With Robust Results, Moderna to Request Vaccine EUA for Kids Under 6

Child with mask getting vaccinated

Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age. The data showed a “robust neutralizing antibody response” in both cohorts. The doses were lower, a 25-microgram, two-shot series, than the 100 microgram doses used in adults.

Based on the results, the company plans to submit a request for an Emergency Use Authorization to the U.S. Food and Drug Administration for those age groups, as well as to the European Medicines Agency and other global regulators.

“We believe these latest results from the KidCOVE study are good news for parents of children under six years of age,” said Stephane Bancel, Moderna’s chief executive officer. “We now have clinical data on the performance of our vaccine from six months of age through older adults.”

He went on to say, “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 six 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.”

In the six months to two years and two years to six years groups, the safety and tolerability profile of the vaccine was consistent with what was seen in children six to 12 and adolescents 12 to 17 and in adults. Most adverse events were mild or moderate, being more common after the second dose.

The immunogenicity of the 25 microgram doses was similar to those observed with the 100-microgram two-dose shots in adults 17 to 25 years. Omicron (BA.1) was the dominant variant in the United States during the study period. As expected, the secondary endpoint of vaccine efficacy against Omicron was statistically significant but lower than what was seen against earlier variants, including Delta.

In children six months to two years, efficacy was 43.7% and in two years to six years, it was 37.5% against infection. Any infections seen were mild, with no severe cases observed. There were zero incidents of severe disease, hospitalizations or death.

No cases of myocarditis, a rare form of heart inflammation that has been associated with the vaccines, were observed.

According to the U.S. Centers for Disease Control and Prevention, during the Omicron surge beginning in late Dec. 2021, the hospitalization rate for infants and children up to the age of four was approximately five times the rate during the Delta surge in the summer and fall of 2021.

Most children in this age group are not eligible for a COVID-19 vaccine. The Pfizer-BioNTech vaccine has been authorized in people in the U.S. starting at the age of five, while Moderna’s is only authorized for adults.

In February, Pfizer and BioNTech indicated they were postponing their rolling application to the FDA for children under five after finding the two-shot regimen didn’t create a strong-enough immune response in the two-to-four-years age group. The Pfizer-BioNTech shots for youngest kids were very low, 3 micrograms, compared to Moderna’s 25 microgram shots.

The Moderna vaccine has been authorized in kids six to 12 in Australia, Canada and the European Union, and for adolescents 12 to 17 years in the E.U., U.K., Australia, Switzerland and other countries.

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