CHAPTER 24

• Jurisdiction: United States

CHAPTER 24 PROBLEMS WITH DISTRIBUTION OF THE VACCINE

After the vaccine has achieved approval or has been given emergency authorization, how are vaccines distributed within the United States?

Conventional influenza and other vaccines are a typical commodity for routine commercial warehouse dissemination, sometimes with refrigeration controls required for the shipment. The 2020 evolution of new variants of COVID-19 and industry efforts to develop the means to repel the threats of the newly arrived virus, have expanded the duty of care for the handlers of vaccines. Food and Drug Administration rules for moving prescription biologic products require records of the doses that are handled, shipped, and being distributed.¹

The nature of vaccine distribution typically involves the warehouse shipment of pre-packaged vials to be injected into the arms of the recipients. There are exceptions. Oral administration of the polio vaccine (OPV) can be done easily and does...