Even while discussions swirl around whether any Covid-19 vaccine currently in clinical trials will receive an Early Use Authorization (EUA) from FDA, other groups are suggesting how the vaccines are to be allocated once they become available. The federal government has already designated McKesson as the lead distributor of vaccines (but other distributors, as well as mechanisms within the CDC and other federal bodies) will inevitably be involved. Then the question is: Who gets them soonest?
NIH and CDC (read, the White House) asked the National Academy of Medicine (NAM; a quasi-public group, part of the National Academies of Sciences, Engineering and Medicine) for a “discussion draft” in July, and the result was published on Sept. 1. That itself was an unusual step; CDC already has processes in place for developing such a plan, and experience with past pandemics. A group within CDC, the Advisory Committee on Immunization Practices (ACIP) will use the results of the deliberations for a final report, but in President Trump’s Washington, it’s hard to say how thoroughly that will be followed.
(One consolation for the beleaguered CDC as it tries to keep a handle on pandemic response: both co-chairs of the NAM committee are alumni of CDC.)
The recommendations from NAM, it says, seek to “maximize societal benefit by reducing morbidity and mortality caused by transmission of the novel coronavirus.” The document proposes a common-sensical, four-step distribution plan:
1. High-risk healthcare workers, first responders, people with significant comorbidities and older adults in congregate or overcrowded settings
2. Critical-risk workers (who might have high risk of infection), teachers and support staff, people with moderate comorbidities, older adults, people in homeless shelters and incarcerated people
3. Young adults, children, other (lower risk of infection) critical-risk workers
4. Everyone else.
NAM worked from ACIP assumptions that 10-15 million courses of treatment would initially be available. Step 1 gives preferential selection to healthcare workers and they would consume most of that initial availability. Step 1 overall represents 15% of the US population; Step 2, 30-35%; Step 3, 40-45%; leaving approximately 5% for Step 4.
There are some explicit and implicit assumptions in this ranking: clearly, it recognizes that most Covid-19 hospitalizations occur among elderly people. It is also based on the “poorly controlled outbreak” the US is experiencing. “Given the epidemiology of Covid-19 so far, it is reasonable to assume these underlying conditions will hold around the anticipated start of the US Covid-19 vaccination program. However, it is possible that the United States is able to substantially control the outbreak similar to situations in countries such as New Zealand. In that case, a prioritization approach that initially emphasizes transmission over direct protection from morbidity and mortality could be considered.”
While the report has considerable discussion of the poorer outcomes being experienced by minority groups, an explicit guidance to address them preferentially is not included. The need to vaccinate regardless of citizenship status is sound medical judgment, but the politics of that bear watching. It’s also an interesting set of value judgments that, for example, nursing home clients are in Step 1 while prisoners (who are equally if not more “congregate or overcrowded”) are in Step 2. Differences like these might be insignificant if more vaccine shipments quickly follow the first batches, but if there’s a months-long lag between deliveries, the social pressure will skyrocket.
The NAM committee members who wrote the report emphasize that it is a “discussion draft” for which commentary is solicited; however, that comment period ends on noon September 4, three days after the report was released. A final report will then be sent over to CDC and HHS; one can assume that a “final final” report will come from the White House.