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Pharma’s other challenge: COVID-19 vaccine distribution

Lisa LaMotta Editor-in-Chief, Risk and Regulatory, PwC US June 25, 2020

With COVID-19 vaccine preparations underway, concerns raised in May about potential materials shortages could be compounded as multiple different technologies are scaled up with differing cold storage needs for distribution and delivery.

The nature of the vaccine that emerges will determine distribution needs along the “cold chain” from manufacturing and temperature-controlled storage through packaging, transportation and ultimately, delivery by providers. 

Storage is a potential challenge in and of itself. Total refrigerated warehouse capacity is spread across the globe, according to the 2018 GCCA Global Cold Storage Capacity report, but concentrated in three countries, including the US. One estimate puts overall US availability at 15% of its capacity. Some of the vaccines in development for COVID-19 can be chilled at 2 to 8 degrees Centigrade, but others may require temperatures as low as minus 80 degrees Centigrade.

Among active vaccine candidates are traditional technologies (dead or live attenuated virus) as well as newer ones such as DNA- or RNA-based molecules. In addition to questions around the available quantity of supplies, the specifications of the ancillary products could differ based on the type of vaccine that is approved or authorized.

Some glass used to make vials is reportedly in short supply and could take months to bring to capacity; the timeline could be further tightened if two doses are needed to achieve immunity, though companies are working on plans for multidose vials to help compensate. Global firms are preparing to fill the need.

plastic or rubber material will need to be chosen for each vial’s stopper. This, too, could vary by vaccine modality, because the stopper can’t negatively interact with the final product. Besides vials and stoppers, a vaccine effort likely will need adequate needles to deliver the immunization, according to reports.

HRI impact analysis

HRI’s analysis of the different elements of the distribution chain suggest that some of the obstacles could be overcome or minimized and highlights the many stakeholders that will be involved in this global effort.

Some newly built facilities have added storage space; some may be able to handle cooler temperatures than others. Trucking operations that provide refrigerated transportation to the pharmaceutical industry also will have to meet vaccines’ specific needs, which may vary. Hospitals and retail pharmacies will need to consider whether they have appropriate refrigeration and freezer units, staffing and supplies.

States that collaborate on logistics can use communal supply hubs provided by governors to help coordinate what’s needed for distribution.

To smooth operations, industry stakeholders, including pharmaceutical and life sciences companies, may consider employing those tools along with additional public arrangements such as advance purchase commitments that reduce financial risk and other ways of working with regulatory bodies.

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