Out-of-Control Temperatures Endanger Vaccine Recipients

Vaccines are truly miracle drugs. Polio has been effectively banished from the human population. In the U.S., the Center for Disease Control (CDC) recommends a regimen of vaccines for infants and children to protect them from otherwise common diseases such as chickenpox, Hepatitis A and B and polio. DTaP covers diphtheria, tetanus and pertussis. MMR combines protection for measles, mumps and rubella. Those old enough recall the first polio vaccinations in the 1950s.

The CDC feels vaccines are so important they sponsor a program called Vaccines For Children (VFC) which provides low or no cost vaccinations to children who qualify due to financial hardship. States enroll and administer the program which has increased the number of children vaccinated from 60% to 70% in the 1970s to over 90% for most childhood diseases in 2010 according to a 2014 CDC Report. To help insure vaccines administered are safe and effective, the CDC provides guidelines providers have to meet including storage at proper temperatures. Vaccines can be degraded by elevated or freezing temperatures making them ineffective. Proper refrigeration is required and storage sites are required to keep temperature logs to the CDC to show the vaccines provided are maintained properly.

Despite this, a 2012 U.S. Department of Health and Human Services report titled Vaccines For Children Program: Vulnerabilities In Vaccine Management found “VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with non expired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation. Similarly, none of the five selected grantees met all VFC program oversight requirements, and grantee site visits were not effective in ensuring that providers met vaccine management requirements over time.”

This is in the U.S., a country with first-rate medical facilities, a stable electrical, communication and transportation infrastructure, and highly trained medical professionals. Sadly, those who received vaccines from providers that did not meet the requirements may or may not be protected from the diseases the vaccines are designed to prevent. This presents a dilemma of whether or not to re-vaccinate those who received vaccines from those sites, doubling the VFC program cost.

If this can happen in the U.S., what does the situation look like in a developing country, India for example. A 2016 World Health Organization Bulletin titled “Frequent exposure to suboptimal temperatures in vaccine cold-chain system in India: results of temperature monitoring in 10 states” provides some insight. The authors looked at ten states in India and placed test boxes in vaccine storage areas to monitor temperatures in various locations throughout the cold chain.

Data from India vaccine monitoring study examined each segment to determine compliance level across the cold chain.

Interestingly the data demonstrates that vaccine storage temperature compliance rates in India are in some cases better than the U.S. and in some cases worse. The devil is in the details. The study and others will be examined in future pieces to glean insight and provide best practice guidance for cold chain compliance across the globe.

For those responsible to maintain vaccines in their facilities, knowing temperatures are out of range and potentially rendering the vaccines ineffective after the fact is interesting but not helpful in the short-term. Many vaccines are produced in batches and not easily replaced, seasonal flu vaccines for example. In all cases, those scheduled to be protected will have to wait or may never receive the protection they require. Fault-tolerant, cloud-based cellular temperature monitoring with devices from SmartSense can alert medical professionals before the damage is done by providing not only email or text notifications but phone calls when temperatures begin to rise. Being able to take action before vaccine effectiveness is compromised is essential to protect the most vulnerable recipients: our children.