Compilenewborn
Recently, Moderna announced positive interim data from the Phase 2/3 KidCOVE study of its COVID-19 vaccine (mRNA-1273)
.
The study was conducted in children 6 months to 2 years old and 2 years old to under 6 years old, and the interim analysis showed that the 25µg two-dose immunization schedule showed strong neutralizing antibody responses and good safety in both age groups.
sex
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Based on these data, Moderna will submit a license application in the coming weeks to the U.
S.
FDA, European Medicines Agency and other global regulators to administer the mRNA-1273 vaccine 25µg two-dose immunization schedule to children 6 months to under 6 years of age
.
KidCOVE is a randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of two doses of mRNA-1273, 28 days apart, in a population of healthy children
.
The study population was divided into 3 age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years)
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In this study, efficacy can be assessed if a sufficient number of cases are accumulated
.
Overall, Moderna has enrolled approximately 11,700 pediatric participants in the U.
S.
and Canada, including approximately 4,200 children 2 to under 6 years of age and approximately 2,500 children 6 months to under 2 years of age
.
Data are reported for the age groups 6 months to under 2 years and 2 years to under 6 years
.
In both age groups, the tolerability profile of the mRNA-1273 vaccine was largely consistent with that observed in children aged 6 to under 12 years, adolescents aged 12 to 17 years, and adults
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Most adverse events were mild or moderate and were reported more frequently after the second vaccination
.
The rate of fever above 38°C in the vaccinated population was consistent with other commonly used and recommended pediatric vaccines, at 17.
0% and 14.
6% in the 6 months to under 2 and 2 to under 6 age groups, respectively, and in the 6-year 23.
9% in the age group below 12 years (2-dose schedule of 50 µg for this age group)
.
Fever above 40°C occurred in only a few children (0.
2% in each age group)
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Neither age group met study suspension rules and no new safety concerns were identified
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No deaths, myocarditis or pericarditis, and multisystem inflammatory syndrome in children (MIS-C) were reported
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In these 2 age groups, the immunogenicity of the two-dose 25-µg immunization was similar to that of the 100-µg two-dose immunization in adults 18 to 25 years old, meeting noninferiority criteria and immune bridging, indicating that mRNA-1273 was 18-25 The benefits for adults as young as 6 months are also available to children and infants as young as 6 months old
.
The SARS-Cov-2 neutralizing antibody geometric mean ratio (GMR) results were compared between the responses in the 6 months to <2 years old age group and the 2 to <6 years old age group with the responses of young adults in the phase 3 COVE study.
is 1.
3 (95%Cl: 1.
1, 1.
5), 1.
0 (95% Cl: 0.
9, 1.
2)
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This also heralds the protective effect of mRNA-1273 against COVID-19 and severe COVID-19 disease, with benefit populations as young as 6 months old
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During the KidCOVE study in these young populations, the Omicron variant of SARS-CoV-2 was circulating in the United States
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The secondary endpoint of vaccine efficacy demonstrated statistical significance, but, as expected, was less effective in preventing COVID-19 infection during the Omicron epidemic, consistent with observational data in adults
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Using the Phase 3 COVE study COVID-19 definitions, vaccine efficacy was 43.
7% in the 6 months to 2 year age group and 37.
5% in the 2 to under 6 year age group
.
In this case, statistical significance was defined as the lower bound of the 95% confidence interval greater than 0
.
Most cases were mild, with no severe COVID-19 disease observed in either age group
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The efficacy of mRNA-1273 to prevent these endpoints could not be assessed as there were no serious illnesses, hospitalizations, or deaths in the study
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Similar to adults, Moderna is preparing to evaluate the potential of the mRNA-1273 vaccine booster in all pediatric populations, including 6 months to <6 years, 6 to <12 years, and adolescents
.
Currently, the company is evaluating a booster shot of mRNA-1273 and a bivalent vaccine candidate (mRNA-1273.
214), which is a complex of the Omicron-specific booster vaccine candidate with mRNA-1273
.
Reference source: Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint
