March 1, 2020

COVID-19 vaccine safety

With the world on pause for months, the question on everyone's minds has been, when will we get a vaccine for the coronavirus? From the USA to Russia, countries have been in a race to create this vaccine. There are currently 169 different vaccines being worked on with human trials for 26. However, even as the brightest minds in the world research and experiment these vaccines, statistics show many people have reservations about any possible vaccine.

The past months have shown the logistics industry that the vaccine will likely require very delicate shipping and storing conditions, as the solutions being developed have to be kept in temperatures as low as -80°C (-112°F). 

The new scale of deep freeze logistics obviously poses a challenge for global supply chains, which are not accustomed to such low temperatures on such a large scale. Needless to say, monitoring these temperatures is crucial for both the shippers and their customers.

To tackle the new challenges, Logmore has developed a solution for monitoring the deep freeze temperatures maintained by using dry ice. Suitably named “Logmore Dry Ice”, the new logger allows simultaneous monitoring of a shipment’s internal and external temperatures.

What are the temperature needs for vaccines?

Vaccines in general fall into three categories when it comes to temperature. First, you have the ones that need low but not freezing temperatures. That is usually between two to eight degrees Celsius. Second, come the vaccines that need to stay frozen in transit at around minus 20 degrees Celsius. Third are the ones like COVID-10 vaccines that require deep freeze conditions at minus 80 degrees Celsius, which is the hardest to maintain.

Depending on what category a specific vaccine falls under and its active ingredients, the storage conditions and equipment will change. When you're mass-producing and supplying a vaccine in a global pandemic, the supply system plays a massive role in how safe a vaccine is for consumers. 

The logistics of meeting these needs from production through transportation will need high-quality systems until administration. And despite President Trump's claim of an April vaccine, his own advisors caution that any such medication may not be available to the public until mid-2021 at the earliest. 

Which vaccine is available in 2021 is a debate that currently has no answer. Multiple companies are developing and testing their prototypes. In fact, part of the reason systems of distribution cannot be developed is because we don’t know what standards we will need to maintain. Each vaccine has its own criteria and ingredients.

Which vaccines are likely to be available?

There are three front runners in the vaccine production that have reached the phase 3 trial stage. 

  1. Moderna and the National Institutes of Health have created a genetic material-based vaccine that requires a deep freeze of minus 20 degrees Celsius to keep from breaking down.
  2. Pfizer and BioNTech also have a similar product that needs a constant minus 80 degrees Celsius temperature, or it falls apart. 
  3. A comparatively less high-maintenance vaccine by AstraZeneca and Oxford University needs to stay cold but not frozen.

But these are just a few of the hundreds of vaccines that are being produced the world over. Only once a vaccine has been proven to work and put into production can the details be explored. For example, a vaccine that requires only a cool climate will need very different systems than one that requires sub-zero temperatures.

Challenges for the future

  1. Multiple vaccines

When it comes to dealing with the coronavirus, there are multiple challenges. But the main issue is the lack of clarity or timeline. We don't know when the vaccine will be available or where. Depending on the region of origin and the destination, manufacturing and distribution will vary; it's impossible to create specific systems right now. 

There's also the possibility that multiple vaccines will come into the market together with customers having no way of knowing which is better. That means multiple suppliers and producers shipping separately to different regions with vaccines having different prices and quality control standards. If customers are confused about what they’re getting or how safe it is they may choose not to use the vaccine altogether.

One thing is looking to be certain: the different vaccines will require different conditions, so choosing a monitoring system that suits them all is necessary. Consistency is key for all related logistics.

  1. Temperature maintenance

While the specific temperature requirements will vary depending on which vaccine makes it to the forefront, one thing is certain: the need for freezing and cooling systems. As health officials struggle to figure out how to set up these systems, the need for multiple outside contractors becomes apparent. Every step of the process, from planes to warehouses, will need top-of-the-line freezers. The sheer volume of dry ice required will grow exponentially. Not to mention a large amount of temperature maintained storage space required.

But a solution may already be available. Food and pharma logistics companies already deal with the large scale monitoring of temperature and humidity levels for perishable and sensitive items. Ensuring the highest quality control level is a simple case of applying the systems these companies use to COVID-19 vaccines.

  1. Dry ice

The possible shortage of dry ice in the future will make maintaining temperature for the vaccine impossible. This is such a huge issue because there is already not enough of this key ingredient to meet the current demand. As a side effect of the pandemic, there has been a shortage of dry ice.

The dry ice comes from the carbon dioxide released during ethanol production. Ethanol, in turn, is produced as a result of gasoline processing. But, since the pandemic forced people to stay in their homes, there wasn't as big a demand for gasoline. So there was a domino effect impacting the production of ethanol. Despite the curfew having lifted, the ethanol industry is still facing a significant shortage. And this will have a big impact on the dry ice production in the months to come. Big companies like UPS and FedEx have started their own dry ice warehouses to preemptively prepare for the coronavirus vaccine.

