Technology

Pfizer’s coronavirus vaccine is FDA-approved. How the supply chain has been


The vaccine supply chain is ready to start delivery to inoculation sites after multiple tests in recent weeks and a planning effort that began this summer, according to Operation Warp Speed Chief of Staff Col. Eric Shirley.

“OWS is ready to begin distribution of those vaccines within 24 hours of that [emergency use] authorization,” Shirley said Tuesday in an interview with Supply Chain Dive.

The EUA arrived late Friday from the Food and Drug Administration, clearing the way for distribution of Pfizer’s and BioNTech’s coronavirus vaccine.

The authorization followed a Thursday meeting that concluded with a group of independent advisers to the FDA backing use of the vaccine.

“This is just the first step as the federal and state governments partner with the healthcare supply chain to mobilize a logistics undertaking unlike any this country has ever seen,” Chester Davis Jr., CEO of the Healthcare Distribution Alliance, said in a statement after the authorization.

If the U.S. is going to meet its goal of vaccinating the nation by the middle of 2021, it will require 16 million package deliveries to thousands of vaccination sites within 64 jurisdictions. It’s an effort that Shirley acknowledged “sounds daunting.”

A series of distribution tests

OWS began to hold working groups in the summer with distribution partners such as AmerisourceBergen, Cardinal Health and McKesson, Shirley said.

The summer meetings helped the government to understand the companies’ capacity and distribution networks. The Centers for Disease Control and Prevention provided a contract to McKesson for vaccine distribution following the meetings.

Operation Warp Speed has performed end-to-end pilot distribution to test the physical and digital delivery infrastructure.

Retrieved from Department of Defense on Dec. 11, 2020

 

Since September, OWS has held weekly table-top exercises to help practice the distribution of the vaccine with partners including McKesson, FedEx and UPS.

The distribution partners are also part of the daily operational calls, Shirley said.

“When the EUA comes, no one is having to reach out and have coordination meetings,” he said in an interview before the FDA’s approval. “By that point, it will be a very scripted, very highly refined distribution plan that takes effect.”

In recent weeks, OWS has taken this testing from the table-top to the real world, with end-to-end pilot distribution to test the physical and digital delivery infrastructure. An initial test run with Pfizer included 10 jurisdictions, which was expanded to more locations in another test last week. The tests have included assessments of Pfizer’s custom-made shipping boxes.

“As we continue to look at the stability data for Pfizer and they have continued to work on the distribution and packaging for their product, what we’re finding is that this cold chain requirement becomes entirely manageable,” Shirley said.

Tracking delivery to inoculation sites

The jurisdictions have told OWS leaders the addresses of their ultra-cold storage locations. The OWS technology infrastructure will let the leaders know when a location receives a vaccine delivery, and a dry-ice delivery will automatically be set for 30 days from that point.

“When you think about the volume … amount of actual product that’s going out, think about what happens each and every day with UPS and FedEx deliveries,” Shirley said. “It’s a very important delivery. But it is no more complex than taking physical distribution street addresses, confirming that there is a valid order into the VTrckS system, and delivering.”

VTrckS is the Vaccine Tracking System that allows the CDC to track the distribution of publicly-funded vaccines, according to the agency.

State health officials have also been planning for the roll out of the vaccine since the summer, according to Virginia Department of Health Director of the Division of Immunization Christy Gray. Virginia set up its vaccine…



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