Dayton, Ohio, USA, September 10, 2014
With the advent of flu season, patients swarm to immunization programs throughout the country. Yet, each year, some of those vaccinated succumb to life-threatening seasonal influenza. Sadly, many of these are preventable in that the primary cause of vaccine failure often occurs when pharmaceutical storage temperatures reach levels of degradation during the cold chain process. In a study of vaccine losses from 2010 to 2012, for example, the Military Vaccine Agency analyzed temperature-sensitive loss trends based on reported vaccine losses and found that all of those losses were preventable in that they were caused by a failure to properly store and handle the vaccines (MILVAX, 2013, p.3).
In the United States, each year on average 5% to 20% of the population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications. Flu seasons are unpredictable and can be severe. In 2009 for example, the US Influenza/pneumonia related deaths were approximately 53,000 and 50,000 in 2010 (CDC 2009 and 2010 National Vital Statistics System). Some people, such as older people, young children, pregnant women, and people with certain health conditions, are at high risk for serious flu complications. (Centers for Disease Control and Prevention, 2013, § 1)
When vaccines fall outside of specified temperature ranges, they lose some or all of their effectiveness. Heat, freezing, even exposure to excessive humidity, can degrade vaccines. If these conditions are extreme or exposure to less extreme conditions is prolonged, vaccine effectiveness can be limited or they can even be rendered useless. Incredibly, this situation is not at all uncommon.
Freddie Barber writes that during his time working with the Vaccines for Children Program (VFC) as both a Rep (Auditor) and State Coordinator, storage and handling issues were a primary focus. When they began in 2007, his state of Wyoming was completing 100% of audit visits for vaccine practices. However, by 2008 they had decided that “there was so much misunderstanding of good general immunization practices that we cut back on measuring immunization coverage audits to 60% in favor of spending more time training providers on vaccine administration, handling, and storage practices” (Barber, 2012). Barber found that facilities lacked thermometers to monitor temperatures; that clinics purchased refrigerators that were unequipped to store vaccines; that staff did not consistently monitor the temperatures or viability of vaccines; and that staff did not keep track of the actions that were taken when vaccines were found to be out of range (2012).
The ramifications of providing a vaccine that has been degraded are many. The greatest may be that a patient given an ineffective vaccine shows no signs that this was the case. Unharmed by the degraded vaccination and unaware of its inability to protect them from influenza, the patients are at risk of coming down with the flu and spreading it to others. This is particularly important when it comes to those in specialized fields such as healthcare workers and those who work with children and the elderly. Patients with health conditions who must guard themselves from the influenza virus live confident that they are protected while they possibly remain at risk of infection.
ABC News’ Dr. Timothy Johnson said on Good Morning America that the very young and the very old are in the most danger when it comes to the flu. He says it’s important to make sure they are protected with the shot [that are normally] effective in about 70 to 90 percent of the cases in young, healthy people and a little less in elderly people (ABC News, 1/6/2006).
There is growing evidence that failures within the cold chain distribution network, responsible for maintaining optimal temperatures from the manufacturers’ facilities to the patient, are often at fault for rendering vaccines ineffective with the last mile being the most prone for excursions. Without proper operation, maintenance, and monitoring of each phase in the distribution process, vaccines are put at risk. Maintaining temperatures throughout the length of the distribution chain is crucial for the safety of these medicines. For those whose role it is to transport the vaccines, stringent rules have been established for the transportation to warehouses/distribution centers and storage within them. However, even this has become increasingly complicated as distribution companies may work with third party partners who in turn may work with their own suppliers for the last mile distribution to the clinics.
The cold chain is only as strong as its weakest link; and, because no one entity controls the entire process from end-to-end, the challenge to maintain the viability of vaccines continues to be great. Part Two-Financial Cost
ABC News. (2006). Officials Fear Fatal Flu Season. Retrieved from http://abcnews.go.com/GMA/DrJohnson/story?id=124722&page=1
Barber, F. (2012). Cold Chain Failure Experience with State Vaccines for Children Program. Retrieved from http://www.stchome.com/blog/cold-chain-failure-experience-state-vaccines-children-program/
Centers for Disease Control and Prevention (2009 and 2010) Flu and Pneumonia Mortality data. Retrieved from www.cdc.gov/nchs/pressroom/states/FLU_PNEUMONIA_STATE_2010.pdf
Centers for Disease Control and Prevention. (2013). Seasonal Influenza Q&A | About (Flu) | CDC. Retrieved from http://www.cdc.gov/flu/about/qa/disease.htm
MILVAX. (2013). Vaccine Storage and Handling Guidelines. Retrieved from http://www.vaccines.mil/documents/1632_SH_Guidelines.pdf