The Crestone Eagle • November, 2020

A Doctor’s Notes Ensuring uptake of vaccine against COVID-19

by Earl W. Sutherland, III,

MD PhD

There is no question that the United States approach to the COVID-19 pandemic has been a disaster, almost entirely due to the failure of the president and his officials to lead with a coherent and effective national plan. Having passed management responsibility to the uncoordinated (chaotic) action of the states, all now may  depend on the widespread implementation of a safe and effective vaccine.

However, even this hope has been tarnished, leading to a recent poll finding that only 49% of Americans planned to get vaccinated against the novel coronavirus. “Herd immunity” is the community level of immunity where the level of infection is neither growing nor declining exponentially. For COVID-19, an air-borne droplet disease, the figure needed is 60-75% immune; for influenza, it’s 33-44%; for measles and pertussis (whooping cough), also spread by air-borne droplets, the figure is 92-95%.

So, if too many people refuse the vaccine the achievement of herd immunity could require mandated vaccination. (It had been suggested by a high-ranking physician in the administration that just letting the disease run would ultimately result in herd immunity.) Unfortunately COVID-19 seems to impose a 2-5% mortality, a number utterly unacceptable for vaccination, where the vaccine would have to cause negligible mortality to gain FDA approval. Too many people would have to die by the time we arrived at herd immunity.

An appraisal of many of the issues bearing on required vaccinations has been presented by, M.M. Mello, R.D. Silverman, and S.B. Omer (NEJM 383(14) p.1296-1299 (10/1/2020)). They propose six stringent criteria to be met before a state imposes a vaccine requirement, once an approved vaccine even exists:

1. There must be evidence that COVID-19 is inadequately controlled in the state as judged by suitable criteria. To impose on the autonomy of citizens, the threat of harm must be well defined. As time passes before the vaccine is available, we’ll know even better how to judge the gravity of an upsurge.

2. The question of who should be covered by the mandate has been studied by the Advisory Committee on Immunization Practices (ACIP) of the CDC. Its current suggestions for treatment are: the elderly, health professionals working in high risk situations (including nursing homes and patients with severe respiratory symptoms), persons with certain medical conditions, and persons working or living in high density settings such as prisons and dormitories. “Only recommended groups should be considered for vaccination mandate,” the authors report. But my reading of the reports is that the poor, Black, Latinx, and Native Americans are persons who, when infected, have the highest rates of death from the disease. Do you suppose they should be moved up near the head of the line?

3. While the FDA is the official agency for new vaccines, when it issues an Emergency Use Approval (EUA, which has been suggested in the case of current COVID-19 vaccines under consideration) this kind of provisional approval may be based on very limited data and the FDA’s decision consciously or unconsciously influenced by pressures to speed the product to use. Therefore, the authors of this article recommend that in addition to such an FDA EUA, the ACIP should also endorse any vaccines. The vaccine should not be a political gambit, but rather a well vetted, safe, and effective medicine.

An adequate supply of vaccine to cover mandated groups should be assured to avoid controversy and alienation if supplies are too limited.

4. Evidence for the safety and efficacy of the vaccine should be widely communicated. The advocacy of drugs subsequently proven ineffective have shaken confidence in the government information.

5. Financial and logistic barriers to vaccine access for those supposed to get it should be at near zero expense. Compensation programs for severe adverse effects from the vaccine should be pre-established.

6. Mandates should only be imposed after a time-limited trial of voluntary vaccine provision has proven unsuccessful.

Adoption and implementation of these suggested vaccine rules rest primarily with the states. One can imagine the variety of plans which could emerge, as judging from the current debacle, or no plan at all. I wonder if the states can even afford it. Shouldn’t there be a great deal of federal support?