COVID-19 vaccines, a catalyst for evolution in the Pharma supply chain?

Most of the vaccines on offer for COVID-19 require two doses before they are effective, and the window for administering the second dose is both variable, depending on the vaccine, and short. This means that while two doses are identical in content, the second is more critical to deliver in time. Setting up processes to prioritise the second dose in clinics, thereby maximising coverage and minimising waste, has been an important problem to solve. Keeping customers up to date with supply issues will also be essential. Careful patient communications will help ensure that patients attend the centres for treatment.

Many of the new vaccines require storage at a much lower temperature than standard logistics networks are equipped to provide. This is due to their use of groundbreaking new mRNA transfection technology. It requires investment in ultra-low freezers, temperature-controlled boxes that use dry ice, and active temperature trackers. These all have interesting implications:

• Expensive equipment and restrictive conditions could limit market access to drugs. A centralised hub and spoke model of production and distribution helps the vaccines arrive at points of use with the longest possible shelf life remaining. But how will the UK’s Primary Care Networks, for instance, who are being asked by the UK government to design and implement local treatment programmes, handle this type of delivery? And how will medical staff in countries with fewer resources manage? Once there is a range of vaccines available, a comparative analysis of their requirements will aid effective distribution and access.
• The second question arises from the use of advanced temperature trackers. This level of active data provision and interrogation will be new to many - what do they do in the case of a deviation from the required temperature? If a temperature excursion occurs in a port of export, for example, the options are to deliver a faulty product - not acceptable - or send it somewhere for disposal, which requires handling and disposal licenses.
• These products will be key black market targets, so security measures compatible with these conditions also need to be created. In addition, robust data security protocols need to be inplace to mitigate the risk of hackers targeting the logistics network.

One benefit of investing in this infrastructure is that, while these are the first of these advanced, modern therapies to be provided on this scale, they will not be the last. This is an opportunity to set up an ultra-low cold chain for high volume, high demand products so that when the lower volume advanced therapeutics, such as gene therapies, of the future come to market less upfront capital will be required.

Considering the complexity of bringing these new innovative products to market, how can PharmaCos ensure markets and customers are ready to receive and administer the vaccines?

A baseline go-to-market model can be designed as a starting point, which can be adapted to address any market-specific nuances. These specific requirements can be identified by conducting a market readiness assessment, looking for capability gaps. Tailoring to markets helps reduce risk and can manage the demands of ultra-low cold chain transportation, distribution and storage. For example, a direct to point of care model may be preferred by a PharmaCo for quality and security assurance, but this model may not work in some markets.

Adding third parties into the supply chain introduces control and oversight risks, especially if they are introduced into the ‘last mile’, i.e. the final stretch of the product’s journey to the end user. Close and transparent ways of working need to be introduced with these third parties to maintain a comfortable level of control at regional and global levels.

Once the go-to-market model is defined, in-market teams and customers need clear guidance and communications on the required market operations and processes. Done properly, this helps ensure market readiness while reducing the workload of regional and global teams, who can dedicate their time to supply and demand across the network.

When a market goes live, effective, constant operational support is required to help in-market teams swiftly address customer issues and queries, as well as robust data collection tools to gather patient feedback and outcome data. This is necessary not only from a pharmacovigilance perspective, but will also provide valuable insight into the longer term immunisation capability of the vaccines.