COVID-19 action plan: Distributing clinical trials and vaccines

COVID-19, Cold chain management

As several pharmaceutical companies have initiated R&D processes to find a COVID-19 vaccine that can prevent further spread of the novel coronavirus, it is predicted that at the rapid pace at which researchers are currently working, a treatment could be available within 18 months and possibly sooner. Pfizer, GlaxoSmithKline (GSK), Gilead Sciences, Johnson & Johnson, Sanofi, and Moderna Therapeutics are among those leading the race to find a safe and effective vaccine. 

The cold chain could prove vital in the fight to tackle the pandemic. It is critical to focus on the quality of the supply chain to focus on the quality of healthcare and safety of those treated. Temperature excursions during the storage, handling, or distribution of temperature-sensitive clinical trial materials and ultimately, vaccines, pose significant public health and financial risks.  

For the highly-sensitive investigational products and materials used in clinical trials, cold chain failure may lead to patients being administered unsafe products, liability based on compliance infractions, inconsistent data results, or an entire shipment’s product integrity could be rejected by a quality department, resulting in costly delays. 

With numerous supply chains already stretched and much of the world focused on the race for a COVID-19 vaccine, its ability to deliver rapid results while conforming to quality assurance requirements and good distribution practices will soon be tested like never before. 

The lack of proper storage and transportation temperatures for vaccines is one of the common factors limiting full and equitable immunization in many countries. A recent Centers for Disease Control and Prevention (CDC) estimate suggests that $300 million worth of vaccines are destroyed each year due to improper storage and transportation. Should similar issues impact the supply of novel coronavirus vaccines, or worse, endanger patients, the industry could face major backlash. 

The experience of adapting to new challenges will likely prove vital when pharmaceutical manufacturers begin to distribute the temperature-sensitive COVID-19 vaccine. Just as the lessons learned from the crises thus far have forced pharmaceutical companies to adapt to new challenges, they have the potential to improve and accelerate the process of delivering new state-of-the-art treatments all over the world. 

Operational consistency will be key to reliable temperature-controlled logistics, no matter the context. The approach should be similar no matter where vaccines are traveling and whether products are subject to extreme cold or extreme heat, or whether products need to be kept at 15–25°C, at 2–8°C, or even lower. 

As most pharmaceutical companies do not own their distribution fleets, consistency can only be achieved through close collaboration of its service providers, using standard technology, processes, and oversight.  

Using real-time environmental monitoring and visibility technology and services consistently from the first mile through the last will be mission-critical to ensure that vaccines and safely distributed and reach the consumer. With the unexpected supply chain delays and disruptions that we have seen thus far, total supply chain visibility makes it possible to proactively mitigate risk, maintain the flexibility needed during these times of uncertainty, and protect and control clinical trials and vaccine products that will quite literally help shape our futures.  

After all, a temperature deviation in the supply chain does not represent simply a loss of money to the manufacturer; it might turn into a life-saving emergency. 

Next steps: 

  • Monitor environmental conditions of your critical vaccines in real-time, including temperature, relative humidity, and light in all receiving, transferring, storing, and holding areas. The monitoring solution should provide temperature excursion alerts around the clock, and services should facilitate rapid response if an excursion occurs to ensure quality and prevent product waste. 
  • Supply chain visibility data should be available on demand. With Controlant’s real-time hardware, software, and services, including 24/7 monitoring and response and data logger management and reverse logistics, our proactive partnership with pharmaceutical manufacturers and their logistics providers translates to greater visibility and better decision making. 
  • Reap the benefits of having custom dashboards that provide value-rich analytics and data on your supply chain, including excursions by origin sites, destinations, routes, and sub-routes, on your partners, including freight forwarders, airlines, packaging solutions, technology providers, and 3PL’s, and external points of interest, including cross-docks, storage facilities, harbors, distribution centers, and airports, and borders.  
  • Be ready for anything as the coronavirus pandemic continues. COVID-19 has challenged our limits. Now is the time to think ahead to prepare for the next phase and move from your clinical trials to your global vaccine distribution.  

Controlant is dedicated to lessening supply chain disruptions while providing visibility during this unprecedented time. Contact us to learn more.