Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Dec 17;79(6):1524-1532.
doi: 10.1093/cid/ciae420.

Safety and Immunogenicity of an mRNA-1273 Booster in Children

Vladimir Berthaud  1 , C Buddy Creech  2 , Christina A Rostad  3 , Quito Carr  4 , Liberation de Leon  5 , Monika Dietrich  6 , Anil Gupta  7 , David Javita  8 , Sharon Nachman  9 , Swetha Pinninti  10 , Mobeen Rathore  11 , Carina A Rodriguez  12 , Katherine Luzuriaga  13 , William Towner  14 , Anne Yeakey  15 , Mollie Brown  16 , Xiaoping Zhao  16 , Weiping Deng  16 , Wenqin Xu  16 , Honghong Zhou  16 , Bethany Girard  16 , Roxanne Kelly  16 , Karen Slobod  17 , Evan J Anderson  3 , Rituparna Das  16 , Jacqueline Miller  16 , Sabine Schnyder Ghamloush  16
Affiliations
Clinical Trial

Safety and Immunogenicity of an mRNA-1273 Booster in Children

Vladimir Berthaud et al. Clin Infect Dis. .

Abstract

Background: A 2-dose mRNA-1273 primary series in children aged 6 months-5 years (25 µg) and 6-11 years (50 µg) had an acceptable safety profile and was immunogenic in the phase 2/3 KidCOVE study. We present data from KidCOVE participants who received an mRNA-1273 booster dose.

Methods: An mRNA-1273 booster dose (10 µg for children aged 6 months-5 years; 25 µg for children aged 6-11 years; age groups based on participant age at enrollment) was administered ≥6 months after primary series completion. The primary safety objective was the safety and reactogenicity of an mRNA-1273 booster dose. The primary immunogenicity objective was to infer efficacy of an mRNA-1273 booster dose by establishing noninferiority of neutralizing antibody (nAb) responses after a booster in children versus nAb responses observed after the mRNA-1273 primary series in young adults (18-25 years) from the pivotal efficacy study. Data were collected from March 2022 to June 2023.

Results: Overall, 153 (6 months-5 years) and 2519 (6-11 years) participants received an mRNA-1273 booster dose (median age at receipt of booster: 2 and 10 years, respectively). The booster dose safety profile was generally consistent with that of the primary series in children; no new safety concerns were identified. An mRNA-1273 booster dose elicited robust nAb responses against ancestral SARS-CoV-2 among children and met prespecified noninferiority success criteria versus responses observed after the primary series in young adults.

Conclusions: Safety and immunogenicity data support administration of an mRNA-1273 booster dose in children aged 6 months to 11 years.

Clinical trials registration: NCT04796896 (Clinicaltrials.gov).

