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Reviews of "FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system"

Reviewers: Aaloke Mody (Washington University) | 📒📒📒 ◻️◻️ • Tiancheng Zhao (University of Illinois at Urbana-Champaign) | 📒📒📒◻️◻️

Published onApr 26, 2021
Reviews of "FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system"
key-enterThis Pub is a Review of
FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system
Description

AbstractLarge Phase 3 clinical trials of the two FDA-authorized COVID-19 vaccines, mRNA-1273 (Moderna) and BNT162b2 (Pfizer/BioNTech), have demonstrated efficacies of 94.1% (n = 30,420, 95% CI: 89.3-96.8) and 95% (n = 43,448, 95% CI: 90.3-97.6) in preventing symptomatic COVID-19, respectively. Given the ongoing vaccine rollout to healthcare personnel and residents of long-term care facilities, here we provide a preliminary assessment of real-world vaccination efficacy in 62,138 individuals from the Mayo Clinic and associated health system (Arizona, Florida, Minnesota, Wisconsin) between December 1st 2020 and February 8th 2021. Our retrospective analysis contrasts 31,069 individuals receiving at least one dose of either vaccine with 31,069 unvaccinated individuals who are propensity-matched based on demographics, location (zip code), and number of prior SARS-CoV-2 PCR tests. 8,041 individuals received two doses of a COVID-19 vaccine and were at risk for infection at least 36 days after their first dose. Administration of two COVID-19 vaccine doses was 88.7% effective in preventing SARS-CoV-2 infection (95% CI: 68.4-97.1%) with onset at least 36 days after the first dose. Furthermore, vaccinated patients who were subsequently diagnosed with COVID-19 had significantly lower 14-day hospital admission rates than propensity-matched unvaccinated COVID-19 patients (3.7% vs. 9.2%; Relative Risk: 0.4; p-value: 0.007). Building upon the previous randomized trials of these vaccines, this study demonstrates their real-world effectiveness in reducing the rates of SARS-CoV-2 infection and COVID-19 severity among individuals at highest risk for infection.

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Summary of Reviews: This preprint found that two vaccine doses provide 88.7% effectiveness at preventing infection and lowered hospitalizations. The reviewers found the preprint potentially informative, due to the propensity score matching method, and could be improved by additional studies.

Reviewer 1 (Aaloke Mody) | 📒📒📒 ◻️◻️

Reviewer 2 (Tiancheng Zhao) | 📒📒📒 ◻️◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

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