Background: Vaccine mandates and vaccine passports (VMVP) for SARS-CoV-2 are thought to be a path out of the pandemic by increasing vaccination through coercion and excluding unvaccinated people from different settings because they are viewed as being at significant risk of transmitting SARS-CoV-2. While variants and waning efficacy are relevant, SARS-CoV-2 vaccines reduce the risk of infection, transmission, and severe illness/hospitalization in adults. Thus, higher vaccination levels are beneficial by reducing healthcare system pressures and societal fear. However, the benefits of excluding unvaccinated people are unknown. Methods: A method to evaluate the benefits of excluding unvaccinated people to reduce transmissions is described, called the number needed to exclude (NNE). The NNE is analogous to the number needed to treat (NNT=1/ARR), except the absolute risk reduction (ARR) is the baseline transmission risk in the population for a setting (e.g., healthcare). The rationale for the NNE is that exclusion removes all unvaccinated people from a setting, such that the ARR is the baseline transmission risk for that type of setting, which depends on the secondary attack rate (SAR) typically observed in that type of setting and the baseline infection risk in the population. The NNE is the number of unvaccinated people who need to be excluded from a setting to prevent one transmission event from unvaccinated people in that type of setting. The NNE accounts for the transmissibility of the currently dominant Delta (B.1.617.2) variant to estimate the minimum NNE in six types of settings: households, social gatherings, casual close contacts, work/study places, healthcare, and travel/transportation. The NNE can account for future potentially dominant variants (e.g., Omicron, B.1.1.529). To assist societies and policymakers in their decision-making about VMVP, the NNEs were calculated using the current (mid-to-end November 2021) baseline infection risk in many countries. Findings: The NNEs suggest that at least 1,000 unvaccinated people likely need to be excluded to prevent one SARS-CoV-2 transmission event in most types of settings for many jurisdictions, notably Australia, California, Canada, China, France, Israel, and others. The NNEs of almost every jurisdiction examined are well within the range of the NNTs of acetylsalicylic acid (ASA) in primary prevention of cardiovascular disease (CVD) (≥ 250 to 333). This is important since ASA is not recommended for primary prevention of CVD because the harms outweigh the benefits. Similarly, the harms of exclusion may outweigh the benefits. These findings depend on the accuracy of the model assumptions and the baseline infection risk estimates. Conclusions: Vaccines are beneficial, but the high NNEs suggest that excluding unvaccinated people has negligible benefits for reducing transmissions in many jurisdictions across the globe. This is because unvaccinated people are likely not at significant risk — in absolute terms — of transmitting SARS-CoV-2 to others in most types of settings since current baseline transmission risks are negligible. Consideration of the harms of exclusion is urgently needed, including staffing shortages from losing unvaccinated healthcare workers, unemployment/unemployability, financial hardship for unvaccinated people, and the creation of a class of citizens who are not allowed to fully participate in many areas of society.
Competing Interest Statement
The authors have declared no competing interest.
This study received no grant from any funding agency, commercial, or not-for-profit sectors. It has also received no support of any kind from any individual or organization. BH is supported by a personal research grant from the University of Wroclaw within the ‘Excellence Initiative, Research University’ framework and by a scholarship from the Polish Ministry of Education and Science. None of these institutions were involved in this research and did not fund it directly.
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv