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Safety and Immunogenicity of an mRNA-1273 Booster in Children
Vladimir Berthaud1, C Buddy Creech2, Christina A Rostad3
1Meharry Medical College-Division of Infectious Diseases, Clinical and Translational Research Center, Nashville, Tennessee, USA.
Insights
The mRNA-1273 COVID-19 vaccine booster demonstrated a favorable safety profile and robust immunogenicity in children aged 6 months to 11 years. These findings support its use as a booster dose in this pediatric population.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Immunology
Background:
- The mRNA-1273 vaccine's primary series showed acceptable safety and immunogenicity in children aged 6 months to 11 years.
- This study evaluated the safety and immunogenicity of an mRNA-1273 booster dose in pediatric participants.
Purpose of the Study:
- To assess the safety and reactogenicity of an mRNA-1273 booster dose in children aged 6 months to 11 years.
- To evaluate the immunogenicity of the mRNA-1273 booster dose by comparing neutralizing antibody responses in children to those in young adults who received the primary series.
Main Methods:
- Participants aged 6 months to 11 years received an mRNA-1273 booster dose (10 µg for younger, 25 µg for older) at least 6 months after primary vaccination.
- Safety and reactogenicity data were collected, along with neutralizing antibody (nAb) levels.
- Immunogenicity was assessed by comparing nAb responses in children post-booster to nAb responses in young adults post-primary series.
Main Results:
- A total of 153 children (6 months-5 years) and 2519 children (6-11 years) received the booster dose.
- The booster dose exhibited a safety profile consistent with the primary series, with no new safety concerns identified.
- The mRNA-1273 booster elicited strong neutralizing antibody responses against SARS-CoV-2 in children, meeting noninferiority criteria compared to young adults.
Conclusions:
- The mRNA-1273 booster dose demonstrated a favorable safety profile in children aged 6 months to 11 years.
- Robust immunogenicity was observed following the mRNA-1273 booster dose in this pediatric age group.
- Data support the use of the mRNA-1273 booster dose for children aged 6 months to 11 years.
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).
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