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. 2022 May 19;386(20):1899-1909.
doi: 10.1056/NEJMoa2202826. Epub 2022 Mar 30.

BNT162b2 Protection against the Omicron Variant in Children and Adolescents

Collaborators, Affiliations

BNT162b2 Protection against the Omicron Variant in Children and Adolescents

Ashley M Price et al. N Engl J Med. .

Abstract

Background: Spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 (omicron) variant, which led to increased U.S. hospitalizations for coronavirus disease 2019 (Covid-19), generated concern about immune evasion and the duration of protection from vaccines in children and adolescents.

Methods: Using a case-control, test-negative design, we assessed vaccine effectiveness against laboratory-confirmed Covid-19 leading to hospitalization and against critical Covid-19 (i.e., leading to receipt of life support or to death). From July 1, 2021, to February 17, 2022, we enrolled case patients with Covid-19 and controls without Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2 messenger RNA vaccine) at least 14 days before illness among case patients and controls, according to time since vaccination for patients 12 to 18 years of age and in periods coinciding with circulation of B.1.617.2 (delta) (July 1, 2021, to December 18, 2021) and omicron (December 19, 2021, to February 17, 2022) among patients 5 to 11 and 12 to 18 years of age.

Results: We enrolled 1185 case patients (1043 [88%] of whom were unvaccinated, 291 [25%] of whom received life support, and 14 of whom died) and 1627 controls. During the delta-predominant period, vaccine effectiveness against hospitalization for Covid-19 among adolescents 12 to 18 years of age was 93% (95% confidence interval [CI], 89 to 95) 2 to 22 weeks after vaccination and was 92% (95% CI, 80 to 97) at 23 to 44 weeks. Among adolescents 12 to 18 years of age (median interval since vaccination, 162 days) during the omicron-predominant period, vaccine effectiveness was 40% (95% CI, 9 to 60) against hospitalization for Covid-19, 79% (95% CI, 51 to 91) against critical Covid-19, and 20% (95% CI, -25 to 49) against noncritical Covid-19. During the omicron period, vaccine effectiveness against hospitalization among children 5 to 11 years of age was 68% (95% CI, 42 to 82; median interval since vaccination, 34 days).

Conclusions: BNT162b2 vaccination reduced the risk of omicron-associated hospitalization by two thirds among children 5 to 11 years of age. Although two doses provided lower protection against omicron-associated hospitalization than against delta-associated hospitalization among adolescents 12 to 18 years of age, vaccination prevented critical illness caused by either variant. (Funded by the Centers for Disease Control and Prevention.).

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Figures

Figure 1
Figure 1. Study Enrollment and Outcomes (July 1, 2021–February 17, 2022).
Covid-19 denotes coronavirus disease 2019.
Figure 2
Figure 2. Effectiveness of the BNT162b2 Vaccine against Hospitalization for Covid-19, Stratified According to Age and Variant.
The delta-predominant period was defined as July 1, 2021, through December 18, 2021. The omicron-predominant period was defined as December 19, 2021, to February 17, 2022. For children 5 to 11 years of age, evaluation was limited to the omicron period because of the recent introduction of vaccination in this group (on October 29, 2021). For the subgroup analysis of time since vaccination, 4 case patients were not included because of missing dates of vaccination. Vaccine effectiveness was calculated as (1−adjusted odds ratio)×100, where the odds ratio is the odds of vaccination in case patients as compared with controls.
Figure 3
Figure 3. Effectiveness of the BNT162b2 Vaccine against Hospitalization for Critical as Compared with Noncritical Covid-19 in Adolescents 12 to 18 Years of Age, Stratified According to Variant.
Numbers were insufficient to stratify the analysis according to disease severity among children 5 to 11 years of age. In this analysis, only subgroups of case patients were based on disease severity; the entire control group (regardless of disease severity) served as the basis for comparison. Critical Covid-19 was defined as Covid-19 leading to life support (i.e., noninvasive mechanical ventilation [bilevel positive airway pressure or continuous positive airway pressure] or invasive mechanical ventilation, vasoactive infusions, or extracorporeal membrane oxygenation) or death. Information on this outcome was missing for 8 case patients admitted during the omicron period. Vaccine effectiveness was calculated as (1−adjusted odds ratio)×100, where the odds ratio is the odds of vaccination in case patients as compared with controls.

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References

    1. Food and Drug Administration. FDA approves first COVID-19 vaccine. August 23, 2021. (https://www.fda.gov/news-events/press-announcements/fda-approves-first-c...).
    1. Food and Drug Administration. FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. October 29, 2021. (https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfize...).
    1. Glatman-Freedman A, Hershkovitz Y, Kaufman Z, Dichtiar R, Keinan-Boker L, Bromberg M. Effectiveness of BNT162b2 vaccine in adolescents during outbreak of SARS-CoV-2 delta variant infection, Israel, 2021. Emerg Infect Dis 2021;27:2919-2922. - PMC - PubMed
    1. Olson SM, Newhams MM, Halasa NB, et al. Effectiveness of BNT162b2 vaccine against critical Covid-19 in adolescents. N Engl J Med 2022;386:713-723. - PMC - PubMed
    1. Olson SM, Newhams MM, Halasa NB, et al. Effectiveness of Pfizer-BioNTech mRNA vaccination against COVID-19 hospitalization among persons aged 12–18 years — United States, June–September 2021. MMWR Morb Mortal Wkly Rep 2021;70:1483-1488. - PMC - PubMed

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