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Moderna announced its COVID-19 mRNA vaccine triggers a strong immune response in children ages 6-11 years, comparable to the boost reported previously in teenagers and adults.
These first interim phase 2/3 study results also show the vaccine has a favorable safety profile in this age group.
The seroresponse rate of 99.3% in 6- to 11-year-old participants in the KidCOVE study, for example, was within 0.6% of the rate seen in young adults in the Moderna phase 3 trial.
A total of 4753 healthy children participated in the randomized, blinded, placebo-controlled KidCOVE study. Researchers assessed neutralizing antibody levels after two 50 microgram doses of the company’s mRNA-1273 vaccine administered 28 days apart.
The SARS-Cov-2-neutralizing antibody geometric mean ratio (GMR) comparing the response in children to the response in young adults from the phase 3 COVE study was 1.5 (95% CI, 1.3 – 1.8). These results demonstrate strong immune response in this cohort of children 1 month after the second dose and met the co-primary immunogenicity endpoints, according to a company news release.
Moderna plans to submit these data to the FDA and other regulatory agencies worldwide as part of its request for authorization of the vaccine in this age group.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, Moderna chief executive officer, in the news release.
The Moderna announcement comes just three days after the FDA found that the benefits outweighed the risks associated with two doses of the Pfizer/BioNTech mRNA vaccine in children 5-11 years old. Also last week, the White House announced its plans for vaccinating American children.
In the KidCOVE study, mRNA-1273 was generally well tolerated with a safety and tolerability profile also generally consistent with the phase 3 COVE study in adolescents and adults, the company reports. The majority of adverse events were mild or moderate in severity and included fatigue, headache, fever, and injection site pain.
Participants will continue to be monitored for safety and effectiveness for 12 months after their second injection. Although enrollment in KidCOVE is complete for 6- to 11-year-old children, recruitment of children from 6 months to under 6 years continues.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.