Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine

  1. Tal Patalon
  2. Yaki Saciuk
  3. Asaf Peretz
  4. Galit Perez
  5. Yoav Lurie
  6. Yasmin Maor
  7. Sivan Gazit

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Abstract

The duration of protection of the third (booster) dose of the BioNTech/Pfizer BNT162b2 mRNA Coronavirus Disease 2019 vaccine has been the subject of recent investigations, as global discussions around the necessity and effectiveness of a fourth dose are already underway. By conducting a retrospective study implementing a test-negative case-control design, analyzing 546,924 PCR tests performed throughout January 2022 by 389,265 persons who received at least two doses, we find that the effectiveness in each month-since-vaccination decreases significantly. Compared to those vaccinated five months prior to the outcome period, on August 2021, relative protection against infection waned from 53.4% a month after vaccination to 16.5% three months after vaccination. These results suggest that there is a significant waning of vaccine effectiveness against the Omicron variant of the third dose of the BNT162b2 vaccine within a few months after administration. Additional information could assist to comprehensively estimate the effectiveness of the three-dose-strategy.

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  1. Version published to 10.1038/s41467-022-30884-6
  2. ScreenIT

    SciScore for 10.1101/2022.02.25.22271494: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results 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: We detected the following sentences addressing limitations in the study:
    This study has some important limitations. The main limitation of every observational SARS-CoV-2 study is a potential bias stemming from healthcare related behavior as it pertains to PCR testing. This issue has been discussed in previous studies as well,7,11,19 and was more of a concern during the past months, in light of changing testing policies in Israel during the Omicron surge, where an overwhelming numbers of infected individuals did not allow the same test-for-all policy, implemented in previous waves. The test-negative design, which does not assume that a lack of a positive test equals a negative test and somewhat adjusts for testing volume, attempts to better mitigate this bias and is the reason we chose this method for this analysis., especially Additionally, the August 2021 vaccinees, who served as the comparison group in the main analysis were generally older and correspondingly sicker. This limitation has also been discussed in previous COVID research, as vaccination rollout generally prioritized chronically ill individuals. Nonetheless, our matching and adjustment approach renders residual confounding by indication less likely. Lastly, as the Omicron variant was the dominant variant in Israel during the analysis, the waning effect against other strains could not be evaluated. This could explain that in our secondary analysis of the marginal effectiveness, the additional benefit gained one month after inoculation was lower than the VE demonstrated in the same tim...

    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.

    About SciScore

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  3. Version published to 10.1101/2022.02.25.22271494 on medRxiv