COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment

Source:

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4206070

Date Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 - 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

Note: Funding: This paper was partially supported by a Wellcome Trust Society and Ethics fellowship awarded to KB (10892/B/15/ZE) and Wellcome Trust grants to EJ (216355, 221719, 203132).
Competing Interest Statement: We do not have any competing interests to declare.

 7. Conclusion 

705 Based on public data provided by the CDC18, we estimate that approximately 22,000 to 30,000 

706 previous uninfected young adults ages 18–29 years must be boosted with an mRNA vaccine to 

707 prevent one Covid-19 hospitalisation. Given the fact that this estimate does not take into 

708 account the protection conferred by prior infection nor a risk-adjustment for comorbidity status, 

709 this should be considered a conservative and optimistic assessment of benefit. Our estimate 

710 shows that university Covid-19 vaccine mandates are likely to cause net expected harms to 

711 young healthy adults—between 18 and 98 serious adverse events requiring hospitalisation and 

712 1373 to 3234 disruptions of daily activities—that is not outweighed by a proportionate public 

713 health benefit. Serious Covid-19 vaccine-associated harms are not adequately compensated for 

714 by current US vaccine injury systems. As such, these severe infringements of individual liberty 

715 are ethically unjustifiable. 

716 

717 Worse still, mandates are associated with wider social harms. The fact that such policies were 

718 implemented despite controversy among experts and without updating the sole publicly 

719 available risk-benefit analysis to the current Omicron variants suggests a profound lack of 

720 transparency in scientific and regulatory policy making. These findings have implications for 

721 mandates in other settings such as schools, corporations, healthcare systems and the military. 

722 Policymakers should repeal booster mandates for young adults immediately, ensure pathways 

723 to compensation to those who have suffered negative consequences from these policies, 

724 provide open access to participant-level clinical trial data to allow risk- and age-stratified harm-

725 benefit analyses of any new vaccines prior to issuing recommendations125, and begin what will 

726 be a long process of rebuilding trust in public health.

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4206070

Preprint not peer reviewed