By Maria João Cruz, PhD, Research Analyst, Centre for Health Solutions, and Jose M. Suárez, Manager, Life Sciences Advisory
The COVID-19 pandemic has claimed over 1.1 million lives and infected over 45 million people worldwide, numbers that continue to increase.1 Alongside its devastating human impact, the pandemic has exerted unrelenting pressure on pharma and healthcare supply chains. COVID-19 has exposed the fragility of our medical supply chains, and highlighted their global inter-dependencies and vulnerability to shock. We have also experienced major challenges in the medical equipment supply chain, including manufacturing, transport and distribution of testing kits, personal protective equipment (PPE), and ventilators. However, these challenges pale in comparison to the huge task ahead of us in getting life-saving COVID-19 vaccines to people around the world, in record time, to halt the spread of this virus. Importantly, this will have to be done while maintaining production, distribution and administration of other life-saving therapies, including the seasonal flu shots, and other essential medicinal products.
Providing access to COVID-19 vaccines
As of 29 October, there are 213 vaccines in development for COVID-19.2 Of these, ten candidates have reached the last stage of clinical development before they can seek regulatory approval.3 This summer, the WHO, together with Gavi, and the Coalition for Epidemic Preparedness Innovations (CEPI), launched the COVAX initiative aimed at supporting the building and upscaling of vaccine manufacturing and supply capabilities to provide countries worldwide with equitable access to two billion doses by the end of 2021.4 In addition, governments around the world are signing agreements with leading COVID-19 vaccine developers to ensure early access for their citizens to vaccines that have proven to regulators that they are safe and effective.5,6,7,8 For example, the UK government’s Vaccine Taskforce, set up in May 2020, has now secured access to six different types of vaccine against COVID-19.9
While companies and countries are signing contracts and conducting exploratory talks, and despite encouraging data on safety and the immune response, it is still unclear which candidate will be approved first.10,11,12 Moreover, as we explored in a blog at the end of August, COVID-19 vaccine developers are using a variety of approaches, ranging from the tried and tested to completely novel platforms, which require different manufacturing and distribution capabilities.13 Nevertheless, companies with promising candidates are taking a risk and standing up manufacturing facilities and preparing a resilient and scalable vaccine supply chain in anticipation of approval. At the same time, COVAX is working with different manufacturers to provide investments and incentives to ensure that they are ready to produce the doses needed as soon as a vaccine is approved.14
COVID-19 vaccine manufacturing and supply chain challenges
Lessons learned from medical supply chain disruptions and experience in establishing COVID-19 testing infrastructures will be crucial to help governments, as well as pharma and logistics companies, prepare manufacturing and worldwide distribution of COVID-19 vaccines. However, unlike most medical equipment or tests, vaccines are perishable and highly sensitive to temperature fluctuations.15 In addition, even compared to other biologic drugs, vaccine production is very complex, albeit the extent of complexity varies depending on the platform used.16
Different vaccine approaches have different temperature requirements for packaging, storage, transportation and distribution. Vaccines need to be kept at low temperatures, with traditional vaccines typically requiring refrigeration within the range of 2 to 8°C, which means they require a cold chain with end-to-end temperature control.17 Readying a gigantic and robust vaccine cold chain is an imperative for governments, and pharma and logistics companies to be able to deliver these vaccines around the world, which is particularly difficult in warmer climates and remote locations.18
An important aspect of the current scenario is that two of the leading candidates are using an RNA-based technology approach, which, despite its ease of manufacturing and scalability, requires sub-zero temperatures for storage and transportation as low as -80°C.19 Even though RNA technology is being successfully used in the treatment of other diseases, such as amyloidosis20, no licensed vaccine has employed this approach. This means that the existing global vaccine cold chain has not had to work with such low-temperature requirements, especially at the scale that is now required. However, companies can use their experience with other therapy areas and technologies (for example, stem cell therapies) that require temperature-controlled supply chains to quickly ramp up capacity.
Logistics and pharma companies have announced that they are working hard to build capacity for frozen storage ahead of regulatory approval.21,22 Dry ice (solid carbon dioxide, which sublimates at −78.5°C) is seen as a potential viable solution to keep RNA-based vaccines frozen for a period of time during transportation and distribution without the need for on-board freezer-units. Companies developing these types of vaccines are still working to optimise stability at higher temperatures to ease the constraints on supply chains.23
For those COVID-19 vaccine front-runners that do not require sub-zero temperatures, their manufacturing and global distribution will still require unprecedented efforts. For example, inactivated virus vaccines (an approach being used by three of the leading candidates) require large quantities of infectious virus for their production, which poses a greater challenge on their manufacturing, and any failure in the refrigeration system across the supply chain would jeopardise their safety and efficacy.
Leveraging advanced digital technologies to bolster vaccine supply chain resilience
To date, we have seen an impressive array of collaborations and partnerships coming together in response to the pandemic. As the industry prepares for the global storage and distribution of vaccines against COVID-19, it is critical that these same stakeholders continue to work together to identify all possible logistics requirements and bottlenecks across the end-to-end supply chain, particularly under a more stringent cold-chain logistics scenario. In addition, as we have seen with PPE and testing kits supply chains, it will be crucial to ensure the integrity of vaccine manufacturing and distribution, especially to protect people from falsified and counterfeit versions.24 Some of the more innovative and digitally-driven supply chain solutions, such as blockchain technology, could help improve public trust and assurance over quality and safety.
As noted in our report Intelligent drug supply chain: Creating value from AI, artificial intelligence, blockchain and other advanced analytical technologies are poised to transform supply chains and manufacturing through real-time data processing and decision-making, with end-to-end visibility and traceability, as well as forecasting and predictive capabilities. In addition, cold-chain transportation technology needs to be integrated with real-time, end-to-end tracking software to ensure the effectiveness and safety of these vaccines when they reach their destination. We also highlight how robots and drones can play a major role across the COVID-19 vaccine supply chain, particularly in the distribution and delivery to the most vulnerable and/or more inaccessible geographies.
Given the complexity and hyper-connectedness of today’s global pharma supply chain environment, a digital, AI-enabled risk-sensing management strategy can help companies identify and sidestep obstacles that are avoidable and quickly adjust operations when faced with disruptions.
The pharma industry has been delivering vaccines worldwide for many years, so the expertise exists. However, the magnitude and additional complexity of the effort now required will need extraordinary collaboration between governments, NGOs, private companies and not-for-profit organisations, as well as with local customs officials and regulators.
There have also been many lessons to learn from disruptions in the pharma and medical supply chains since the onset of the COVID-19 pandemic, including the experience of many countries in building COVID-19 testing and PPE distribution infrastructures. These lessons have shown the importance of adequate planning, as well as of effective and efficient coordination and collaboration. Indeed, successful collaborations and partnerships will be critical to enable the worldwide distribution of vaccines, while building resilient supply chains that will help ensure that the world is better prepared for future global health emergencies.
Equally important will be realising the ambitions of COVAX, and especially listening to its coordinating member organisations, Gavi, CEPI and the WHO, all of who have extensive experience in resolving many of the logistics challenges highlighted above. If these lessons can be built on, then realising an effective vaccine distribution infrastructure may become a reality.
For healthcare systems across the world, it will also be crucially important to maintain robust records on the administration of vaccines, a subject we will return to in a future blog.