Risk versus Benefit

October 18, 2021 • Posted in Blog

Photo Credit: Olivier Le Moal

Janet Liljestrand, M.D., M.A.

unnamed (13)

Whether we realize it or not, we weigh the benefit versus the risk of most decisions, large and small. When making medical decisions, physicians will sometimes refer to the risk/benefit ratio. A math problem with numbers? Unfortunately not, but a clinical judgment seeking to determine if the benefit that this particular patient is likely to receive is greater or lesser than the risks the patient will be assuming with the procedure or medication.

Childhood immunizations risks are often stated to be less than one in a million. With such a low risk, the benefits are great by comparison. As a pediatrician for over 40 years, I have watched some illnesses nearly disappear because of the increased number of immunizations. However, for young parents, who see and hear much on social media, the benefits are not so obvious as they are to me armed with hard data and personal experience.

Enter the coronavirus pandemic. Children stayed home from school. Many of all ages became ill. Many persons died, especially the elderly, with relatively fewer children seriously affected. Vaccines were produced in record time with a technology, though not new, had not been used previously in the production of vaccines. These vaccines, under an Emergency Use Authorization (EUA), were used to immunize millions of adults with the hope of stopping the pandemic. Never have so many been given a vaccine that had not yet received full FDA approval. Had the cavalry arrived in time?

In spite of all efforts, the coronavirus is showing no signs of disappearing forever leading to increased efforts to immunize everyone. EUA for the vaccines has been given for children 12 and over and being sought for all children. At the same time, there are now reports of myocarditis and pericarditis (heart inflammation) predominately in older teenagers and young adults with the mRNA COVID-19 vaccines. How frequently is this? Does this occur with the disease and with what frequency?

Reports of heart inflammation and other adverse reactions to the COVID-19 vaccine are reported to the Vaccine Adverse Event Reporting System (VAERS) of the Centers for Disease Control and Prevention (CDC). This has been criticized because it is a voluntary system. However, most physicians are familiar with the system, reports can be submitted by anyone, and the reporting process is easy. What would a mandatory reporting system look like? What type of burden would be placed on those giving the vaccines (physicians, pharmacists, vaccine clinics)? Would that change the usefulness of the data?

As the vaccines are in trial and may soon have an EUA for younger children, parents and their physicians must weigh the risks of the vaccine and their potential benefit against the risks of the disease. How high a risk from the vaccine is too high? Would a risk of one in 200,000 (picking a number out of the air) be too high? Perhaps not in a pandemic with an easily transmissible disease. What we need now for younger age groups is good, reliable data not only for adverse vaccine events but also for serious consequences from the coronavirus itself. The disease may not have been with us long, but it has infected large numbers of people in all age groups. Where the death rate was high, the risk from the disease quickly became obvious. Where the death rate is low, but long-term consequences of something like myocarditis either from vaccine or disease are unknown, the risk/benefit ratio of the vaccine is harder to determine. Oh, for a ratio into which we could just plug in numbers.

The Tennessee Center for Bioethics & Culture encourages respectful discussion and debate of bioethics issues, and strongly supports freedom of speech. To that end, we invite and welcome other voices to the discussion of bioethics issues. Invited authors’ views are their own, and do not necessarily represent those of The Tennessee Center for Bioethics & Culture.


2022 Paul Ramsey Award Winner
C. Ben Mitchell, Ph.D.

The 2022 Paul Ramsey Award for Excellence in Bioethics goes to our Distinguished Fellow, C. Ben Mitchell. The Tennessee Center for Bioethics & Culture Board of Directors and Executive Director congratulate Dr. Mitchell on this honor: it is well-deserved.

Read the full announcement here.