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131 Studies Sort Effectiveness of

BNT162b2 Vaccine
Against Omicron in
Children 5 to 11 Years
of Age
UPDATED 11 AUGUST 2022

Lead Author: Tan, Sharon. Citation: N Engl J

Med. 2022 Aug 11; 387:525–532. 
DOI 10.1056/NEJMoa2203209
Sponsor(s): Not Reported

Objectives, Design Primary Endpoints and

and Size Definitions

Dataset
Dose 1
Dose 2

Adjusted
Vaccine
Effectiveness
Against COVID-
19-related
Hospitalization
in Children 5 to Filters
11 Years of Age, Vaccine(s)
by Time Since
Receipt of
Vaccine Variant(s)

Age (years)

Dose
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Dose

Time after Dose 1

≥ 1 Day
1–6 Days
42.3 (24.9 to 55.7)
34.5 (-18.5 to 63.8) Time Period
Emergency uses of the Pfizer-BioNTech
7–14 Days 15.7 (-26.5 to 43.8)
15–29 Days 44.2 (18.9 to 61.6)
≥ 30 Days 51.6 (7.1 to 74.8)

Time after Dose 2

COVID-19 Vaccine have not been approved

1–6 Days 64.7 (37.3 to 80.2)
≥ 7 Days 82.7 (74.8 to 88.2)
7–14 Days 87.8 (72.2 to 94.7)
15–29 Days 84.5 (72.7 to 91.2)
30–59 Days 80.4 (67.0 to 88.4)
≥ 60 Days NA

or licensed by FDA, but have been authorized 0.0 20.0 40.0 60.0 80.0

Adjusted Vaccine Effectiveness, % (95% CI)

[Reference: Unvaccinated]
100.0

by FDA, under an Emergency Use

Authorization (EUA) to prevent Coronavirus
Disease 2019 (COVID-19) in individuals 6
months of age and older. The emergency
Prescribing Information and Fact Sheets
uses are only authorized for the duration of
the declaration that circumstances exist
justifying the authorization of emergency
use of the medical product under Section
564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization
revoked sooner.

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