Durability analysis of the highly effective BNT162b2 vaccine against COVID-19
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Abstract
COVID-19 vaccines are effective, but breakthrough infections have been increasingly reported. We conducted a test-negative case-control study to assess the durability of protection after full vaccination with BNT162b2 against polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection, in a national medical practice from January 2021 through January 2022. We fit conditional logistic regression (CLR) models stratified on residential county and calendar time of testing to assess the association between time elapsed since vaccination and the odds of symptomatic infection or non-COVID-19 hospitalization (negative control), adjusted for several covariates. There were 5,985 symptomatic individuals with a positive test after full vaccination with BNT162b2 (cases) and 32,728 negative tests contributed by 27,753 symptomatic individuals after full vaccination (controls). The adjusted odds of symptomatic infection were higher 250 days after full vaccination versus at the date of full vaccination (Odds Ratio [OR]: 3.62, 95% CI: 2.52 to 5.20). The odds of infection were still lower 285 days after the first BNT162b2 dose as compared to 4 days after the first dose (OR: 0.50, 95% CI: 0.37 to 0.67), when immune protection approximates the unvaccinated status. Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. The odds of non-COVID-19 associated hospitalization (negative control) decreased with time since vaccination, suggesting a possible underestimation of waning protection by this approach due to confounding factors. In summary, BNT162b2 strongly protected against symptomatic SARS-CoV-2 infection for at least 8 months after full vaccination, but the degree of protection waned significantly over this period.
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SciScore for 10.1101/2021.09.04.21263115: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: 22 This study was reviewed and deemed exempt by the Mayo Clinic institutional review board. Sex as a biological variable not detected. Randomization If an individual contributed multiple negative symptomatic tests within 15 days of each other, then one of those tests was randomly selected as a control while the others were dropped; this step was taken to avoid counting multiple controls from a potential single symptomatic illness. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Specifically, the additional variables considered here were: Covariates: The CLR model was then defined by the equation, , where the covariates and … SciScore for 10.1101/2021.09.04.21263115: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: 22 This study was reviewed and deemed exempt by the Mayo Clinic institutional review board. Sex as a biological variable not detected. Randomization If an individual contributed multiple negative symptomatic tests within 15 days of each other, then one of those tests was randomly selected as a control while the others were dropped; this step was taken to avoid counting multiple controls from a potential single symptomatic illness. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Specifically, the additional variables considered here were: Covariates: The CLR model was then defined by the equation, , where the covariates and conditioning variables X1-X7 are the same as described above for the primary analysis. Covariatessuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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