How Microneedle Technology Will Reduce Vaccine Cold Chain Logistics

In seritech Posted

Vaccines remain one of the greatest developments of modern medicine. But to maintain efficacy, vaccines must be shipped, stored, and distributed within a recommended temperature range. This poses a challenge in delivering these essential medicines worldwide.

A recent SeriTech analysis by Head of Business Development Luisa Sugisawa and Analyst Bola Okanlawon examines how cold chain logistics impact the lifecycle of vaccines and temperature sensitive drugs. It provides an overview of the cold chain, explains transdermal microneedles, and highlights how they could revolutionize drug delivery. The report underlines a range of additional benefits this technology presents, from democratizing access to reducing waste. 

The first objective is reducing vaccine wastage.

What is the level of vaccine wastage?

The level of vaccine wastage is substantial. A report by the WHO estimated that over 50% of vaccines are wasted globally every year. “Wastage in unopened vials is usually attributable to cold chain and stock management problems and can be minimized,” adding “wastage in unopened vials is avoidable and should be treated as unacceptable.”

Cold chain shipping and storage are critical to the biopharmaceutical industry. Logmore reports that global cold chain logistics spending for this sector in 2017 was over $13 billion USD. An estimated 20% to 40% of biopharmaceutical products damaged before reaching the end user. 

The WHO report identifies another major cause of vaccine wastage: freezing. This most often results from ineffective monitoring systems and infrastructure weakness. It is no surprise, then, there are calls for improved systems to manage cold chain logistics.

The SeriTech paper notes that while globalization has brought cultures and communities together, barriers remain, particularly as related to cold chain logistics in developing nations. “The complexity of shipping highly perishable products takes time and coordination, and every delay can have negative consequences,” the report observes.

To read SeriTech’s analysis of cold chain logistics and how microneedle technology will improve delivery mechanisms, request a free copy HERE.

Solutions to combat unused and spoiled vaccines add more layers to an already complicated process. Inventory management strategies like the WHO recommended EEFO – Earliest Expiry First Out – offer a practical solution. Smaller vials may resolve the issue of unused doses compared to larger vials but come at higher costs and create more waste. The vaccine vial monitor (VVM) system of labels that change colour to indicate vaccine efficacy help with visual cues but add additional costs.

The longtail effects of cold chain logistics have greater impact in developing nations. Unreliable power grids and physical infrastructure challenges are compounded by difficulties delivering vaccines to rural regions require new solutions. 

The microneedle has the potential to change the landscape.

Can new technology dramatically reduce or eliminate cold chain logistics?

Microneedle technology offers a proven alternative to traditional vaccine delivery methods. Of the four main types of microneedles, it is widely agreed that the dissolving microneedle (dMN) is the most effective. To learn more about dissolving microneedles, read here or request a copy of the SeriTech report here.

The exciting news is that dissolving microneedles could reduce or eliminate the challenges facing cold chain for both transportation and storage. Microneedles will reduce shipping and storage costs creating a knock-on benefit in delivering medicines to the public.

Dissolving microneedle patches for transdermal drug delivery are small and light when compared to the physical vaccine setup of vial and hypodermic needle. They are easier to ship and store, and easier to administer. Most dMNs can be produced with the vaccine in a dry state. Combined with suitable long-term stabilizers, they are not as sensitive to temperature variations.

In an earlier article, we discuss how a “dissolving microneedle can safely and economically deliver vaccines and other medicines, resolving a host of logistics issues while democratizing global access.”

What are other benefits of dissolving microneedles?

While reducing or eliminating cold chain logistics is important, there are other important benefits dissolving microneedles bring to the equation: simplicity, safety, painless delivery, and reduction of bio-hazardous waste. Embracing microneedle technology could also help reduce emissions associated with cold chain logistics.

Research indicates that dMNs have greater thermostability and a long-term evaluation of a dMN loaded with influenza vaccine “shows that influenza vaccine formulated into microneedle patches remained stable after storage for 24 months at 25°C, storage for four months at 60°C, exposure to five freeze-thaw cycles and irradiation during electron-beam sterilization.”

