Abstract
Vaccines are vital to control the Coronavirus disease 2019 (COVID-19) pandemic, but the pressure to quickly move from research to implementation in the context of a pandemic crisis raises concerns about benefits and harms, vaccine acceptance and fair access. Here we present a strategy for the COVID-19 vaccination rollout which can be rapidly embedded and would offer direct real-world evidence of vaccines on a large scale to generate otherwise unobtainable knowledge on the safety and perhaps efficacy of COVID-19 vaccines. Such strategic rollouts leveraging randomization can provide important evidence, for COVID-19 and in future occasions, for vaccines and beyond.
Highlights
Vaccines are vital to control the Coronavirus disease 2019 (COVID-19) pandemic, but the pressure to quickly move from research to implementation in the context of a pandemic crisis raises concerns about benefits and harms, vaccine acceptance and fair access
The randomized clinical trials (RCTs) supporting approval of the first two vaccines include roughly 30,000– 40,000 participants, provide safety data gathered over a period of at least 8 weeks, but have too few clinical events to assess outcomes like mortality, hospitalizations, and seri
Even if such randomized rollout was limited to only a single small jurisdiction or integrated healthcare organization allowing to collect the outcomes [11], the data on vaccines would likely be many-fold larger than all clinical evidence available at approval
Summary
Vaccines are vital to control the Coronavirus disease 2019 (COVID-19) pandemic, but the pressure to quickly move from research to implementation in the context of a pandemic crisis raises concerns about benefits and harms, vaccine acceptance and fair access. All authors attest they meet the ICMJE criteria for authorship and that no others meeting the criteria have been omitted. In 2008, Medicaid expansion in Oregon was implemented by using random drawing from a waiting list to provide uninsured low-income adults the chance to apply for Medicaid. Designed as experiment, this process ensured fairness, it provided a unique opportunity for generating high-quality evidence: studies showed, for example, that Medicaid coverage did not significantly improve physical health in the short-term but increased healthcare utilization, changed condition-specific treatments and reduced depression incidence [6].
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