Moderna Inc.
has begun studying its Covid-19 vaccine in children aged six months to 11 years in the U.S. and Canada, the latest effort to widen the mass-vaccination campaign beyond adults.
The Cambridge, Mass. company said Tuesday that the first children have received doses in the study, which Moderna is conducting in collaboration with the National Institute of Allergy and Infectious Diseases and a division of the Department of Health and Human Services.
“This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” Moderna Chief Executive
Stéphane Bancel
said.
The bulk of the U.S. Covid-19 vaccination campaign so far has focused on protecting adults, who are at higher risk of severe disease caused by the coronavirus than children. Moderna’s and
Johnson & Johnson’s
vaccines are authorized for use in adults 18 and older, while the vaccine from
Pfizer Inc.
and
BioNTech SE
is cleared for use in people 16 and older.
Efforts have begun to test the Covid-19 vaccines in children, who can still become infected, both to protect them from the virus and further build the population-level immunity to move past pandemic restrictions.
Federal health officials have suggested that if studies are positive, junior-high and senior-high students could get access to vaccines in the fall, followed by children of elementary-school age in early 2022.
Both Pfizer and Moderna last year started clinical trials testing their vaccines in adolescents aged 12 years and older. Both trials have fully enrolled subjects and the results are pending. J&J is planning to start pediatric testing of its vaccine.
The new Moderna study, which is a combined Phase 2 and 3 trial, will aim to enroll about 6,750 children and will be conducted in two parts, according to the company.
The first part of the trial will test different dose levels of the vaccine in children. Researchers will examine the safety and immune response to the various doses to determine which to carry into the second part of the study.
In the study’s second part, other study subjects will be randomly assigned to receive two doses of either Moderna’s vaccine or a placebo, 28 days apart. Researchers will track the safety, tolerability and effectiveness of the vaccine.
They will determine effectiveness of the vaccine in children either by using an immune-response marker known as a correlate of protection—if one is determined—or by comparing their immune responses to those seen in young adults, Moderna said.
Moderna didn’t give a timetable for completing the study.
Write to Peter Loftus at [email protected]
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