure they won't accidentally be used by your nursing staff is not the best answer. You always want to call the vaccine manufacturer. Many will replace the vaccines at no charge as long as you can send the damaged product back to them.

I'm sure you are thinking now, “This would never happen in my office. My nurses record the temperature twice a day and know to tell me if any of the temperatures go out of range.” 

The CDC now recommends using a data logger that continuously monitors the temperature 24 hours a day so that temporary excursions are recorded. DTaP vaccines are particularly sensitive to freezing. A few years ago, Houston, Texas, was undergoing a pertussis outbreak. A researcher decided to look at vaccine storage in 54 refrigerators in 13 health centers. The health centers followed Vaccines for Children Program guidelines that call for recording temperatures from digital thermometers twice each workday. Data loggers were placed and refrigerator temperatures were continuously monitored for at least 6 days.

2. Can you guess the results?

A. More than 50% or the refrigerators had excursions out of the normal range.

B. More than 20% recorded temperatures below freezing.

C. Of the refrigerators that had freezing temperatures, the average time below 0°C was about 2 hours.

D. All the above are true.

E. A and B are true.

For answer and discussion, please click here.

The sad and frightening answer: D. All the above are true.

The researcher then documented a relationship: The centers with freezing temperature excursions had higher rates of pertussis in their areas as compared to the areas served by health centers with no freezing temperatures recorded. Is one of the reasons for the poor efficacy of our pertussis- containing vaccines our fault due to refrigerator temperature excursions? 

Get a data logger and find out for yourself. A $50 investment on a data logger today may save you thousands and headaches down the road.

References:

Coleman MS, Lindley MC, Ekong J, Rodewald L.Net financial gain or loss from vaccination in pediatric medical practices. Pediatrics. 2009;124:S472-S491.

McColloster P, Vallbona C. Graphic-output data loggers for monitoring vaccine refrigeration: implications for pertussis. Am J Public Health 2011;101:46-47.