Pfizer Opting Out of U.S. Government Channels for COVID-19 Vaccine Distribution

Compiled by Hemingway

Recently, Pfizer explicitly stated that if its COVID-19 vaccine receives FDA approval, it will not require the U.S. government’s assistance for distribution. Instead of using McKesson, the government-selected distribution partner, Pfizer will deliver the COVID-19 vaccine directly to healthcare personnel through its own distribution system.

In late October, Pfizer announced an ambitious vaccine distribution plan, focusing on its manufacturing facilities in Michigan and Belgium. Given that mRNA vaccines must be stored at -94°F, the plan includes shipping containers capable of maintaining this temperature for doses sufficient to last 10 days. Additionally, the company has established storage sites in Wisconsin and Germany, among other locations.

Pfizer stated publicly that the distribution model agreed upon with the U.S. government is built on a flexible, just-in-time system that will ship frozen vials directly from manufacturing plants to vaccination sites. Consequently, distribution routes will run directly from Kalamazoo to points of use (POUs), or from distribution centers located in Pleasant Prairie, Wisconsin, to POUs and other locations at similar distances.

Because vaccines must be maintained at ultra-cold temperatures at all times, Pfizer must closely monitor its shipments. Accordingly, the company has developed real-time GPS functionality that reports temperature fluctuations in real time, and further optimization of the distribution system will reduce the risk of vaccine spoilage before reaching patients.

Due to the severity of the COVID-19 pandemic, Pfizer is under pressure from all sides to successfully launch its COVID-19 vaccine. With no interim data from Phase III trials yet available, the company has reached a $1.95 billion agreement with the U.S. government [Related Reading: $1.95 Billion! Pfizer/BioNTech COVID-19 Vaccine Secures Major U.S. Government Order] to supply up to 100 million doses of the BNT162b2 candidate vaccine, and Pfizer has committed to delivering 40 million of these doses by the end of the year.

This August, the U.S. government appointed McKesson Corporation to collaborate with the Centers for Disease Control and Prevention (CDC) in developing a distribution plan for COVID-19 vaccines. McKesson has some experience in responding to pandemics, having participated in vaccine distribution during the Obama administration in 2009 to combat the H1N1 influenza outbreak that year.

Cold-chain transportation poses a significant challenge for any distributor. It is not only Pfizer that faces this hurdle; Moderna’s mRNA vaccines must be stored at -4°C. However, Moderna has stated publicly that it will not seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) before November 25, as the company aims to ensure adequate preparation for the widespread distribution of its COVID-19 vaccine by next spring.

Reference Source: Pfizer Goes Solo on US Shot Distribution, Opting Out of Government Channels