As countries worldwide continue to ramp up Covid-19 vaccination, logistics issues related to the vaccine supply chain have been thrust into the spotlight. From incessant production delays to the lack of cold-chain storage equipment, and remote point-of-administration challenges, the world has never been so focused on the pharmaceutical supply chain.
Even though the majority of these cold chain quality issues have become increasingly public in recent months, they are not new to the industry itself. The WHO estimates that more than half of all vaccines shipped globally are damaged or wasted before reaching consumers.
Pharmaceuticals are prone to a plethora of environmental factors across all points of the cold supply chain, right from the point of manufacture to when they are administered at the doctor’s office. Mishaps can easily occur somewhere along the way without proper cold chain quality controls.
It is therefore of paramount importance that temperature, humidity, and other environmental parameters are consistently monitored and controlled to ensure optimal cold chain quality control. Left to their own devices, the consequences can be truly dire. Not only are assets worth billions of dollars and millions of lives are on the line, but those involved are also liable for hefty fines and other costly regulatory consequences.
What’s clear is that actionable Covid-19 cold chain quality control strategies must be in place to ensure vaccine safety, even as demand continues to outstrip supply across the globe. Today, we talk about what’s being done to ensure the safe, fast, and effective shipment and delivery of COVID-19 vaccines around the world.
Ensuring traceability: Kicking off Covid-19 vaccine’s journey on the right foot
Even as many countries grapple with new variants, healthcare providers, government officials, and other stakeholders remain adamant about vaccine traceability. They want to get a complete picture of the journey each vaccine batch goes through down the supply chain, from manufacturing to shipping to on-site storage.
It makes a great deal of sense because providing stakeholders with access to a verifiable trail of data helps build confidence in the safety and efficacy of the vaccines, which can dramatically boost the Covid-19 vaccines’ public perception, acceptance, and uptake, as well as battle widespread vaccine hesitancy and misinformation.
For those involved with the Covid-19 vaccine, product traceability has gone from competitive factor to must-have. Thankfully, vaccine makers, and global bodies like the WHO, have come up with universal GS1 barcode standards to ensure traceability. They require barcodes to encode the vaccine’s expiration date, the package’s lot number, and an identification code.
Here at home, the FDA has implemented regulations that require all vaccine packages to bear a two-dimensional barcode that makes available the Global Trade Identification Number (GTIN) information so that each vaccine batch and vial can be traced down to the final destination.
Vaccine producers, by themselves and in collaboration with their partners, are also rising to the challenge. Moderna, the Cambridge, Massachusetts-based mRNA vaccine maker, recently partnered with IBM to launch a traceability platform built on blockchain technology to help stakeholders stay updated about the vaccine batch’s current statutes.
From a cold chain quality control standpoint, it’s also essential for vaccine manufacturers to provide their clients with access to environmental monitoring data. The same can be easily achieved with the help of a network of cloud-based digital data loggers.
According to Dickson, these small electronic devices are the workhorses of vaccine condition monitoring, helping deliver access to real-time environmental data via an intuitive web-based interface that can be accessed anywhere, at any time, and from any device. In this way, governments can rest assured that the vaccines they receive have not been subjected to improper environmental conditions.
End-to-end traceability supported by verifiable quality control data can also facilitate communication throughout the supply chain. For instance, government health officials and jab administrators can prepare beforehand for potential delivery delays and surges.
In the end, vaccine manufacturers, carriers, and shippers can ramp up production and transportation efforts to meet demands and avoid any significant delivery delays. With these traceability measures in place, countries across the world can expect more efficient vaccine rollouts.
Dealing with last-mile Covid-19 vaccine logistics problems
The last mile has for many decades posed a unique set of challenges for the vaccine sector. For Covid-19 vaccines, in particular, making sure safe vaccinations are delivered to hospitals, doctor’s offices, and vaccination centers has proven more tricky than anticipated.
One of the biggest challenges is the environmental conditions in which most of the vaccines currently approved for Covid-19 must be kept. For example, the CDC requires that the mRNA-based Pfizer-BioNTech COVID-19 vaccine be stored at ultra-cold temperatures of between -80°C and -70°C to retain its potency.
Cold chain logistics ensure that all Covid-19 vaccine batches are stored and shipped intact to the last-mile destination, at which most environmental monitoring challenges start to creep in. It can be challenging to deliver vaccines in smaller packages to hospitals and healthcare practitioners while ensuring ultra-freezing storage conditions.
For one, vaccines are removed from dry ice, defrosted, and delivered in refrigerated boxes from last-mile delivery centers. From here, vaccine batches have a shorter shelf/storage life. Some end up being unusable after reaching their expiration date.
Exposure to unacceptable conditions can further shorten their shelf-life, or even worse, cause vaccine degradation. Luckily, this is where environmental monitoring equipment like digital data loggers comes into play.
Sensors integrated with the vaccine storage boxes help monitor temperature, humidity, and other environmental parameters. They also help detect variations in real-time and alert managers of any deviations that may comprise vaccine quality. This gives responsible personnel enough time to remedy the situation and save the vaccines.
As the world prepares to put the Covid-19 pandemic under control, the importance of cold chain quality control and condition monitoring is becoming ever more glaring. There’s no doubt that data loggers will continue to play an increasingly pertinent role in ensuring optimum vaccine environmental monitoring.