During the COVID-19 crisis, innovative mRNA vaccines stepped into the spotlight, with media outlets reporting on every stage of their development, distribution and delivery to patients. These new mRNA vaccines had to be kept cold throughout their shipment and storage: the original formulation of the BioNTech/Pfizer vaccine, for instance, required ultra-low temperatures (between −90 °C and −60 °C). The mRNA vaccines’ temperature requirements raised new questions for public health officials: how could pharmacies, clinics and other sites gain access to the high-performance freezing and storage technology needed to maintain the quality and safety of these highly sought-after vaccines?
But COVID-19 vaccines aren’t the only ones whose temperatures must be maintained within specific ranges. From vaccines protecting against the varicella-zoster virus or Hepatitis B to those used to safeguard our pets against rabies, many widely-used immunizations are sensitive to overheating, freezing or both. When clinics, pharmacies or laboratories rely on cold storage equipment that wasn’t purpose-built for use in these settings—and designed to meet new CDC-sponsored vaccine storage standards—they risk wasting vaccines, or even worse, compromising their patients’ health.
What’s lurking behind the freezer door?
Consumer-grade refrigerators and freezers remain commonplace in clinical settings ranging from retail pharmacies to physicians’ offices, even though the CDC recommends that only purpose-built or pharmaceutical-grade equipment be used for vaccine storage. A landmark study conducted by the U.S. Department of Health and Human Services (HHS) in 2012, for instance, found that vaccines stored by 76% of the providers participating in the research project had been exposed to improper temperatures for at least five hours within a two-week period. The World Health Organization estimates that as much as 50% of the total global vaccine supply is wasted each year because of problems with temperature control and cold chain logistics.
If clinical sites operate cold storage equipment that wasn’t specifically designed to keep vaccines within the required temperature range, they may incur significant risks. Household refrigerators and freezers are not designed to adequately protect vaccines from temperature fluctuations that result in spoilage or a loss of efficacy. While temperature control for the COVID-19 vaccines was mostly focused on protection from overheating, guarding vaccines against unwanted freezing is just as important—and often overlooked.
“If someone accidentally freezes a head of lettuce in their home refrigerator, the fact that it’s no longer good to eat is obvious,” says Joe LaPorte, chief innovation officer at PHC Corporation of North America. “With vaccines, there usually aren’t telltale visual indications that efficacy has been destroyed. But it doesn’t take much time at below-freezing temperatures to compromise a vaccine’s ability to protect against disease.”
“The challenge is being compounded by the fact that pharmaceutical companies are moving towards smaller and smaller vials and even single-use syringes,” he adds. “This has obvious advantages—it makes it easier to keep track of doses, and there’s less need to dip needles into a vaccine vial multiple times. But the downside is that smaller samples can freeze more easily.”
Modern cold storage solutions balance performance with sustainability
Today’s leading laboratory equipment manufacturers offer pharmacy-grade vaccine storage cabinets that not only maintain uniform temperatures accurately and consistently—even through repeated door openings, electrical brownouts, or elevated ambient temperatures—but that also meet emerging standards for energy efficiency.
In the past, ultra-low temperature laboratory freezers consumed huge amounts of power—as much, in some cases, as an entire household. In newer cold storage equipment, compressor speed and refrigerant use can be controlled intelligently, so that cooling takes place more quickly and overall energy consumption is reduced.
A refrigerator or freezer that meets the ENERGY STAR® standard—the key certification for energy efficiency in the U.S. market—will have been tested for uniform performance and its ability to recover temperature after multiple door openings. This gives buyers a reliable point of comparison, so that they can have confidence in how a cold storage solution will perform in the real world.
Safeguarding vaccines in order to deliver top-notch patient care
Going forward, stakeholders in both clinical facilities and laboratory environments will need to think carefully about choosing cold storage solutions that can create, maintain and restore the precise temperatures needed to ensure vaccine efficacy. The right refrigerator or freezer will conform to CDC recommendations and meet the NSF/ANSI 456 performance standard, ensuring a safe storage environment for vaccines, biologics or other temperature-sensitive therapeutics.
“Healthcare providers have a duty to their patients to make sure that they’re doing everything they can to make sure that the vaccines they’re putting into people’s arms will work as intended,” LaPorte says. “Ultimately, if vaccines aren’t stored properly, more people will suffer from illnesses that could have been prevented. COVID drew public attention to this, but it’s up to the entire healthcare industry to step up and protect patients. It’s possible that regulators will introduce new mandates in the future as well.”