Effectiveness of the BNT162b2 vaccine among children 5-11 and 12-17 years in New York after the Emergence of the Omicron Variant

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Abstract

Importance

There is limited evidence on the effectiveness of the BNT162b2 vaccine for children, particularly those 5-11 years and after the Omicron variant’s emergence.

Objective

To estimate BNT162b2 vaccine effectiveness against COVID cases and hospitalizations among children 5-11 years and 12-17 years during December, 2021 and January, 2022.

Design

Analyses of cohorts constructed from linked statewide immunization, laboratory testing, and hospitalization databases.

Setting/Participants

New York State children 5-17 years.

Main outcomes/measures

New laboratory-confirmed COVID-19 cases and hospitalizations. Comparisons were made using the incidence rate ratio (IRR), comparing outcomes by vaccination status, and estimated vaccine effectiveness (VE: 1-[1/IRR]).

Results

From December 13, 2021 to January 30, 2022, among 852,384 fully-vaccinated children 12-17 years and 365,502 children 5-11 years, VE against cases declined from 66% (95% CI: 64%, 67%) to 51% (95% CI: 48%, 54%) for those 12-17 years and from 68% (95% CI: 63%, 72%) to 12% (95% CI: 6%, 16%) for those 5-11 years. During the January 24-30 week, VE for children 11 years was 11% (95%CI -3%, 23%) and for those age 12 was 67% (95% CI: 62%, 71%). VE against hospitalization declined changed from 85% (95% CI: 63%, 95%) to 73% (95% CI: 53%, 87%) for children 12-17 years, and from 100% (95% CI: -189%, 100%) to 48% (95% CI: -12%, 75%) for those 5-11 years. Among children newly fully-vaccinated December 13, 2021 to January 2, 2022, VE against cases within two weeks of full vaccination for children 12-17 years was 76% (95% CI: 71%, 81%) and by 28-34 days it was 56% (95% CI: 43%, 63%). For children 5-11, VE against cases declined from 65% (95% CI: 62%, 68%) to 12% (95% CI: 8%, 16%) by 28-34 days.

Conclusions and Relevance

In the Omicron era, the effectiveness against cases of BNT162b2 declined rapidly for children, particularly those 5-11 years. However, vaccination of children 5-11 years was protective against severe disease and is recommended. These results highlight the potential need to study alternative vaccine dosing for children and the continued importance layered protections, including mask wearing, to prevent infection and transmission.

Article activity feed

  1. SciScore for 10.1101/2022.02.25.22271454: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The New York State Department of Health Institutional Review Board (IRB) determined this is a surveillance activity necessary for public health work, and therefore waived the need for IRB review.
    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:
    The findings in this study are subject to limitations. First, home testing, whichis not reported and increased during the analysis period, would impact conclusions if testing practices differed by vaccine status. This potential bias would not impact hospitalizations. During this highest-incidence period, including for severe disease, for children, there were still relatively few children admissions. Additional data are needed to fully-understand VE trends against severe disease.2,9 By the end of January, 12.5% of vaccinated children 12-17 years had received a booster, likely adding protection to that group, although the time-since-vaccination analysis had no boosted children. This analysis compared early vaccinators in the younger age group withlater vaccinators in the older age group, who may differ in test-seeking or exposures. Similar conclusions regarding relative VE declines between children 5-11 and 12-17 years using open cohorts suggests this trend is robust. Our data support vaccine protection against severe disease among children 5-11 years, but suggest rapid loss of protection against infection, in the Omicron variant era. Should such findings be replicated in other settings, review of the dosing schedule for children 5-11 years appears prudent. At this time, efforts to increase primary vaccination coverage in this age group, which remains <25% nationally, should continue. Given rapid loss of protection against infections, these results highlight the continued impor...

    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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