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Vaccine Cold Chain Management Guidelines

– By Bradley Wingrave

29th January 2021

Your World, Smarter.

The Age of the Smart Vaccine Cold Chain

In response to the COVID-19 pandemic, the vaccine cold chain has faced global scrutiny. At the time of writing, nearly 10 billion people around the world have received COVID-19 vaccinations – just over half the world’s population. This is just the tip of the iceberg, however. 60.4% of people around the globe have received at least one dose. Only 9.5% of low-income countries have received a vaccination dose. Booster jabs and the continued roll-out of vaccination programmes have also kept cold chain vaccine storage a topical point for pharmaceuticals and health authorities.

What is a vaccine cold chain?

Cold chain vaccine processes depend on constant refrigeration at sometimes extremely low temperatures to:

  • maintain the viability of vaccines
  • prevent wastage

Cold chain storage: a matter of life and death

After manufacture, vaccines need to be transported to (and ultimately stored in) a network of healthcare programmes, clinics, hospitals, and healthcare centres around the world. This entails a network of cold rooms, fridges and refrigerated logistics, cold boxes, and carriers.

In the pandemic context, the importance of this is cast in stark relief. With COVID-19 and many diseases, time is of the essence and bottlenecks in the supply chain can have dire repercussions for whole countries and communities. According to PATH, from factory to healthcare outlet, it takes an average of four to six months. The COVID-19 vaccine is on a compressed timeline – which, in turn, emphasises the challenges of cold chain vaccine storage specifications.

The nature of vaccines

Most vaccines are made from perishable components, with ingredients that degrade at room temperature. According to the European Pharmaceutical Review, the Pfizer and BioNTech COVID-19 vaccine needs to be stored at -70°C (ultra-cold chain), but can survive at temperatures of 2° to 8°C for a period of five days. Other variants require higher temperatures, but a careful system of controlled processes will be required to maximise the effectiveness of the distribution of the COVID-19 and other vaccines.

Vaccine Cold Chain Management | Smarter Technologies
Vaccine Cold Chains | Smarter Technologies

The context: the inadequacies of the vaccine cold chain

The WHO’s Decade of Vaccines saw relatively large volumes of vaccines delivered and administered in many different countries around the world. This brought the shortcomings of the global supply chain to the fore across storage, logistics, and personnel. The result was bottlenecks, unnecessary wastage, and deaths. Add the urgency of the pandemic and these inadequacies stand to be emphasised.

On top of this, many global nations aren’t equipped for a roll-out of vaccines on this scale. The situation is rendered difficult by remoteness, economics and socio-economic processes, as well as healthcare infrastructure. In distributing vaccines to everyone, the solutions to the cold chain vaccine process needs to be adaptable to a range of factors.

Additionally, the COVID-19 vaccination programmes need to work in tandem with the delivery and administration of other vaccination programmes to avoid disruptions. The roll-out of the COVID-19 vaccine will place inevitable strain on the distribution of other very important vaccines.

A quick view of a few of the key challenges:

  • Maintaining temperatures throughout the entire supply chain, logistics, and storage journey, without disruption
  • Multi-location monitoring
  • Standardised monitoring
  • Manual data tracking
  • The role of temperature and additional conditions like shock in the integrity of shipments
  • The limited shelf life of many pharmaceutical products
  • It has been reported that 30% of deliveries are made with a degree of degradation or spoilage

Redefining pharmaceutical cold chain management guidelines

At the best of times, the pharma cold chain is riddled with complexities and intricate logistical considerations. It is always a high stakes set of operations. The pandemic has underscored the importance of vaccine cold chain logistics companies’ abilities to adapt to challenges. A major source of adaptability has been the adoption of technology. Through rapid, smart digitalisation, these companies are turning to data to drive change.

The integrity, safety, and effective delivery of pharmaceuticals is critical and real-time monitoring and data insights have proven to be the toolkit these companies need to meet demand. Let’s examine some of the common challenges and how smart technologies solutions from Smarter Technologies Group are presenting solutions at this high-impact time for the pharma cold chain.

Pharmaceutical Cold Chain Management | Smarter Technologies

One of the primary challenges is that pharma cold chain logistics are predicated on multifaceted operations. From production to distribution and cold chain vaccine storage, medicines need strict temperature monitoring, with a short window for warmer temperatures before these are said to be contaminated or ineffective. When it comes to temperature monitoring, the biopharma industry loses around $35 billion annually due to temperature control failures. This situation is poised for change.

