- Two 25 μg doses of mRNA-1273 in participants 6 months to under 6 years met primary endpoint with robust neutralizing antibody titers similar to adults mRNA-1273 was generally well tolerated in this age group
- Although not a primary endpoint, statistically significant vaccine efficacy was observed during the Omicron wave that was consistent with the lower two-dose effectiveness against Omicron seen in adults
- Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children 6 months to under 6 years of age
- Additionally, Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age; mRNA-1273 is approved for use in this age group in Europe, Canada and Australia
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age. This interim analysis showed a robust neutralizing antibody response in both age groups after a 25 µg two-dose primary series of mRNA-1273 along with a favorable safety profile.
Based on these data, Moderna will submit a
request for authorization of a 25 μg two-dose primary series of mRNA-1273 for
children 6 months to under 6 years of age to the U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA) and other global
regulators in the coming weeks.
"We believe these latest results from
the KidCOVE study are good news for parents of children under 6 years of age.
We now have clinical data on the performance of our vaccine from infants six
months of age through older adults," said Stéphane Bancel, Chief Executive
Officer of Moderna. "Given the need for a vaccine against COVID-19 in
infants and young children we are working with the U.S. FDA and regulators
globally to submit these data as soon as possible.
Additionally, after consultation with the
U.S. FDA we have initiated a submission for emergency use authorization of our
COVID-19 vaccine in children ages 6 to 11 years old and are updating our
submission to the FDA for emergency use authorization of mRNA-1273 in
adolescents ages 12 to 17 years with additional follow-up data. We remain
committed to helping to end the COVID-19 pandemic with a vaccine for children
of all ages."
KidCOVE is a randomized, observer-blind,
placebo-controlled study to evaluate the safety, tolerability, and
immunogenicity of two doses of mRNA-1273 given to healthy children 28 days
apart. The study population is divided into three age groups (6 to <12
years, 2 to <6 years, and 6 months to <2 years).
In the study, efficacy could be evaluated
if enough cases accrued. Overall, the Company has enrolled approximately 11,700
pediatric participants in the U.S. and Canada into the trial including
approximately 4,200 children ages 2 to under 6 years and approximately 2,500
children ages 6 months to under 2 years.
Today, Moderna is reporting on the 6 months
to under 2 years and 2 years to under 6 years age groups. Approximately 6,700
participants 6 months to under 6 years of age were enrolled into this age
cohort.
In both age groups, the tolerability
profile was generally consistent with that observed in children age 6 to under
12, in adolescents age 12 to 17, and in adults. The majority of adverse events
were mild or moderate and were more frequently reported after dose two.
Rates of fever greater than 38°C among
vaccine recipients were consistent with other commonly used and recommended
pediatric vaccines and were 17.0% and 14.6% in the 6 months to under two years
and the two to under six years age groups, compared to 23.9% in the six to
under 12 years age group, which received a 50 µg two-dose primary series.
Fever greater than 40°C was seen in only a
few children (0.2% in each age group). No study pause rules were met, and no
new safety concerns were identified in either age group. No deaths, no
myocarditis or pericarditis, and no multisystem inflammatory syndrome in
children (MIS-C) were reported.
In both age groups, two doses of 25 µg
provided similar immunogenicity to the 100 µg two-dose primary series in adults
ages 18 to 25 years, meeting the non-inferiority criteria and immunobridging[1],
and indicating that the benefit of mRNA-1273 conferred to adults ages 18 to 25
are also conferred to children and infants as young as 6 months.
SARS-Cov-2-neutralizing antibody geometric
mean ratio (GMR) comparing the response in children 6 months to under 2 years
to the response in young adults from the Phase 3 COVE study was 1.3 (95% Cl:
1.1, 1.5) and was 1.0 (95% Cl: 0.9, 1.2) for the 2 to under 6 years age group.
This also predicts protection from COVID-19 and severe COVID-19 disease down to
6 months of age.
The Omicron SARS-CoV-2 variant predominated
in the U.S. during the KidCOVE study in these younger age groups. The secondary
endpoint of vaccine efficacy confirms statistically significant, but lower
efficacy against COVID-19 infection as expected during the Omicron wave and
consistent with adult observational data. Using the Phase 3 COVE study COVID-19
definition, vaccine efficacy in children 6 months to 2 years was 43.7% and
vaccine efficacy was 37.5% in the 2 to under 6 years age group.
In this case, statistically significant is
defined as a lower bound on the 95% confidence interval which is greater than
0. The majority of cases were mild, and no severe COVID-19 disease was observed
in either age group. The absence of any severe disease, hospitalization or
death in the study precludes the assessment of vaccine efficacy against these
endpoints.
Similar to adults, Moderna is preparing to
evaluate the potential of a booster dose for all pediatric populations,
including those age 6 months to under 6 years, 6 to under 12 years, and
adolescents. The Company is evaluating booster doses of mRNA-1273 and its
bivalent booster candidate (mRNA-1273.214), which includes Omicron variant
booster and mRNA-1273.
Safety data continue to accrue, and the
study continues to be monitored by an independent safety monitoring committee.
All participants will be monitored for 12 months after their second injection
to assess long-term protection and safety. These data are subject to change
based on ongoing data collection. The Company plans to submit these data to a
peer-reviewed publication.
Moderna previously reported positive
topline data from the 6 to under 12 year old cohort, indicating a strong immune
response one month after the second dose. The co-primary immunogenicity
endpoints in this age group were met.
Today, Moderna also announced that the
Company has initiated the submission process with the U.S. FDA for an emergency
use authorization of a 50 μg two-dose primary series of mRNA-1273 for the 6 to
under 12 years cohort. Regulators in Australia, Canada and the European Union
have authorized the use of mRNA-1273 in this age group.
Moderna will update its submission to the
U.S. FDA for the emergency use of a 100 μg two-dose primary series in
adolescents ages 12 to under 18 years. Moderna has received regulatory
authorizations for the 100 µg two-dose primary series in adolescents 12 to 17
years of age in the European Union, UK, Australia, Canada, Switzerland and
other countries.
The KidCOVE study is being conducted in collaboration
with the National Institute of Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health (NIH) and the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the Assistant
Secretary for Preparedness and Response at the U.S. Department of Health and
Human Services. The ClinicalTrials.gov identifier is NCT04796896.
BARDA, part of ASPR within the U.S. HHS is supporting the continued research and development of the Company's COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.
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