tetano
Editor, Senior Moderator
JAMA
. 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[SUP] 1 [/SUP], Amadea Britton[SUP] 1 [/SUP], Lauren Grant[SUP] 1 [/SUP], Ryan Wiegand[SUP] 1 [/SUP], Jasmine Ruffin[SUP] 1 [/SUP], Tara M Babu[SUP] 2 [/SUP], Melissa Briggs Hagen[SUP] 1 [/SUP], Jefferey L Burgess[SUP] 3 [/SUP], Alberto J Caban-Martinez[SUP] 4 [/SUP], Helen Y Chu[SUP] 2 [/SUP], Katherine D Ellingson[SUP] 3 [/SUP], Janet A Englund[SUP] 5 [/SUP], Kurt T Hegmann[SUP] 6 [/SUP], Zuha Jeddy[SUP] 7 [/SUP], Adam S Lauring[SUP] 8 [/SUP], Karen Lutrick[SUP] 3 [/SUP], Emily T Martin[SUP] 9 [/SUP], Clare Mathenge[SUP] 10 [/SUP], Jennifer Meece[SUP] 11 [/SUP], Claire M Midgley[SUP] 1 [/SUP], Arnold S Monto[SUP] 9 [/SUP], Gabriella Newes-Adeyi[SUP] 7 [/SUP], Leah Odame-Bamfo[SUP] 10 [/SUP], Lauren E W Olsho[SUP] 7 [/SUP], Andrew L Phillips[SUP] 6 [/SUP], Ramona P Rai[SUP] 7 [/SUP], Sharon Saydah[SUP] 1 [/SUP], Ning Smith[SUP] 12 [/SUP], Laura Steinhardt[SUP] 1 [/SUP], Harmony Tyner[SUP] 13 [/SUP], Meredith Vandermeer[SUP] 12 [/SUP], Molly Vaughan[SUP] 7 [/SUP], Sarang K Yoon[SUP] 6 [/SUP], Manjusha Gaglani[SUP] 10 [/SUP], Allison L Naleway[SUP] 12 [/SUP]
Affiliations
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.
. 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[SUP] 1 [/SUP], Amadea Britton[SUP] 1 [/SUP], Lauren Grant[SUP] 1 [/SUP], Ryan Wiegand[SUP] 1 [/SUP], Jasmine Ruffin[SUP] 1 [/SUP], Tara M Babu[SUP] 2 [/SUP], Melissa Briggs Hagen[SUP] 1 [/SUP], Jefferey L Burgess[SUP] 3 [/SUP], Alberto J Caban-Martinez[SUP] 4 [/SUP], Helen Y Chu[SUP] 2 [/SUP], Katherine D Ellingson[SUP] 3 [/SUP], Janet A Englund[SUP] 5 [/SUP], Kurt T Hegmann[SUP] 6 [/SUP], Zuha Jeddy[SUP] 7 [/SUP], Adam S Lauring[SUP] 8 [/SUP], Karen Lutrick[SUP] 3 [/SUP], Emily T Martin[SUP] 9 [/SUP], Clare Mathenge[SUP] 10 [/SUP], Jennifer Meece[SUP] 11 [/SUP], Claire M Midgley[SUP] 1 [/SUP], Arnold S Monto[SUP] 9 [/SUP], Gabriella Newes-Adeyi[SUP] 7 [/SUP], Leah Odame-Bamfo[SUP] 10 [/SUP], Lauren E W Olsho[SUP] 7 [/SUP], Andrew L Phillips[SUP] 6 [/SUP], Ramona P Rai[SUP] 7 [/SUP], Sharon Saydah[SUP] 1 [/SUP], Ning Smith[SUP] 12 [/SUP], Laura Steinhardt[SUP] 1 [/SUP], Harmony Tyner[SUP] 13 [/SUP], Meredith Vandermeer[SUP] 12 [/SUP], Molly Vaughan[SUP] 7 [/SUP], Sarang K Yoon[SUP] 6 [/SUP], Manjusha Gaglani[SUP] 10 [/SUP], Allison L Naleway[SUP] 12 [/SUP]
Affiliations
- PMID: 38319331
- DOI: 10.1001/jama.2023.27022
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.