Keywords: COVID-19; SARS-CoV-2; booster dose; children; mRNA-1273.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. M. B., X. Z., W. D., W. X., H. Z., B. G., R. K., E. J. A., R. D., J. M., and S. S. G. are employees of Moderna, Inc, and hold stock/stock options in the company. A. Y. and K. S. are consultants and were contracted by Moderna, Inc, for this study. V. B. has received institutional research support from Moderna, Inc, GSK-ViiV, Gilead Sciences, Inc, and Novavax, Inc. C. B. C. has consulted for Pfizer, Inc, Moderna, Inc, GSK plc, Vir Biotechnology, CommenseBio, Cowen Investment Management LLC, Sanofi S.A., and Guidepoint Global. C. A. Rostad has received institutional support from Moderna, Inc, BioFire, Inc, GSK plc, MedImmune, Micron Technology, Inc, Janssen Pharmaceuticals, Merck & Co, Inc, Novavax, PaxVax, Pfizer, Inc, Regeneron, Sanofi Pasteur, and from the National Institutes of Health (NIH). She is coinventor of patented respiratory syncytial (RSV) vaccine technology, which has been licensed to Meissa Vaccines, Inc. E. J. A. has consulted for Pfizer, Inc, Sanofi Pasteur, GSK plc, Janssen Pharmaceuticals, Moderna, Inc, and Medscape, and his institution received funds to conduct clinical research unrelated to this manuscript from MedImmune LLC, Regeneron Pharmaceuticals, Inc, PaxVax, Pfizer, Inc, GSK plc, Merck & Co, Inc, Sanofi Pasteur, Janssen Pharmaceuticals, and Micron Technology, Inc. E. J. A. served on a safety monitoring board for Kentucky BioProcessing, Inc, and Sanofi Pasteur. E. J. A. served on a data adjudication board for WCG and ACI Clinical and his institution received funding from the NIH to conduct clinical trials of COVID-19 vaccines. K. L. has consulted for Gilead Sciences, Inc, has received research funding from the NIH and Moderna, Inc, and has received funding for clinical research from Gilead Sciences, Inc, Moderna, Inc, and Pfizer, Inc. C. A. Rodriguez has received institutional research support from Moderna, Inc, Novavax, Inc, and Gilead Sciences, Inc. M. D. has received clinical trial funding from Moderna, Inc, and Gilead Sciences, Inc. W. T. has received institutional research support from Moderna, Inc, Pfizer, Inc, Janssen Pharmaceuticals, GSK plc, ViiV Healthcare Limited, and AstraZeneca plc. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Disposition by age group. Eligible participants who received a prior 2-dose primary series of mRNA-1273 (6 months–5 years: 2 doses of mRNA-1273 25 µg; 6–11 years: 2 doses of mRNA-1273 50 µg) and received a booster dose of mRNA-1273 ≥6 months after the second dose. For the cohort aged 6 months–5 years (n = 153), participants received a 10-µg booster dose of mRNA-1273; those aged 6–11 years (n = 2519) received a 25-µg booster dose of mRNA-1273. Data cutoff date was 1 June 2023. Abbreviations: COVID-19, coronavirus disease 2019; EUA, Emergency Use Authorization.
Figure 2.
Figure 2.
Local reactions and systemic events after booster vaccination by age group. The percentage of participants reporting local (A) or systemic (B) events by grade within 7 days of receiving a booster dose of mRNA-1273. Numbers of participants derived from the solicited safety set: 6 –23 months, n = 122; 2–5 years, n = 31; 6–11 years, n = 2487.
Figure 3.
Figure 3.
Binding antibody levels against ancestral SARS-CoV-2, Delta (AY.4) variant, and Omicron BA.1 variant after booster vaccination among children aged 6 months–11 years with pre-booster SARS-CoV-2–negative status (per-protocol immunogenicity, SARS-CoV-2–negative set). Binding antibody responses were assessed at baseline (day 1), day 209 following primary series vaccination, booster dose day 1 (pre-booster), and booster day 29 among participants with no evidence of current or prior SARS-CoV-2 infection at the pre-booster visit (n = 76, 6 months–5 years; n = 145, 6–11 years). Pre-booster SARS-CoV-2–negative status was defined as having a negative RT-PCR test and negative serology test (based on binding antibody specific to SARS-CoV-2 nucleocapsid as measured by Roche Elecsys Anti-SARS-CoV-2 assay) at the date of the booster dose. Abbreviations: CI, confidence interval; RT-PCR, reverse transcriptase–polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
See this image and copyright information in PMC

References

    1. Delahoy MJ, Ujamaa D, Taylor CA, et al. Comparison of influenza and coronavirus disease 2019-associated hospitalizations among children younger than 18 years old in the United States: FluSurv-NET (October-April 2017–2021) and COVID-NET (October 2020-September 2021). Clin Infect Dis 2023; 76:e450–9. - PMC - PubMed
    1. Havers FP. COVID-19-associated hospitalizations among infants, children and adults—COVID-NET, January-August 2023. Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (US). Coronaviruses and Other Respiratory Viruses Division, Surveillance and Prevention Branch, RESP-NET Hospitalization Surveillance Team, 2023.
    1. Anderson EJ, Creech CB, Berthaud V, et al. Evaluation of mRNA-1273 vaccine in children 6 months to 5 years of age. N Engl J Med 2022; 387:1673–87. - PMC - PubMed
    1. Creech CB, Anderson E, Berthaud V, et al. Evaluation of mRNA-1273 Covid-19 vaccine in children 6 to 11 years of age. N Engl J Med 2022; 386:2011–23. - PMC - PubMed
    1. Chiew CJ, Premikha M, Chong CY, et al. Effectiveness of primary series and booster vaccination against SARS-CoV-2 infection and hospitalisation among adolescents aged 12–17 years in Singapore: a national cohort study. Lancet Infect Dis 2023; 23:177–82. - PMC - PubMed

Publication types

MeSH terms

Associated data