HHS releases some preliminary planning documents with worrisome gaps
With the clock ticking on when a vaccine might be available (and a president eager to make something happen prior to the Nov. 3 election). HHS has posted two documents and an infographic that it says constitutes “a strategic distribution overview along with an interim playbook.” It needs work.
Many of the operational issues have been set in place already with practices managed by the Centers for Disease Control (CDC); there are “jurisdictions” CDC manages across the country, along with a variety of tribal and territorial programs that are managed separately. CDC also has a Vaccines for Children program (which has managed the distribution of childhood immunizations for years); local administrators of those programs need to get a plan presented to CDC by Oct. 16. CDC also has VTrakS, an IT system for managing vaccine distribution, and IIS, the Immunization Information System, for collecting administrative data on patients.
The White House’s Operation Warp Speed has already contracted for millions of dosages to be produced, which will be sitting in warehouses awaiting FDA approval. Once approved, distribution will be “immediate;” McKesson has been contracted as the primary conduit for this step. One HHS announcement notes that McKesson “can cover rapid distribution of doses of refrigerated (2-8°C) and frozen (-20°C) vaccines;” however, the interim playbook notes that some vaccine might require -70°C storage and shipping, which might “be shipped directly from the manufacturer to the administration sites.”
Administration kits containing needles, syringes and disinfectants will be distributed separately.
The interim playbook also recommends that “jurisdictions are not advised to purchase ultra-cold storage equipment at this time. Ultra-cold vaccine may be shipped from the manufacturer in coolers that are packed with dry ice. These coolers should be repacked with dry ice within 24 hours of receipt of shipment and repacked again within 5 days.” Maintaining such a level of product preservation at local pharmacies or rural health centers is a difficult proposition; so is a manufacturer coordinating such a process.
Who’s first in line?
The big question will be in what order Americans will stand in line for receiving the vaccine. The National Academy of Medicine gave some guidance last week; the interim playbook doesn’t quite follow its details. Everyone agrees that healthcare professionals should be first in line (that’s an estimated 17-20 million) in a possible Phase 1-A; Phase I-B, however, is another 60-80 million “essential workers;” >100 million “high risk” individuals (generally, with pre-existing conditions); 53 million Americans over 65 (including 3 million in long term care). Even with overlapping categories and the midpoints of those ranges, adding them up amounts to half of American population. Phase 2 and later will be everyone else.