Few data loggers are suited to monitoring products stored in dry ice. As a solution, the new Logmore Dry Ice logger is especially designed for this purpose.

  1. Packaging

Additionally, the packaging itself is also a concern. Since the doses need to be distributed in vials, it isn’t enough to place them in freezers. The vials themselves must have temperature monitoring systems. Here there is an option between passive and active containers.

Companies like Softbox and SkyCell provide passive packaging that can maintain preset temperature ranges. Depending on the needs of the final vaccine, the final temperature requirements may or may not fit the criteria. Alternatively, active containers from Envirotainer, DoKaSch, and CSafe can be set to meet any temperature requirements. With these, distributors can set the controls depending on the needs of the vaccine.

The current worry is that once the vaccine becomes available, these containers may quickly run out. Despite the increase in production to meet the needs of the coronavirus vaccine there simply won’t be enough to maintain supply worldwide. Eventually, companies will run out of proper containers. Or the price will become too high for people to afford. And when they’re unable to fulfil the high standard of quality control companies will begin to bypass these essential steps handing out vaccines that have not been properly refrigerated.

  1. Shipping

Currently, PPE is being shipped globally in massive quantities using air freights. To save money many companies are trying to shift their PPE shipping to ocean travel. Add this to the increasing number of countries producing PPE and you get a high number of masks available for a low price. 

However, this doesn’t mean companies have stopped distributing by air. The transition is slow. And even if there were an effort to shift over to ocean transport completely it would take many months. As a result, there are concerns that PPE shipping by air and COVID-19 vaccine shipments may end up competing for space.

Estimated volume of global Covid-19 vaccine needs is likely to boom in 2022.

What areas will have difficulty getting access to the vaccine? 

When considering the coronavirus vaccine, storage is a short-term concern. Because the demand is so high, the doses will be shipped directly from the manufacturers to the consumers. There is no need for long-term storage because it's going to be used immediately. Generally, most vaccines don't have a long shelf life because they are intended for quick use. Usually, it takes around 96 hours from lab to user, but the coronavirus vaccine will likely have an even shorter time span than this. Any products will be put to use right away, as so many people are in critical condition.

According to WHO and other research sources, it's generally known that getting the vaccine to people in Africa and some parts of Asia will be hard. The developing world will suffer since they may lack the facilities for cold storage. Private groups like the Gates Foundation and USAID are looking into ways to improve the outlook for patients in these regions. 

What's especially challenging is that the US and Europe are funding drug companies that are working on these vaccines so they will get access first. With estimated production at around 150,000 doses daily, it will take a lot of time to build up to 8 billion. During that time, the developed world will likely build safety protocols and distribution chains first, while developing countries will be the last to gain access.

The role of cold chain tracking

It isn't enough to create a vaccine. With the need for global distribution, data collection and analytics have never been more necessary. The mass production and supply mean there's a huge possibility for loss, theft, and damage. In addition to constant monitoring of the temperature controls and product quality, security and tracking are equally important.

Companies need to know exactly where their batches are at any given point, as well as, what storage and temperature conditions. They need to monitor to ensure that the highest quality and standard is being maintained for safe use of the vaccine and that no one steals the valuable product.

Cold chain tracking means having barcodes or QR codes for every single product. With a single scan, you need to tell where the product was made, who transferred it and who received it, and the dosage and batch number.

At present, the logistics industry lacks the necessary infrastructure or systems to handle such a huge cold chain of supply and demand. Even the serialization used is not the same worldwide. This is the first time there has ever been a need to store data on such a massive scale. We're talking about tracking ingredients, dosage, packaging, vials, needles, batches, temperature data, and patient information. This kind of massive scale inventory system has never happened before; naturally, there will be hurdles along the way. Maximizing the efficiency of these protocols has never been more critical.

The sheer magnitude of the task

While it's true that the world has faced pandemics and plagues before, the circumstances were very different. The globalization that exists today is a recent change. Never before has humanity tried to create and distribute a product to every single person on the planet. If we assume a 70 per cent level of herd immunity, that adds up to 230 million doses to immunize every American and 5.25 billion doses to vaccinate the world

Then there’s the added risk that the vaccine may not work as intended or maybe weaker than planned. What happens to these numbers if we need two vaccines per patient? How drastically will that affect the production processes? Part of the reason we don’t have a vaccine already is that governments can’t afford to back the wrong player. 

If you put all your money into one vaccine and it doesn’t work that sets the entire process back months. And does drastic damage to the economy and the progress towards creating a cure. Caution is necessary, but too much caution and governments and citizens alike will end up sitting around twiddling their thumbs while people die. It’s an impossible situation. And for the most part, there’s nothing to do but wait it out. 

Overall, the major safety concerns have to do with the maintenance of temperature control standards during shipping. If a system for this is put into place all other issues will be easy to solve. Governments and companies need to focus on how they’re going to distribute the vaccine after it is made.

Book a 30-minute call to learn more about how Logmore's solution can help secure your vaccine supply chain.