COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities
Developing vaccine policy requires that we carefully weigh the risks posed by vaccine to the recipient against its benefits, both to the recipient and to the community. Bardosh et al. set out to consider the ethical questions associated with COVID booster mandates, but the risk/benefit assessment (RBA) on which they base their discussion contains multiple flaws which all bias results against use of the vaccine. Specifically, their RBA:
Ignored Benefits from the Booster:
- Reduction in symptomatic disease
- Reduction in chronic disease (Long COVID)3
- Reduction in mortality
- Reduction in transmission
Assumptions Which Limit Magnitude of Benefits from the Booster:
- No advantages from the bivalent booster
- No benefits from boosters after six months
Cherry Picked Studies and Data:
- Ignored the results of an RCT in a study of SAE’s
- Considered only 3 cases from that RCT
- Ignored morbidity risks in the control group for reactogenicity
- In considering a large, multi-site study of myocarditis related to the vaccine conducted by the CDC.
- Only included data from the site with the highest reported risk estimate.
- Ignored data from other sites with lower risk estimates
- Ignored a large Israeli study of myocarditis/pericarditis.
- Included a small study from Israel with a much higher risk estimates than the ignored study.
All 13 errors artificially inflate the risk/benefit ratio. There is a 1 in 10,000 chance that 13 random errors would all increase the risks or decrease the benefits. Use of such a biased RBA raises its own set of ethical concerns.
This paper would simply be an unfortunate bit of public health history if its authors did not include FDA director, Marty Makary, Vinay Prasad, Tracy Hoeg, who will lead the agency’s vaccine evaluations.
Annotated Paper
