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. 2022 Jun 14;327(22):2210-2219.
doi: 10.1001/jama.2022.7493.

Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance

Katherine E Fleming-Dutra  1 , Amadea Britton  1   2 , Nong Shang  1 , Gordana Derado  1 , Ruth Link-Gelles  1 , Emma K Accorsi  1   2 , Zachary R Smith  1 , Joseph Miller  1 , Jennifer R Verani  1 , Stephanie J Schrag  1
Affiliations

Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance

Katherine E Fleming-Dutra et al. JAMA. .

Abstract

Importance: Efficacy of 2 doses of the BNT162b2 COVID-19 vaccine (Pfizer-BioNTech) against COVID-19 was high in pediatric trials conducted before the SARS-CoV-2 Omicron variant emerged. Among adults, estimated vaccine effectiveness (VE) of 2 BNT162b2 doses against symptomatic Omicron infection was reduced compared with prior variants, waned rapidly, and increased with a booster.

Objective: To evaluate the association of symptomatic infection with prior vaccination with BNT162b2 to estimate VE among children and adolescents during Omicron variant predominance.

Design, setting, and participants: A test-negative, case-control analysis was conducted using data from 6897 pharmacy-based, drive-through SARS-CoV-2 testing sites across the US from a single pharmacy chain in the Increasing Community Access to Testing platform. This analysis included 74 208 tests from children 5 to 11 years of age and 47 744 tests from adolescents 12 to 15 years of age with COVID-19-like illness who underwent SARS-CoV-2 nucleic acid amplification testing from December 26, 2021, to February 21, 2022.

Exposures: Two BNT162b2 doses 2 weeks or more before SARS-CoV-2 testing vs no vaccination for children; 2 or 3 doses 2 weeks or more before testing vs no vaccination for adolescents (who are recommended to receive a booster dose).

Main outcomes and measures: Symptomatic infection. The adjusted odds ratio (OR) for the association of prior vaccination and symptomatic SARS-CoV-2 infection was used to estimate VE: VE = (1 - OR) × 100%.

Results: A total of 30 999 test-positive cases and 43 209 test-negative controls were included from children 5 to 11 years of age, as well as 22 273 test-positive cases and 25 471 test-negative controls from adolescents 12 to 15 years of age. The median age among those with included tests was 10 years (IQR, 7-13); 61 189 (50.2%) were female, 75 758 (70.1%) were White, and 29 034 (25.7%) were Hispanic/Latino. At 2 to 4 weeks after dose 2, among children, the adjusted OR was 0.40 (95% CI, 0.35-0.45; estimated VE, 60.1% [95% CI, 54.7%-64.8%]) and among adolescents, the OR was 0.40 (95% CI, 0.29-0.56; estimated VE, 59.5% [95% CI, 44.3%-70.6%]). During month 2 after dose 2, among children, the OR was 0.71 (95% CI, 0.67-0.76; estimated VE, 28.9% [95% CI, 24.5%-33.1%]) and among adolescents, the OR was 0.83 (95% CI, 0.76-0.92; estimated VE, 16.6% [95% CI, 8.1%-24.3%]). Among adolescents, the booster dose OR 2 to 6.5 weeks after the dose was 0.29 (95% CI, 0.24-0.35; estimated VE, 71.1% [95% CI, 65.5%-75.7%]).

Conclusions and relevance: Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly. Among adolescents, the estimated effectiveness increased after a booster dose.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Inclusion Criteria for Analysis of Association of BNT162b2 With Symptomatic SARS-CoV-2 Infection in Children and Adolescents
Data from the Increasing Community Access to Testing (ICATT) platform were used from children and adolescents tested from December 26, 2021, to February 21, 2022, ie, during predominance of the SARS-CoV-2 Omicron variant. During the analysis period, ICATT contracted 4 pharmacy chains, which used different versions of the registration questionnaire and not all captured data on booster doses. This analysis was limited to a single chain that collected data on booster doses and provided 82% of tests platform-wide for children and adolescents aged 5 to 15 years during the analysis period. Nasal swabs were self-collected at drive-through sites and tested for SARS-CoV-2 either onsite with the ID Now (Abbott Diagnostics Scarborough Inc) rapid nucleic acid amplification test (NAAT) or at contracted laboratories using laboratory-based NAAT (TaqPath COVID-19 Combo Kit [Thermo Fischer Scientific Inc] or COVID-19 RT-PCR Test [Laboratory Corporation of America]). aFor example, reported vaccine receipt but no doses or reported no vaccine receipt but reported doses.
Figure 2.
Figure 2.. BNT162b2 2-Dose Adjusted Estimated Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection In Children and Adolescents
The graph shows BNT162b2 2-dose adjusted estimated vaccine effectiveness (VE = [1 − odds ratio] × 100%) with 95% CI against symptomatic SARS-CoV-2 infection for children aged 5 to 11 years (shown in blue) and adolescents aged 12 to 15 years (shown in orange), from December 26, 2021, to February 21, 2022. Adolescents who received booster doses are not included in this figure. Estimated VE (2 doses vs no vaccination) with 95% CI by month since second dose was adjusted for calendar day of test (continuous variable), race, ethnicity, sex, testing site region, and testing site census tract Social Vulnerability Index (SVI; continuous variable). Tests with missing sex (n = 30 for 5-11 years, n = 122 for 12-15 years) and missing SVI (n = 52 for 5-11 years, n = 24 for 12-15 years) were not included in adjusted analyses. Unknown race (n = 8278 for 5-11 years, n = 5675 for 12-15 years) and ethnicity (n = 5435 for 5-11 years, n = 3578 for 12-15 years) were coded as categorical levels within each variable to retain those tests in regression models. Sample size for estimates for each age group and month are shown in the table at the bottom of the figure. A likelihood ratio test comparing models with and without an interaction term between age group (5-11 and 12-15 years) and month (0, 1, 2) was used to evaluate the difference between the waning patterns (P value for month 0: .99; month 1: .40; month 2: .01, and for months 0-2 combined: .06). Among children aged 5 to 11 years who did not receive the vaccine, 25 241 tested positive and 33 128 tested negative for SARS-CoV-2; among adolescents aged 12 to 15 years who did not receive the vaccine, 11 436 tested positive and 13 278 tested negative for SARS-CoV-2. aVaccination dose dates were collected as month and year. Month since second dose was calculated as the difference between the month and year of testing and the month and year of the second vaccine dose (at least 2 weeks after the second dose). The range of possible days after second dose assumes 30 days per month. The maximum difference between calendar month of SARS-CoV-2 test and calendar month of the second dose was 3 months for children aged 5 to 11 years (tested during February 2022 and second dose received in November 2021) and 9 months for adolescents aged 12 to 15 years (tested during February 2022 and second dose received in May 2021). Estimated VE for children 5 to 11 years of age during month 3 was not calculated (vaccinated children during month 3 since second dose: n = 852) or for adolescents 12 to 15 years of age during month 9 (vaccinated adolescents during month 9 since second dose: n = 36) because the number of possible days since the second dose was limited in the last month. This was a result of timing of vaccine authorization (children became eligible for second doses in late November 2021 and adolescents in late May 2021) and by the end of the study period (test dates were only included through February 21, 2022).
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Comment in

  • Protecting Children Against Omicron.
    Katz SE, Edwards K. Katz SE, et al. JAMA. 2022 Jun 14;327(22):2195-2197. doi: 10.1001/jama.2022.7315. JAMA. 2022. PMID: 35560309 No abstract available.

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