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Jill Wechsler is Pharm Exec's Washington Corespondent
Experts fear confusion over allocation process, cold-chain requirements, IT systems.
As manufacturers advance Phase III testing of multiple COVID-19 vaccine candidates, industry and government authorities are focusing on the vast delivery, handling, and information systems needed to bring vital preventives efficiently to appropriate health care sites. Important complications are that some promising vaccines require two shots about three weeks apart and must be shipped frozen, one at sub-sub-zero temperatures. Additionally, it’s not clear how manufacturers, distributors and public health officials will deal with multiple approved vaccines and the possibility that a later preventive will be more potent than earlier shots.
In hopes of avoiding the confusion and mistakes that stymied access to diagnostic tests and personal protective equipment when the pandemic erupted six months ago, the administration’s Operation Warp Speed (OWS) has established an organization to oversee the delivery of COVID-19 vaccines, in addition to its more prominent role in funding the development of vaccines and therapeutics to combat the pandemic. A cadre of military logistics experts are monitoring production and planning for distribution of authorized medical products, headed by Gen. Gustave Perna, with support from the Centers for Disease Control and Prevention (CDC).
The OWS plan for vaccine production and distribution is outlined in its “From the Factory to the Frontlines” report to Congress issued Sept. 16, 2020. It notes that initial vaccine distribution will follow recommendations of the Advisory Committee on Immunization Practices (ACIP), which advises CDC on vaccination schedules and practices. ACIP’s recommendations will be shaped by a special panel formed by the National Academies of Science and Medicine (NASEM), which unveiled a framework Oct. 2, 2020, for a four-phase approach to COVID-19 vaccine allocation and distribution. The panel called for Phase 1 to cover approximately 15 percent of the U.S. population, including front-line health workers and first responders, followed by individuals with underlying health conditions that puts them at higher risk of severe disease or death. The NASEM advisors do not support early access for minority populations per se, but addresses the needs of disadvantaged groups by prioritizing early access based on health conditions and limited access to care.
Meanwhile, the CDC has provided advice to help state health departments update and expand vaccine distribution plans, a challenging task for local and tribal health departments charged with providing vaccines to priority populations. A CDC distribution contract with McKesson will handle initial vaccine deliveries from manufacturers to states and other jurisdictions.
Last mile complicated
While the logistics of the initial delivery process are relatively limited and straight-forward, later expanded distribution to multiple sites will be more complex. The real challenge, explained Nicolette Louissaint, executive director of logistics firm Healthcare Ready, is the “long, long dreaded last mile” within a state. The logistics really do differ, she explained at a briefing sponsored by the Alliance for Health Policy on Sept. 30, 2020, based on the population to be vaccinated and the facilities engaged. And vaccination of a broader U.S. population in later phases will involve supplying doses to pharmacies and private practices where most individuals receive medicines and care.
The early phase of vaccine distribution is expected to run through mid-2021, followed by phase two covering about 60-80 million essential workers and high-risk individuals. The experts don’t expect a sufficient volume of doses for the general U.S. population until mid-2022. Distribution systems will differ for a single dose vaccine, as opposed to two-dose products, where “it’s not just getting people to the pharmacy the first time,” Louissaint noted.
Challenging temperature control requirements for lead vaccines developed by Moderna and Pfizer/BioNTech based on mRNA technology will limit how and where such products can be shipped. The logistics experts advise clinics and hospitals not to purchase special freezers to hold such products, as many local distributors have such equipment. These early vaccines may have to be administered only by large hospitals and health clinics and involve more frequent deliveries of smaller supplies that can be administered before the product deteriorates.
Similarly, all parties face dealing with multidose vials that have to be used within hours of opening due to a lack of preservatives. The larger vials can be shipped and stored more efficiently, but administration may challenge many providers.
Even though CDC and most medical systems and distributors have advanced data systems for tracking vaccines, a main challenge will be integrating these and newly expanded federal IT programs designed to identify patients at risk and to track vaccine administration and individual responses. CDC is developing a new Vaccine Administration Management System (VAMS) to support existing state operations, with added capabilities for patient scheduling and supply management. But the new system is confusing, and integration may take some time.
Tracking a two-dose vaccination schedule adds to the difficulties. To ensure that individuals receive the right shots at the right time, vaccine resupply will have to occur within the allotted time frame, and information systems must track and record when an individual is vaccinated, with which product and where. Even for vaccines that require only one shot, it will be important to record every individual dose in order to identify any adverse events, patient illnesses, and the extent of immunity provided over at least two years.