IPI Winter 2020

Page 90

Logistics & Supply Chain Management

COVID-19 Vaccine: Unique Distribution Challenges Call for a Unique Monitoring Approach The COVID-19 vaccine will leverage new distribution approaches, so monitoring its physical integrity through the supply chain from manufacturing to point of use will also require fresh thinking. With a lot at stake for all parties involved such as states, regulators, pharmaceutical companies and the general population, the margins for error in delivering a vaccine promptly and with uncompromised efficacy have never been tighter. COVID-19 Vaccine’s Unique Integrity Challenges Distributing the COVID-19 vaccine will be unlike previous vaccine distribution efforts due to its scale and urgency. These key factors will provide new challenges for pharmaceutical companies and the logistics companies that will support them. 1. Unprecedented Speed to Market Multiple COVID-19 vaccine development efforts are happening today at a swift pace; that is expected to accelerate throughout manufacturing and distribution. Unlike other vaccines such as the hepatitis, polio, or even the seasonal flu vaccines, test data on temperature excursions affecting the efficacy will be limited and the COVID-19 vaccines will have to be shipped under ideal conditions. Therefore, speed to market and maintaining cold chain integrity will be bigger considerations for all actors in

88 INTERNATIONAL PHARMACEUTICAL INDUSTRY

the supply chain than distribution cost or logistics efficiency. 2. Unfamiliar Shipping Networks The demand for the COVID-19 vaccine is not specific to a certain demographic or region, unlike traditional vaccines. Vaccine supply chain actors will be shipping to new customers through unfamiliar trade lanes, using new transporters, and using new shipment modes. Vaccines will be distributed to new or unfamiliar storage facilities, in geographies that may not be familiar with modern cold-chain management. The vaccine supply chain will be stretched to meet demand at a national, continental and global scale requiring multi-, inter-, and intra-modal means of shipping all without typical supply chain planning and evaluation periods. 3. Unmoderated Scale-up COVID-19 vaccines will require shipping at scale from day 1. Unlike traditional vaccine supply chains which begin with lower doses shipped to established regions, the COVID-19 vaccine will require full-scale manufacturing and distribution from the start. When combined with the use of unfamiliar networks, the amount of risk entailed in the process is multiplied. These unique challenges will force the industry to rethink traditional approaches to vaccine cold chain and shipment monitoring. COVID-19 vaccine manufacturers and shippers cannot settle for accepting

or rejecting goods upon arrival and they cannot rely on touchpoints in the chain of custody to provide information. They will need to act in real time, take pre-emptive measures and guide people downstream proactively. The Monitoring Approach Needs Fresh Thinking The COVID-19 vaccine supply chain requires a top-down monitoring approach that doesn’t rely on the touchpoints in the chain of custody for information. It requires real-time signals generated by the vaccine shipments which can be shared with all actors within the chain of custody, much like a reverse blockchain system for physical integrity. However, current vaccine cold-chain monitoring methods largely work in a bottom-up manner with many dependencies, making visibility time delayed, incomplete, or unverifiable. 1. Time-delayed Visibility Data loggers can track the temperature of a vaccine shipment accurately, but the data is typically collected only upon arrival. The captured data is manually uploaded in most cases, creating room for error that could impact the efficacy of the vaccine if some vials slip past the distribution chain. Even if the data is collected without lapses, its value is restricted to determining whether to accept or reject a shipment upon arrival; it cannot prevent a stockout as it cannot provide early warning signals.

Winter 2020 Volume 12 Issue 4


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Articles inside

The Challenge of Global COVID-19 Vaccine Distribution Demands a New Approach

16min
pages 96-101

How the War on COVID-19 is Driving Innovation in Temperature-controlled Packaging – and Beyond

12min
pages 92-95

COVID-19 Vaccine: Unique Distribution Challenges Call for a Unique Monitoring Approach

5min
pages 90-91

In Highly Regulated Industries your Labelling must Speak for your Product – Compliance is Non-negotiable!

6min
pages 82-85

Working Together to Beat the Drug Counterfeiters

10min
pages 86-89

Exploring Pharmaceutical Packaging’s Top 2020 Trends

7min
pages 80-81

HPMC and the Value of Vegetarian Hard Capsules

7min
pages 74-75

Managing the Mass-Production of Tablets with Efficient

8min
pages 70-73

Preserving the Parenterals of Tomorrow

9min
pages 66-69

Causes of Punch Tip Wear and How to Avoid Them

12min
pages 76-79

The Importance of Anonymised Unstructured Data in Advancing Medical Research and Patient Outcomes

11min
pages 40-43

Completing the Puzzle Technology in Decentralised Clinical Trials

9min
pages 56-59

Designing for Success: A Multi-stakeholder Approach to Clinical Development to Optimise Patient Access

14min
pages 44-47

What Is Preventing the Industry from Providing Electronic Product Information?

20min
pages 48-55

The Rabbit and the Horseshoe Crab

10min
pages 32-35

Powerful, Large-scale Analytics brings Single-cell Omics into Clinical Reality

12min
pages 36-39

Optimising Device Design for New Generation Biologics

7min
pages 24-25

Putting Translation Central to the MDR Shift

9min
pages 18-19

Editor’s Letter

4min
pages 8-9

Critical Challenges and Potential Solutions to Optimise Downstream Bioprocessing Production

11min
pages 28-31

The Heightened Case for IDMP in the Light of COVID-19

7min
pages 26-27

Truth Matters: Why Science Journalism Has Never Been So Important

5min
pages 16-17

Clinical Requirements under EU MDR: Understanding the Changes

17min
pages 20-23

Brexit White Paper

15min
pages 10-15
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