Two Doses of Moderna’s COVID-19 Vaccine Effective in Children
In the Phase 2/3 trial, two 50-microgram doses of Moderna’s COVID-19 vaccine elicited robust neutralizing antibody response and a favorable safety profile.
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By - Moderna recently announced that two doses of its COVID-19 vaccine showed a robust neutralizing antibody response in children six to under 12 years of age.
The Phase 2/3 KidCOVE randomized expansion study evaluated mRNA-1273 at the 50 microgram dose level 28 days apart in 4,753 children.
In the trial, the SARS-CoV-2 neutralizing antibody geometric mean ratio comparing the response in children to young adults was 1.5, with a seroresponse rate of 99.3 percent. These results show strong immune responses one month after the second dose.
Notably, mRNA-1273 was generally well-tolerated with a safety profile consistent with the Phase 3 COVE study in adolescents and adults.
“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,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages,” Bancel continued.
Enrollment for children six to under 12 years of age is complete. But the Phase 2/3 study will continue to enroll children ages 6 months to under 6 years of age. So far, Moderna has enrolled nearly 5,700 pediatric participants in the US and Canada in the trial as a whole.
Researchers will continue to monitor patients for 12 months after the second dose to assess long-term protection and safety. And the company will submit data from the study to a peer-reviewed publication.
In May 2021, Moderna announced that mRNA-1273 was 93 percent effective in seronegative participants starting 14 days after the second dose. And after two doses, there were no cases of coronavirus cases in the vaccine group, compared to four cases in the placebo group.
And most recently, CDC recommended a booster dose of mRNA-1273 for all eligible individuals who receive any authorized vaccine.
Specifically, the organization unanimously recommended the booster dose for individuals 65 years of age and older, people aged 18 to 64 who are at high risk of severe COVID-19, and people aged 18 to 64 with frequent exposure to the virus.
Moderna estimated that the authorization of the booster dose and subsequent approval could result in up to 1 billion extra doses available for distribution in 2022.
