As is the case with frozen foods, drugs, and produce, vaccines go through a rigorous, unbroken cold chain from the product manufacturer to the point of administration. Vaccines are especially sensitive to unwanted temperature fluctuations in the cold chain because administering vaccines damaged by excursions can be fatal.
Of more importance, it is incredibly hard, if not impossible to know that a vaccine has been rendered inactive due to poor temperature controls simply by looking at it. It’s also worth remembering that vaccines are usually distributed via long, complicated supply chains.
Because of exposure to a multitude of environments and handlers during the process of getting vaccines to market, all points in the cold supply chain must be closely monitored to avoid any environmental damage and loss of public confidence in the vaccines. Temperature monitoring for the vaccine cold chain is now more important than ever before because most countries are racing to inoculate their citizens against Covid-19.
Here are five vaccine temperature monitoring talking points you should know.
1- Demand still outstrips supply
Most Covid-19 vaccine trackers show that we’re close to hitting the 1.8-billion mark when it comes to the global vaccinated population. That’s just a drop in the ocean, considering that more than 88 percent of the worldwide population is still waiting for their turn to get the jab.
While the availability of the coronavirus vaccine may be lopsided in favor of high-income countries, one point is abundantly clear: demand far outstrips supply across the globe.
Here in the US, the situation is looking up given that over 286 million people have received at least the first dose, accounting for roughly half of the American population. Even so, approximately 60 percent of Americans are not fully vaccinated, which continues to fuel the skyrocketing demand for all three FDA-authorized Covid-19 vaccines.
In most states, where the eligibility of the vaccine has been extended to include anyone older than 12 years of age, some adults are still struggling to get vaccinated. Some states, such as New York, Indiana, and Texas, have set up contact lines and online portals where residents can schedule vaccination appointments and find out when and if they will be able to get vaccinated.
What’s challenging, however, is that some of these vaccine scheduling systems are so strained under an explosion of demand that some of them crash or are inaccessible several times throughout the day. It becomes even more frustrating when you take hours to try to get in, only to find there’s nothing available.
For example, over 200K people are reported to be on the vaccine waiting list in Seattle’s city-run vaccination program, according to the New York Times. Long queues and wait times at vaccination sites are also reported.
2- Trust and transparency issues still stand in the way
Even before the vaccination program started rolling out in the US, one of the biggest challenges the vaccines faced was gaining public confidence. This extended to everyone, from politicians to healthcare workers who were first in line to receive the jab.
Ensuring proper temperature controls, which in turn, guarantees the safety and integrity of the vaccine plays a big role in getting Americans to trust the inoculation. Vaccine makers Pfizer, Moderna, and Johnson & Johnson have done their part by submitting clinical trial data on their vaccines to the FDA and subsequently receiving approval for emergency use.
The majority of these vaccine manufacturers have also gone the extra mile to publish their findings in peer-reviewed, independent scientific publications. This has helped paint the vaccines in good light, at least in terms of efficacy and safety.
The public at large also needs to be informed about the vaccines’ performance on an ongoing basis. This will help dissipate public distrust issues that have long plagued the pharmaceutical industry. The ball is also in leadership’s court, so politicians, community leaders, and educators should lead the way by quashing misinformation and building public trust in vaccines through their relevant platforms.
3- The supply chain is essential
As public health authorities work to amp up excitement around vaccination, everyone involved in vaccine handling must also address the unprecedented supply chain challenges. One of these challenges is tackling the ultra-low temperature (ULT) storage requirements of Pfizer-BioNTech and Moderna.
Although all currently authorized Covid-19 vaccines require strict temperature monitoring, these two are especially finicky about exposure to environmental conditions because they are based on messenger ribonucleic acid (mRNA), which takes advantage of the coronavirus genetic materials to trigger an immune response.
For example, although the Pfizer-BioNTech vaccine can be rapidly manufactured, it must be kept in the freezer between -25°C and -15°C. When it reaches its destination, healthcare facilities can keep the vaccine refrigerated between 2°C and 8°C for up to 31 days, according to the US Centers for Disease Control and Prevention (CDC).
As Dickson addresses here, vaccines are highly temperature-sensitive and must be monitored closely. Any higher-than-recommended temperature will lead to rapid degradation, resulting in loss of potency. On the flip side, temperatures that are too low can deactivate the vaccine, damaging the containers and sensitive ingredients like diluents.
4- Security is as important as vaccine safety
Tremendous logistical challenges face the distribution and storage of the Covid-19 vaccines, but security is another top concern to consider in the cold supply chain. Companies must address both physical and environmental security concerns to prevent further delays and complications, along the way.
Environmental monitoring can address most problems such as temperature, humidity, pressure, and other controls. However, special measures must be put in place at every touchpoint in the vaccine supply chain to prevent tampering or theft of the products. The most critical points include where the change of custody happens, so they must be strictly secured and monitored.
5- The effects of loss of vaccine cold chain integrity are dire
The vaccine’s temperature stability can be affected anywhere along the cold supply chain if a strict monitoring scheme isn’t in place. The consequences of any loss in the supply integrity can be dire for the vaccine.
Of course, community and patient health will be the first victims. Vaccines exposed to poor temperature controls can be life-threatening and delay bringing the coronavirus pandemic under control. As biological products, vaccines are regulated by the FDA and any violations will result in citations and other punitive actions.
All things considered, mishandling of vaccines can lead to erosion of public trust in both the vaccine and the companies that produce them. Ultimately, issues with vaccine temperature controls can lead to direct financial repercussions due to reduced demand, recalls, and cost of intervention.
As key players attempt to deliver Covid-19 vaccines widely and safely, no stone should be left unturned. Temperature monitoring should play a central role in ensuring an effective and robust vaccine cold chain. Stakeholders should also ensure vaccine security, safety, and transparency to boost public trust and help the government hit its vaccination targets sooner rather than later.