Vaccine wastage from unused doses is another issue that microneedles resolve. A Dutch study concluded “dMN vaccination can offer important advantages such as dose sparing, pain-free immunization and avoidance of needle-stick injuries. Furthermore, it can extend the vaccination coverage in developing countries by potentially offering improved vaccine stability, reduction of vaccine wastage and of burden on trained personnel.”

Dissolving microneedles patches for transdermal drug delivery eliminate bio-hazardous waste disposal issues of hypodermic needles and associated needlestick injuries. As SeriTech has observed, “safe disposal of needles presents a significant and costly challenge.”

Dissolving Microneedles for Vaccines

In their paper, Sugisawa and Okanlawon highlight 20 vaccines currently available to protect against disease. These prevent millions of deaths every year. Amidst a global pandemic, a growing number of Covid-19 vaccines will be added to this list. 

The storage temperatures required for some of those vaccines are the most demanding. Maintaining temperatures as low as -75C from manufacture to injection is problematic. The carbon footprint is significant. Microneedles could set the elements of a fundamental change in motion.

Since the first smallpox vaccine campaigns of the 1960s, shipping and storage has been a crucial piece of the puzzle. Dissolving microneedles could radically change how these vaccines are shipped and administered, resulting in positive impacts for developing nations.

To read SeriTech’s analysis of cold chain logistics and how microneedle technology will improve delivery mechanisms, request a free copy HERE.

Familiar images of vaccine delivery in developing nations show trained staff loading a cooler full of ice and vaccines on a motorcycle and heading out into the country to injection sites. Those doses must be used before degrading, creating a race against time and temperature.

Dissolving Microneedles for Vaccines in the Race Against Covid-19

The SeriTech authors observe “the global cold-chain logistics is capable of distributing around 6.4 billion flu vaccines per year.” That is based on what we once considered normal – now an outdated concept. In the context of Covid-19, the urgency for new technology that makes vaccine delivery easier and faster is paramount. And as we learn that booster shots will be required to maintain protection against the virus, this urgency is amplified.

Recent examples of freezer failures in developed nations highlight the instability of systems and infrastructure. Developing a new delivery mechanism to overcome the 150-year-old syringe in the race against Covid is now more important than ever before.

How Will Microneedles Change Vaccine Delivery?

Microneedles will change vaccine delivery in the 21st century by providing a safer, simpler solution. They will reduce dependency on cold storage and result in more effective delivery campaigns globally. This will be of particular importance in developing nations.

Consider this extensive WHO checklist and training requirements regarding the Global Training Network on Vaccine Management (GTN/VM):

  1. Inventory and Forecasting
  2. Stock control
  3. Distribution
  4. Storing and handling of vaccines
  5. Long term replacement
  6. Standard procedures for use of vaccines in immunization programs
  7. Monitoring systems for vaccine storage
  8. Transport management
  9. Operational Management

As Luisa Sugisawa observed: “It’s time to re-think vaccine delivery. Embedded at every level is temperature control and trained personnel. We believe that dissolving microneedles for vaccine delivery have the potential to diminish dependency on the former and reduce requirements for the latter. Our next phase is to deliver this vision globally.”

Without strict temperature controls, management programmes become easier to implement and administer. There will be less loss and more widespread, efficient delivery.

SeriTech: A 21st Century Vaccine Vision

Vaccine delivery using dissolving microneedle is poised to become the poster child of future vaccination. SeriTech is developing a safe, effective, and affordable alternative to democratize vaccination globally.

The company is developing commercial products leveraging a unique technology of fast detaching dissolving microneedle (fddMN) and is conducting extensive R&D into pharmaceutical applications, including vaccines. The soon-to-be commercial products of SeriTech, with the fast detaching dissolving microneedle are easy and painless. A two-minute application time sets a new benchmark. No painful needles. No biohazardous waste to dispose of. Safely and effectively delivering vaccines everywhere to every person.

When was the last time you saw a kid smile during inoculation? The next generation image of vaccine delivery could simply be an authorized person applying a 2-minute, painless patch on the arms of smiling children.

SeriTech aspires to making this image reality.

To read SeriTech’s analysis of cold chain logistics and how microneedle technology will improve delivery mechanisms, request a free copy HERE.