COVID vaccine distribution plan ignores NASH patients

The CDC COVID-19 vaccine distribution plan likely ignores NASH patients

The CDC is working on a plan for distribution of the COVID-19[1] vaccines once they are approved.  While I am sympathetic to how difficult the challenge is, I’m frustrated that their analysis mostly ignores liver disease patients with NASH. The ACIP COVID-19 Vaccines Work Group slide deck provides a look at how the government is planning the distribution of these critical vaccines.

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The strategy which affects the patient community in particular is called 1C.  This group would get vaccines after healthcare workers, long term care residents, and essential workers.  The proposed 1C group would be defined as over 65 or someone with a high-risk medical condition. Since that designation covers well over 100 million people one might think of it as “the rest of the population”. When you consider that the healthcare and essential workers groups are estimated to be 21 and 87 million the proposed “high-risk” groups are fairly far down the priority list.

Conceptually, we support a plan to minimize death while keeping the basic functions of society running. We seek to balance frontline risk, the needs of society, and individual hazard in a rational way.  When we deal with questions that are ultimately life and death it gets very complex with competing needs and value systems.


The currently proposed plan is not ideal and is based on limited data. Our specific concern is that the risks associated with the epidemic of undiagnosed liver disease is largely ignored.  In CDC statistics NAFLD/NASH are lacking because the medical community does not proactively identify NASH absent symptoms. The result is that NASH is not accurately represented in the statistics about comorbid conditions for which COVID-19 is dangerous. The reason that matters is illustrated by a recent study by Sarah Ghoneim et al [2]. That study looked at the risk of COVID infection by various elements of metabolic syndrome and NASH. These odds ratios are calculated compared to a healthy person. 

COVID-odds-ratio.JPG

Note that obesity, which is recognized by the CDC as a high-risk condition, is a 6 in this study.  Interestingly obesity is higher than diabetes at 5 but NASH is vastly higher at 14. This extreme risk is not recognized by the CDC and has only recently appeared in the literature as a result of the long-term failure to report the condition.

I suggest that If we look at the data in a different way, we can produce an effective vaccination campaign with fewer deaths. When we look at the risk profile, it is clear that age is a key determinant as shown in this CDC chart of mortality by age group. We should be aware of key drivers of that process.

death_rate_per_CDC.JPG


Clearly, there is a rapidly increasing risk starting at about age 40. We know that even though NASH is viewed by the medical community as a looming crisis, because of the lack of testing, it is not recognized as such by the CDC for the COVID vaccine even though it is the 4th leading cause of death in the 45 to 54 age group as shown in their own statistics.

death-rate-by-age.JPG

Devising a plan to best meet the needs of society is vastly complex.  As an at risk patient community that is largely ignored, situations like the repugnant policy that values cannabis workers above people with chronic illness is offensive.  Every possible plan is burdened by elements that are not ideal but if we focus on avoiding death as the prime directive the result is ultimately the most ethical and has the added benefit of being more effective by reducing morbidity. We submit that NASH should be included in the priority group.


Look carefully at the chart below by Angulo et al[3]. It ranks the mortality risk of the 4 stages of NASH against other common problems.  Note that F1 is higher than diabetes and F2 is higher than smoking. Both of them are considered to warrant vaccination for COVID but NASH does not. We believe that is wrong.

fibrosis-predicts-survival.JPG

It is our view that NASH should be listed as one of the initial triggers for COVID vaccination.

 

  1. McClung, N., et al., The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020. MMWR Morb Mortal Wkly Rep, 2020. 69(47): p. 1782-1786.
  2. Ghoneim, S., et al., The incidence of COVID-19 in patients with metabolic syndrome and non-alcoholic steatohepatitis: A population-based study. Metabol Open, 2020. 8: p. 100057.
  3. Angulo, P., et al., Liver Fibrosis, but No Other Histologic Features, Is Associated With Long-term Outcomes of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology, 2015. 149(2): p. 389-97 e10.

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