Glenn Abood, co-founder and CEO of rfxcel, a supply chain track and trace systems provider, told us traceability technology can play a role in securing the cold chain, especially when the anticipated COVID-19 “vaccine surge” happens.
Identifying and tracking the path of such vaccines will be of great importance.
Cross border and regional distribution of COVID-19 vaccines will be necessary, and the greater the number of countries involved in the supply chain, the more complex the management and the greater the risks, he said.
The traceability specialist is seeing ever more and increasingly sophisticated threats to drug delivery. “The pharma industry, along with governments, have to be extremely vigilant in this regard. Counterfeiters, and smugglers are particularly attracted to pharma market due to the high value nature of the products manufactured.”
There is the possibility of counterfeit COVID-19 vaccines and that is something rfxcel can help the pharma sector defeat, but a more pressing challenge is on the table, he stressed.
“There is a concern around the fact that COVID-19 vaccines will need to be maintained at a certain safe-handling temperature, which, at around -18°C or below, is one of the lowest temperatures of any pharma product being shipped because of the biologics, the active ingredients, involved. So how do we make sure that from point of manufacturer to point of dispense that vaccine is handled safely? Temperature monitoring can help with this.”
On top of that issue, the limitations in existing cold chain and freight infrastructure globally is an increasing worry for stakeholders across the value chain, given the billions of COVID-19 vaccine products that will have to be shifted once their approval is granted, he noted.
Indeed, IATA, the international airline federation, last month outlined how the transportation of the COVID-19 vaccines would require more than 8,000 747 jumbo freighters.
“The logistics of it are quite a nightmare,” said Abood.
Visibility into the COVID-19 vaccine inventory levels will also be a priority for the authorities. “As the vaccine leaves the manufacturing plant and goes to a distribution center, officials will want to track it onward as to know which hospitals received it and in what volumes. Our accurate immunization monitoring product makes it possible to know what inventory levels are like, and it has automatic reordering capabilities so a hospital or a clinic does not run out,” said Abood.
He said rfxcel is working in collaboration with a number of governments on such logistical challenges.
Call for distribution task force
A weak supply chain can destroy the quality of a COVID-19 vaccine, stressed Dr Wouter Dewulf and Dr Roel Gevaers from the University of Antwerp and Frank Van Gelder, secretary-general, Pharma.Aero, a collaboration of air-cargo industry stakeholders.
In a recent industry note, they outlined how a faulty approach to the logistics chain can potentially partly nullify the feat of COVID-19 vaccine development.
“It is therefore high time to start preparations that look beyond just air transport from airport to airport only.”
They argue that the European Commission and national governments must establish clear protocols with the World Health Organization (WHO) in relation to requirements for the distribution of COVID-19 vaccines, including "the last mile" of vaccine delivery.
“We plead for the appointment of a task force with experts from the medical logistics and aviation sector now." They said the logistics industry can replicate the efforts of the global pharmaceutical industry in trying to get a vaccine developed, "as long as it is clear what the possible scenarios for protocols, timing, quantities and standards could be.”
Use of track and trace systems in pharma
Track and trace systems for pharma have wide take-up in the US and in Europe and are beginning to gain greater traction in Latin American markets, in Russia and in the Middle East, based on emerging country-specific requirements, said Abood.
Regulations in traceability have been evolving and have helped stimulate the growth of drug traceability systems in the pharma sector worldwide. Developers need to be able to demonstrate they have managed their supply chain correctly.
“Probably the first significant law that was passed was in 2013 in the US, the Drug Supply Chain Security Act (DSCSA), the aim of which was to ultimately get the pharmaceutical sector to begin tracking and tracking their products to try to prevent counterfeits from getting into the market and to give more visibility on recalls and those sort of issues.
“Shortly thereafter, the EU passed legislation - the EU Falsified Medicines Directive (FMD) - that began to take effect in 2019; similar regulation has been passed in Brazil, Russia, Saudi Arabia and other markets such as Jordan and India, while traceability legislation is in progress in other countries such as Japan,” said Abood.
Pharma is rfxcel’s largest market, while food and beverage is a relative new sector for the company, but one that is growing. “A third area we are focused on is the public sector - state, federal and local government. We have activities in relation to that in the US and the Middle East.”