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Multicenter Study
. 2024 Feb 6;331(5):408-416.
doi: 10.1001/jama.2023.27022.

Effectiveness of Bivalent mRNA COVID-19 Vaccines in Preventing SARS-CoV-2 Infection in Children and Adolescents Aged 5 to 17 Years

Leora R Feldstein  1 , Amadea Britton  1 , Lauren Grant  1 , Ryan Wiegand  1 , Jasmine Ruffin  1 , Tara M Babu  2 , Melissa Briggs Hagen  1 , Jefferey L Burgess  3 , Alberto J Caban-Martinez  4 , Helen Y Chu  2 , Katherine D Ellingson  3 , Janet A Englund  5 , Kurt T Hegmann  6 , Zuha Jeddy  7 , Adam S Lauring  8 , Karen Lutrick  3 , Emily T Martin  9 , Clare Mathenge  10 , Jennifer Meece  11 , Claire M Midgley  1 , Arnold S Monto  9 , Gabriella Newes-Adeyi  7 , Leah Odame-Bamfo  10 , Lauren E W Olsho  7 , Andrew L Phillips  6 , Ramona P Rai  7 , Sharon Saydah  1 , Ning Smith  12 , Laura Steinhardt  1 , Harmony Tyner  13 , Meredith Vandermeer  12 , Molly Vaughan  7 , Sarang K Yoon  6 , Manjusha Gaglani  10 , Allison L Naleway  12
Affiliations
Multicenter Study

Effectiveness of Bivalent mRNA COVID-19 Vaccines in Preventing SARS-CoV-2 Infection in Children and Adolescents Aged 5 to 17 Years

Leora R Feldstein et al. JAMA. .

Abstract

Importance: Bivalent mRNA COVID-19 vaccines were recommended in the US for children and adolescents aged 12 years or older on September 1, 2022, and for children aged 5 to 11 years on October 12, 2022; however, data demonstrating the effectiveness of bivalent COVID-19 vaccines are limited.

Objective: To assess the effectiveness of bivalent COVID-19 vaccines against SARS-CoV-2 infection and symptomatic COVID-19 among children and adolescents.

Design, setting, and participants: Data for the period September 4, 2022, to January 31, 2023, were combined from 3 prospective US cohort studies (6 sites total) and used to estimate COVID-19 vaccine effectiveness among children and adolescents aged 5 to 17 years. A total of 2959 participants completed periodic surveys (demographics, household characteristics, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (irrespective of symptoms); participants submitted additional nasal swabs at the onset of any symptoms.

Exposure: Vaccination status was captured from the periodic surveys and supplemented with data from state immunization information systems and electronic medical records.

Main outcome and measures: Respiratory swabs were tested for the presence of the SARS-CoV-2 virus using reverse transcriptase-polymerase chain reaction. SARS-CoV-2 infection was defined as a positive test regardless of symptoms. Symptomatic COVID-19 was defined as a positive test and 2 or more COVID-19 symptoms within 7 days of specimen collection. Cox proportional hazards models were used to estimate hazard ratios for SARS-CoV-2 infection and symptomatic COVID-19 among participants who received a bivalent COVID-19 vaccine dose vs participants who received no vaccine or monovalent vaccine doses only. Models were adjusted for age, sex, race, ethnicity, underlying health conditions, prior SARS-CoV-2 infection status, geographic site, proportion of circulating variants by site, and local virus prevalence.

Results: Of the 2959 participants (47.8% were female; median age, 10.6 years [IQR, 8.0-13.2 years]; 64.6% were non-Hispanic White) included in this analysis, 25.4% received a bivalent COVID-19 vaccine dose. During the study period, 426 participants (14.4%) had laboratory-confirmed SARS-CoV-2 infection. Among these 426 participants, 184 (43.2%) had symptomatic COVID-19, 383 (89.9%) were not vaccinated or had received only monovalent COVID-19 vaccine doses (1.38 SARS-CoV-2 infections per 1000 person-days), and 43 (10.1%) had received a bivalent COVID-19 vaccine dose (0.84 SARS-CoV-2 infections per 1000 person-days). Bivalent vaccine effectiveness against SARS-CoV-2 infection was 54.0% (95% CI, 36.6%-69.1%) and vaccine effectiveness against symptomatic COVID-19 was 49.4% (95% CI, 22.2%-70.7%). The median observation time after vaccination was 276 days (IQR, 142-350 days) for participants who received only monovalent COVID-19 vaccine doses vs 50 days (IQR, 27-74 days) for those who received a bivalent COVID-19 vaccine dose.

Conclusion and relevance: The bivalent COVID-19 vaccines protected children and adolescents against SARS-CoV-2 infection and symptomatic COVID-19. These data demonstrate the benefit of COVID-19 vaccine in children and adolescents. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Caban-Martinez reported receiving grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Dr Chu reported receiving personal fees from AbbVie, Vindico, Ellume, Medscape, Merck, Clinical Care Options, Cataylst Medical Education, Vir, Pfizer, and Prime Education. Dr Englund reported receiving personal fees from AbbVie, AstraZeneca, Merck, Meissa Vaccines, Moderna, Sanofi Pasteur, Pfizer, Ark Biopharma, GSK (formerly GlaxoSmithKline), and Shinogi. Dr Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Ms Jeddy reported being an employee of Abt Associates. Dr Lauring reported receiving personal fees from Roche and Sanofi and receiving grants from the Flu Lab and the Burroughs Wellcome Fund. Dr Martin reported receiving grants from Merck. Dr Monto reported receiving personal fees from Roche. Dr Newes-Adeyi reported being an employee of Abt Associates. Dr Olsho reported being an employee of Abt Associates and a study participant in CASCADIA. Dr Phillips reported receiving personal fees from Novavax. Ms Rai reported being an employee of Abt Associates. Dr Vaughan reported being an employee of Abt Associates. Dr Yoon reported receiving personal fees from Novavax. Dr Gaglani reported serving as co-chair of the infectious diseases and immunization committee and the respiratory syncytial virus taskforce lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

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