In case you missed them, here are a few recent headlines that made the rounds:
- Ventura County administered thousands of vaccines that may not have worked
- Temperature mishap at clinic means children will need second vaccination shots
- Tetanus vaccine delivered in Leduc potentially ineffective: AHS
In all three of these cases, the vaccines were rendered ineffective because of improper temperature control.
These are not isolated incidents. The CDC found that almost one-quarter (23%) of vaccination errors reported in the United States between 2003 and 2013 were due to storage errors or administering expired vaccines. The authors of a more recent study by the Institute for Safe Medication Practices (ISMP) concluded that “vaccine errors continue with little change” after finding that the number of error reports increased by more than 100 in 2017 compared to prior years. In that study, 19% of the errors were due to expired vaccines or contamination/deterioration.
Obviously, ineffective vaccines can cause health problems. Namely, people who thought they were immune to a particular disease can get very sick.
But the problems go beyond unexpected non-immunity. As Keren Sookne wrote last month in Healthcare Packaging,
“When people are vaccinated by ineffective doses and go on to contract the disease, it spreads the idea that vaccines do not work. Public trust and compliance — domestically and abroad — are critical precursors to preventing dangerous gaps in immunity.”
To counter this idea, the vaccine industry needs to do everything it can to retain public trust, especially as the anti-vaxxer movement gets louder. Here are three things vaccine manufacturers can do to better ensure the effectiveness of their products.
1. Take a more holistic view of the cold chain
Keeping vaccines at an appropriate temperature from the minute they’re manufactured until the minute they’re administered is the best way to ensure their effectiveness. That’s why vaccine makers have put a lot of resources into maintaining the cold chain.
Most of these efforts have focused on the post-packaging phase of shipment, for example, using IoT solutions to monitor temperature levels during transport. While maintaining the cold chain at this step is essential, there’s another, earlier phase in vaccine manufacturing that’s often neglected: inspection and labeling.
In most facilities, vaccines are manufactured and then stored in unlabeled glass vials until shipping. When an order is received, the vaccines are taken out of cold storage for inspection and labeling. If you’ve ever enjoyed an ice cold lemonade on a hot summer day, you know what happens next: condensation forms. That moisture needs to dissipate; otherwise, you can’t see through the glass to perform a visual inspection and the label won’t stick. Herein lies the problem — drying the vials typically requires removing them from the cold chain and putting them into a conditioning room, often for as long as 48 hours.
To address this problem, we worked with some of the top vaccine manufacturers to develop an automatic vial dryer than can cut the time out of the cold chain from 48 hours down to as little as 5 minutes, with no vial damage or breakage. Learn more about this innovative solution.
2. Educate healthcare providers about the importance of proper storage
Many of the headline-making stories involve vaccines that were held at improper temperatures after they reached the provider’s office. But just because the vaccines are out of your hands doesn’t mean your job is done. There’s more at stake here than the reputation of the healthcare provider, or even of the manufacturer. As Sookne noted, when vaccines don’t work, it damages public trust of the field as a whole.
Healthcare providers aren’t intentionally giving ineffective vaccines to people. Oftentimes, they simply don’t know that their storage protocol may be causing a problem.
One study found that an education program focused on awareness and best practices significantly improved vaccine storage at medical institutions. As the manufacturer, you’re in the best position to provide the needed education.
Here are some resources you can use:
- CDC. Vaccine Storage and Handling Toolkit [website with link to resources]
- CDC. Vaccine Storage and Handling [eLeaning module]
- American Academy of Pediatrics. Vaccine Storage Chart [website]
- American Academy of Pediatrics. Refrigerators, Freezers, and Vaccine Storage [pdf]
- American Academy of Pediatrics. Checklist for Proper Storage and Handling Practices [pdf]
- Immunization Action Coalition. To Err Is Human; Not To Err Is Better! Vaccination Errors and How to Prevent Them [presentation]
- Immunization Action Coalition. Don’t Be Guilty of These Preventable Errors in Vaccine Storage and Handling! [pdf]
3. Ensure your labels and administration instructions are clear
Finally, although storage conditions are a big cause of vaccine errors, they certainly aren’t the only one. In the ISMP study, more than 40% of the errors were due to patients being given the wrong vaccine or the wrong dose.
The researchers looked at the contributing factors for the top 10 vaccines involved in reporting errors. Aside from temperature problems, here are the major issues, grouped by theme:
- Age-dependent formulations of same vaccine / not familiar with indicated patient ages for product
- Not familiar with dosing of product / not familiar with vaccination interval for product
- Not familiar with how to mix or prepare product / confusion regarding components of the vaccine
- Similar brand names / similar generic names / similar vaccine abbreviations
- Similar vaccine container labels / packaging
- Patient chart not checked before administration / patient age not verified before administration
- Miscommunication of drug order
- Routine check for expired products not conducted
As a vaccine manufacturer, you can’t control all of these factors. But you can help with some of them by ensuring that your labels and any instructions you provide are easy to understand and follow.
Ultimately, vaccines need to work. If we’re going to achieve that goal, all of us in the industry — vaccine makers, equipment suppliers, etc. — must first and foremost do everything we can to ensure that the vaccines being administered are effective.