A company based in Iceland has developed a data-logger solution for monitoring temperature standards for COVID-19 vaccines across the globe.

Distributing the COVID-19 vaccine throws off logistical challenges of mind-boggling complexity: Billions of vials in millions of containers have to be shipped as quickly as they are manufactured to tens of thousands of separate locations throughout the globe, and with exacting temperature standards and cold storage necessary from start to finish. Each dose must be monitored closely to ensure integrity or the vaccine could be rendered useless, with potentially deadly results.

A company based in the Iceland town of Kopavogur provides a solution to this need for detailed monitoring across great expanses. Controlant created the technology being used by drug maker Pfizer to monitor every dose of vaccine being shipped globally, from the time it leaves a manufacturing plant, until it is administered in someone’s arm.

The process works like this: Pfizer attaches reusable data loggers made by Controlant to each box of vaccines. These advanced sensors relay to cloud-enable software platforms in real time critical information about the vaccine, including location, temperature, light, movement, possible security breaches and package tampering. Pfizer is able to integrate this software into its own enterprise resource planning systems (ERPs) and quality management systems or use a Controlant platform.

Making the journey more problematic: Pfizer’s vaccine must be stored at ultra-low temperatures for most of its shelf life. And, complicating matters further, the global pharmaceutical giant decided to distribute the vaccines directly in the US in just-in-time flexibility to vaccination points, instead of using wholesalers and traditional distribution centers.

Controlant also provides its technology directly to the US government, including the Center for Disease Control and the Department of Health and Human Services.

The data can be broadcast up and down the chain, so all the parties know what’s going on. This enables both shipper and carrier a degree of visibility unimaginable a few years back. It gives shippers and recipients, including hospitals and clinics, not only knowledge of when supplies are expected but the condition of those supplies even after arrival. It provides necessary documentation to health authorities for both regulatory clearance and record keeping. It generates data analytics capable of split-second decisions on everything from alternate destinations to efficacy determination.

This kind of monitoring is groundbreaking. It provides an efficiency and reliability on a global platform within critical-care products and their cold chain that were practically incomprehensible before. Sophisticated track-and-trace technology points the way to a much more proactive — rather than reactive — supply chain monitoring.

“We’ve moved from ‘What happened?’ to ‘What is happening and how can we respond?’” said Gisli Herjolfsson, Controlant co-founder and CEO.

Gisli Herjolfsson, Controlant co-founder and CEO
Gisli Herjolfsson, Controlant co-founder and CEO

According to Herjolfsson, this real time data relay enables not only immediate alerts, but decisions that can be made extremely quickly. Most of the vaccine arrives without any issues. But say, for example, the sensors detect a temperature deviation. A customer immediately gets an email saying “hold off on using these vials.” Pfizer’s quality control assesses the fluctuation and determines whether the vaccine is still OK. Usually, within 30 or 40 minutes, the customer receives an email with instructions on what to do.

“What we did in this project is to make sure that all communication would be automatic,” said Herjolfsson, who spoke to American Journal of Transportation (AJOT) over Zoom and also provided written answers to questions. “So even though I’m at the hospital, I don’t necessarily have access to the same platform, I’m always notified and I can track my shipment when it arrives.’ It says ‘hey, your product has been released and it’s good to use’ or ‘can you please wait for us to analyze something?’”

That automatic pushing of information is absolutely essential. “For the sheer volume, it’s very time sensitive, environment sensitive and just sensitive overall. It’s so critical,” Herjolfsson said. “What the COVID projects have shown and proved, not just to us, but also to the industry, is that the future of supply chain can be done, the tracking automation can be done,” said Herjolfsson.

Biologics and Biosimilars

Pharmaceuticals are moving quickly to what are called biologics and biosimilars, drugs that are made from living organisms or have components of living organisms. These not only require much stricter temperature controls, but tend to be much more costly on a dosage basis than traditional drugs. That means that monitoring a shipment is that much more critical, with more information necessary.

“We’ve set the precedent,” Herjolfsson believes.

According to Herjolfsson, Controlant was able to develop its technology for the COVID vaccine monitoring within five months, a process, he said, that would normally have taken years.

The company was founded by Herjolfsson and two university friends in 2007, but made its initial foray into pharmaceuticals-pharmaceuticals-related monitoring during the H1N1 influenza pandemic two years later. The Icelandic government funded Controlant’s monitoring of the vaccine, a project, Herjolfsson said, that demanded just a one-month rollout.

Controlant now offers its track-and-trace technology to a variety of cold-chain related industries including food and beverage.

Within supply chains, track-and-trace technologies are developing rapidly. Cold chain is no exception and temperature monitoring are commonplace.

But pharmaceuticals add layers of difficulty to the monitoring process. Herjolfsson cites a typical Amazon delivery, where there’s a kind of basic visibility technology that’s available for all parties. In the end, however, a box is left at a doorstep, and that’s it.

Precise Monitoring

Pharmaceuticals, in general, and the vaccines in particular are a different matter entirely. Drugs can’t just be left at the doorstep for pickup. Nor can there be a risk of a temperature spike that is commonplace even in most fresh produce. Precise monitoring must continue from the moment a drug leaves the plant until it is dispensed, and by a variety of players. “All of these parties actually have a real time visibility throughout the entire journey,” Herjolfsson explained.

This underscores a necessary development in the COVID vaccine rollout: the breaking down of supply chain silos. The more information is shared, the more efficient the process. Technologies such as Controlant’s facilitate this kind of participation, but the various parties involved must be willing and open to share. Herjolfsson, for one, believes this has been successful with the Covid vaccine. “One of the most notable things we are witnessing is an unprecedented level of collaboration among stakeholders throughout the entire vaccine supply chain,” he said.

The sheer volume of shipments traveling throughout the supply chain at once, but bound for such disparate destinations, makes the COVID vaccine distribution extraordinarily unique. So, coordination and collaboration between everyone along the chain is all the more important. It also means there can be virtually no time lag for information to be passed and assessed. As Herjolfsson pointed out, vaccine centers need to know when vaccines are arriving, in what quantity and if there are delays. Various carriers need to know how many containers to expect and when. The manufacturer needs to know everything from delivery schedules to usage to weather conditions.

And all this is happening not just in one state or one region or one country, but globally. Millions of doses of vaccines are whizzing every which way.

This will get trickier in the months ahead. Through the World Health Organization’s global vaccine access program Covax, vaccines are beginning to roll out too much poorer countries, and there’s understandable concern about infrastructure support, especially temperature maintenance.

Herjolfsson, for one, is upbeat that at least the monitoring won’t be compromised. “We came together to work on a global solution” he said. “We were able to create this harmonized single process for everyone. And for me, that was just fantastic.”

While attention is squarely focused on the COVID vaccines and the necessary supply chain, several parties are beginning to examine what all this means to the future of cold storage and transportation. Because the devices are reusable, and because so much information is traceable, these systems are becoming much more cost effective, Herjolfsson maintains. That reduction in cost means that this kind of system could see wider spread usage in the future, and not just be limited to the most expensive or critical medicines.

“It’s not just about shipments. It’s about real time inventory movements. It’s about automatically billing your customers. There’s a whole lot this technology can bring to the table where companies, even large ones like Pfizer and the like, can think about going the Amazon model.”