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 not require a trained health worker. Some vaccines for influenza are administered by nasal spray. Once inhaled, the influenza vaccine can stimulate mucosal sites throughout the body.

Several of the COVID-19 vaccines pose a unique challenge to disseminate because they can be vulnerable to weakened effectiveness if not kept at a very cold temperature. Thus, extreme care must be paid to the mechanical aspects of protecting the vaccine between production of the vials and inoculation of the patients.

Under the 2020 federal Project Warp Speed, logistics experts from the Army, as well as private logistics carrier experts, took control of the initial vaccine supplies for delivery to the states. States determined the sites and volumes for the end-phase deliveries of vaccines.

The patterns for COVID vaccine distribution in the states among multiple competing recipients have been determined by governors with input from their state health director, state Medicaid officer, and the governor's health advisors.

Some legal conflicts may arise with state vaccine distribution systems. State priorities may conflict with federal preferences and requirements. Conditions that may be placed on federal grants or free supplies of vaccine may constrain state options.

Not all potential vaccine recipients are willing to accept the offered vaccination. Elder care facilities house millions of elders whose immune systems would be vulnerable to an aggressive...