Vaccine effectiveness of the BNT162b2 mRNA COVID-19 vaccine against RT-PCR confirmed SARS-CoV-2 infections, hospitalisations and mortality in prioritised risk groups

  1. Hanne-Dorthe Emborg
  2. Palle Valentiner-Branth
  3. Astrid Blicher Schelde
  4. Katrine Finderup Nielsen
  5. Mie Agermose Gram
  6. Ida Rask Moustsen-Helms
  7. Manon Chaine
  8. Ulla Holten Seidelin
  9. Jens Nielsen

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Abstract

Objective

To estimate in a real life setting, the vaccine effectiveness of the BNT162b2 mRNA vaccine against confirmed SARS-CoV-2 infection, hospital admission, and death among five priority groups for vaccination

Design

Cohort study

Setting

Roll-out of the BNT162b2 mRNA vaccine in Denmark

Participants

864,096 individuals who were first inline to receive the BNT162b2 mRNA vaccine: 46,101 long-term care facility (LTCF) residents, 61,805 individuals 65 years and older living at home but requiring practical help and personal care (65PHC), 98,533 individuals ≥85 years of age (+85), 425,799 health-care workers (HCWs), and 231,858 individuals with comorbidities that predispose for severe COVID-19 disease (SCD).

Intervention

vaccination with BNT162b2 mRNA vaccine

Main outcome measures

RT-PCR confirmed SARS-CoV-2 infections, COVID-19 related admissions within 14 days after a confirmed SARS-CoV-2 infection, all-cause admission, COVID-19 related death within 30 days after confirmed SARS-CoV-2 infection, and all-cause death.

Results

Beyond 7 days after the second dose, the VE against SARS-CoV-2 infection in all groups ranged from 53-86%. In 65PHC, HCW and SCD, we observed a substantial reduction in risk of infection 0-7 days after the second dose ranging from 46-71%. The VE against COVID-19 related admissions ranged from 75-87% in all groups except +85 and HCWs where no events occurred. For COVID-19 related deaths, a significant VE was observed in LTCF residents (VE of 89%) and 65PHC (VE of 97%), whereas no events were observed in the three remaining groups. VE against all-cause death ranged from 26-73% in all groups except HCW where an insignificant VE was estimated. For all-cause admission, the VE ranged from 37-50% in all groups except in SCD where a negative VE was observed.

Conclusion

In a real-life setting and more than 7 days after the second dose of BNT162b2 mRNA was administered to the most vulnerable individuals, the vaccine was associated with a reduction of SARS-CoV-2 infection (53-86%) and COVID-19 related admissions (≥75%) or deaths (≥89%).

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  1. ScreenIT

    SciScore for 10.1101/2021.05.27.21257583: (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:
    Limitations: End of December 2020 beginning of January 2021, the SARS-CoV-2 incidence in the population was very high and COVID-19 outbreaks were observed at several LTCF [2]. As a result, most of the COVID-19 events were observed during the start of the study, where a large proportion of the priority groups were unvaccinated. Therefore, it was important to account for calendar time in the estimation of the VE’s. In all priority groups, the second dose was administered at a median of 22-25 days after first dose, which did not allow sufficient time to observe the full effect of the first dose. With a high vaccine coverage as observed among LTCF and 85+, the unvaccinated group that is used for comparison becomes very small and include a selected population different from the majority. This implies that VE estimates in this setting should be interpreted with caution. In conclusion, across all five priority groups, the overall VE against COVID-19 infection >7 days after the second dose was 82%. It is encouraging that among the most vulnerable citizens and those with the highest risk of infection, we observed a high reduction in risk of infection when fully vaccinated with BNT162b2 mRNA. In addition, though COVID-19 related death in many priority groups are rare events following vaccination, over all COVID-19 related admissions and deaths were reduced by 93% and 94%, respectively.

    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

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.05.27.21257583v1 on medRxiv