Vaccines present unique challenges to all participants in the manufacturing and distribution process. Vaccines are highly regulated products. Manufacturers must prove compliance with cGMP (contemporary good manufacturing practices) and must compile a complete electronic batch record for every unit of production. Inputs must be captured and recorded, and most importantly, a complete end to end cold chain must be established and maintained. Unlike other medications, vaccines require uninterrupted refrigeration from production through to the injection of the patient. For companies engaged in drug production and distribution this can be a major challenge.
Vaccines require a degree of management well beyond traditional goods. Temperature must be maintained and monitored throughout the distribution process. This requires investment in critical infrastructure including refrigerated containers, IoT based temperature and location tracking, data about ambient temperatures and exposure times, and significant analytics to track possible problems and excursions. Mistakes here can be costly in both human and financial terms. If a vaccine is not maintained at correct temperatures it may become ineffective in treating disease, and economically worthless to the buyer and seller.
Maintaining a cold chain in the context of global distribution can be a daunting task. Most supply chain participants lack the sophisticated tracking, monitoring, alerting, and reporting required to ensure that a safe and effective vaccine reaches the patient. Where the logistics providers themselves lack this ability, it must become part of the product itself. Sophisticated packaging, and containerized solutions must be provided to maintain rigorous control of the products temperature while in motion and at rest. Contextual data about location and ambient temperature must be available to successfully alert users of possible future excursions with predictive analytics. It is only through the application of IoT and AI to the supply chain that we can monitor and ensure that an effective dose reaches every patient in the world that needs one.
Time is running short for providers and vendors to ramp up these capabilities for their customers. In the US, it seems likely that shipments will start this fall. The US Food and Drug Administration will likely extend the Emergency Use Authorization to several products in phase three trials. These extensions can be approved if there is an urgent public health crisis that can or might be alleviated or mitigated by novel medications. Given the urgent nature of the public health crisis brought on by COVID-19 this authorization is likely to be granted. This seems especially likely as the current administration pushes for an available vaccine before the election. Pharmaceutical companies have already begun to ramp up production. Moderna is opening a new plant in Massachusetts and is already hiring production staff for all three shifts. Others are building capacity as well. For vendors, service firms and logistics companies looking to support this important market the build out has begun.