Solving Cold Chain Challenges for COVID-19 Vaccinations
By Upender Solanki, Managing Director, Americas
Since the onset of the pandemic, governmental agencies and biopharmaceutical companies have been working tirelessly to develop a COVID-19 vaccine. The good news is promising vaccine candidates have moved through the Emergency Use Approval (EUA) process and are already being distributed on a limited basis.
When these vaccines go into full scale production, the cold chain will need to be ready to handle the high volume of product being shipped around the globe. Additionally, the distribution requires specific environmental conditions be maintained, such as temperature that can vary from simple refrigeration to extreme cold, such as -94°. Any product requiring a temperature of -80° F or colder is part of the “ultra cold chain” which adds another layer of complexity especially during the last mile. How will stakeholders track product across the vaccine distribution network and ensure its stability?
Challenges of the Vaccine Cold Chain
First, let’s review the challenges in a bit of detail.
- Temperature monitoring – Like most vaccines, any COVID-19 vaccine will require strict adherence to a tight temperature range. But different vaccine candidates have different temperature ranges. It will be hard to predict which candidates will emerge and what temperatures they will require. Furthermore, some of the possible vaccines require much lower temperatures than the typical vaccine, as low as -80° Celsius (-112° Fahrenheit).
- High volume – According to the International Air Transport Association (IATA), delivering a single dose of vaccine to 7.8 billion people would require 8,000 aircraft the size of a Boeing 7471—and this is for one dose only. Even in the most optimistic scenarios, distributing the COVID-19 vaccine will strain the entire cold chain, with ripple effects affecting the distribution of other pharmaceutical products. As the industry focuses on the safe storage, transport and handling of several vaccines, manufacturers and pharmacies will be scrambling to maintain supplies of other necessary medications and supplies.
- Security – The pharmaceutical industry is attractive to thieves and counterfeiters due to the high value of medicines and drugs. The COVID-19 vaccine will be an especially rich target because of the high demand and low supply volume at the beginning of distribution. It will be important to ensure and verify that these vaccines reach their destinations without having been compromised in any way.
- Inventory monitoring – Authorities must know vaccine inventory levels in real-time, as well as which hospitals and other facilities have received the product. Real-time visibility throughout the entire ecosystem will also be crucial as vaccine distribution clogs bureaucracies that are not ready to deal with such high volume. It will be especially important to be able to monitor temperature and other environmental factors when shipments are waiting at a port for clearance, and to be able to determine that vaccines have not lost their effectiveness due to quarantine delays.
- Regulatory compliance – Along with the special challenges of distributing a vaccine for a global pandemic, the normal regulatory, licensing and tracking requirements for pharmaceutical and biologic products still apply. These requirements may differ from country to country, such as the U.S.’s DSCSA or the EU’s FMD.
- Diversions – Limited supply of the vaccine may introduce product diversion risk from authorized medical sources into illegal channels, which can impact product quality, cost of programs and consumer safety. The result is the patient or consumer does not receive the right product at the right time, and a potential interruption in supply for legitimate needs.
Cold chain stakeholders have been preparing for the last few months – buying dry ice, building cold distribution centers and more. They are also fine-tuning and upgrading their technology to meet these challenges.
The Intelligent Supply Chain: Key to the Solution
The foundation to meeting many of the worldwide COVID-19 vaccine distribution challenges is visibility throughout the supply chain. By creating intelligent collaboration between stakeholders, the product legitimacy can be ensured from origin through production to delivery and consumption. The access to real-time data helps prevent environmentally compromised and counterfeit products from reaching patients. The risks increase with higher volumes and demand, a greater number of countries involved in distribution, and a larger number of vaccines—meaning that traceability becomes even more critical for success.
The connected intelligence of a vaccine collaboration hub is critical for:
- Production visibility
- Traceability and verification with recorded chain of control and custody
- Monitoring environmental conditions
- Handling supply chain disruptions
- Providing compliance reporting
- Ability to adjust to changing conditions (demand, supply, new regulations, etc.)
For example, track and trace technologies integrate well with data-driven systems, such as blockchain, IoT components and smart sensors. A more holistic system provides real-time information about pharmaceutical and vaccine products, often down to the individual package level, including monitoring the environment to ensure that temperature and other requirements are met throughout transport and handling.
With access to shared data, cold chain stakeholders can make critical decisions and strategies based on real-time information. It enables them to respond nimbly to sudden changes in supply, demand and potential bottlenecks, making operations more predictable and helping prevent loss and waste. The intelligent supply chain creates greater collaboration and visibility throughout the extended vaccine cold chain.
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