When vaccine containers are damaged, exposed to undesirable temperatures, this is called closed vial wastage. Open vial wastage happens when a vaccine is opened and the balance of the doses aren’t used timeously or stored correctly. All forms of wastage have a knock-on effect, putting pressure on nodes all along the vaccine supply chain.

Personnel working across all nodes (sometimes in different locations around the world) need to co-ordinate carefully to avoid issues around production schedules and deliveries, stock shortages, unfulfilled demand, bottlenecks, vaccination accessories, and so on. This demands the creation of optimal processes and full transparency.

Smart cold chain logistics solutions offer real-time monitoring of moving assets throughout the cold chain. Improper controls on this front can lead to losses in many forms – from theft to inventory and supply management and damaged merchandise. Temperature sensors, location tags, and lid sensors deliver actionable alerts throughout production, storage, delivery, and warehousing. This leaves no point of the cold chain unchecked.

The idea of data-driven decision-making is great in theory. Traditionally, this is rarely practically achieved by pharma cold chain logistics companies. The vaccine cold chain management guidelines need to be viewed holistically to effectively use data as a strategic tool.

As with many other industries, vaccine cold chain logistics companies stand to benefit from retrospective analysis of data to streamline future operations. Smart technologies connect every touchpoint along the cold chain, with data insights accessible from a remote dashboard. End-to-end data insights have the potential to provide preventative and prescriptive solutions, rather than reacting once it is too late. Combined with historical data, this comprehensive data view is a powerful tool for vaccine cold chain logistics companies.

When it comes to product handover, many customers in the healthcare industry operate within the bounds of deeply specific receiving requirements. Thus, healthcare presents a situation where suppliers need to be attuned to the needs of their customers to ensure delivery of the right quantity, in the right condition, at the right time.

Smart technologies provide real-time monitoring of goods to ensure the integrity of every delivery is maintained. This standard of visibility makes for high-level inventory management at every stage of the cold chain.

Rigid compliance regulations surround these elements of the pharmaceutical industry. This means vaccine cold chain logistics companies tend to face a heavy administrative burden, with strong demands around transparency and accountability.

Smart technologies replace many manual processes with automated ones for the purposes of compliance record-keeping. Data is securely delivered in real time and stored on a remotely accessible dashboard. This system of cloud-based, automated record-keeping removes instances of human error and maintains exceptional standards around compliance reporting.

Smart vaccine cold chain monitoring in action

Pfizer has opted to use smart technology sensors to aid in monitoring the cold chain for vaccine deliveries. This is being implemented from the manufacturing location to the point of inoculation to ensure efficiency. This has shown how these sensors are benefiting the cold chain in practice. Most notably, one shipment in California was diverted from delivery when sensors alerted them that the temperature had dropped below the desired threshold.

The affected vaccines didn’t leave the truck, were returned immediately to Pfizer, and a replacement shipment was immediately dispatched to take its place. This is one example of how real-time tracking and monitoring allows the company to step in to counteract issues in the cold chain.

The Opportunities Created By Vaccine Cold Chain Monitoring

What are some of the features of smart cold chain technology?

  • Real-time monitoring through a system of IoT-enabled sensors and tags
  • Wireless transmission of data – globally and even in remote locations
  • Remote accessibility utilising cloud-based reporting systems
  • Condition monitoring for metrics beyond temperature
  • Seamless administration and reporting
  • Automation opportunities
  • Actionable notifications make for minimal losses and degradation
  • Data insights protect patients and end-users

Making the move to smarter pharmaceutical cold chain management

The range of cold chain monitoring smart technologies on offer from Smarter Technologies Group aims to simplify this traditionally challenging industry. These technologies are perfect for on-site use during manufacture, distribution, customs clearance, storage, and delivery to the end-user.

These are exciting times for advancements in the pharmaceutical cold chain. These customisable solutions ensure consistency and a steady supply of vaccines and pharmaceuticals at this challenging time in history. Undeterred by location, shipment size, or storage requirements, smart technologies are perfectly adapted to ensuring as many vaccines are delivered and administered to those who need them around the world.

Contact Smarter Technologies Group to find out more about smart technologies for cold chain monitoring.

About the Author: 

Bradley Wingrave has a wealth of business experience spanning more than two decades and his success in a number of entrepreneurial ventures makes him a forerunning expert on businesses, offices, facilities and legal compliance.

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