COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities
Bardosh K, et al. BMJ J Med Ethics 2022;0:1–13. doi:10.1136/medethics-2022-108449
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In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31,207 - 42,836 young adults aged 18-29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm:
per COVID-19 hospitalisation prevented, we anticipate at least
- 18.5 serious adverse events from mRNA vaccines, including
- 1.5-4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation).
We also anticipate
- 1430-4626 cases of grade >3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation).
University booster mandates are unethical because they:
- (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group;
- (2) may result in a net harm to healthy young adults;
- (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission;
- (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and
- (5) may result in wider social harms.
We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support.
Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates.
CONCLUSION
Based on public data provided by the CDC,19 we estimate that in the fall of 2022 at least 31 207-42 836 young adults aged 18-29 years must be boosted with an mRNA vaccine to preven one Omicron-related COVID-19 hospitalisation over 6 months. Given the fact that this estimate does not take into account the protection conferred by prior infection or a risk adjustment for comorbidity status, this should be considered a conservative and optimistic assessment of benefit.
Our estimate shows that university COVID-19 vaccine mandates are likely to cause net expected harms to young healthy adults— for each hospitalisation averted we estimate approximately 18.5 SAEs and 1430-4626 disruptions of daily activities —that is not outweighed by a proportionate public health benefit. Serious COVID-19 vaccine-associated harms are not adequately compensated for by current US vaccine injury systems. As such, these severe infringements of individual liberty and human rights are ethically unjustifiable.
Mandates are also associated with wider social harms. The fact that such policies were implemented despite controversy among experts and without updating the sole publicly available risk-benefit analysis19 to the current Omicron variants nor submitting the methods to public scrutiny suggests a profound lack of transparency in scientific and regulatory policy making. These findings have implications for mandates in other settings such as schools, corporations, healthcare systems and the military. Policymakers should repeal COVID-19 vaccine mandates for young adults immediately and ensure pathways to compensation to those who have suffered negative consequences from these policies. Regulatory agencies should facilitate independent scientific analysis through open access to participant-level clinical trial data to allow risk-stratified and age- stratified risk-benefit analyses of any new vaccines prior to issuing recommendations.125 This is needed to begin what will be a long process of rebuilding trust in public health.
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See also VitaminDWiki
- Vaccination pages in VitaminDWiki 195 pages as of Dec 2022
- 2.3X increase in sudden deaths in Germany after start of vaccinations - Dec 2022
- Trivial difference between vaccinated and unvaccinated for cases, hospitalizations, and death - Nov 2022
- 400 doctors, scientists declare “international medical crisis” due to COVID-19 vaccinations - Sept 2022
- Regional Excess Deaths strongly associated with COVID vaccination rate (UK) – Sept 2022
- Develop a vaccine instead of a drug, less costly and no chance of being sued - Nov 2014