Modern Inc.
MRNA 4.87%
has begun to study the Covid-19 vaccine in children aged 6 months to 11 years in the US and Canada, the latest effort to extend the mass vaccination campaign to adults.
The Cambridge, Massachusetts-based company said Tuesday that the first children have been given doses in the study that Moderna is conducting in conjunction 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 group,” said Stéphane Bancel, Chief Executive of Moderna.
Most of the US Covid-19 vaccination campaign to date has focused on protecting adults, who are at greater risk of serious coronavirus disease than children. Moderna’s and Johnson & Johnson‘s
vaccines are approved for use in adults 18 and older, while the vaccine from Pfizer Inc.
and BioNTech SE is approved for use in people 16 years of age 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 to further build population-level immunity to get past pandemic limitations.
Federal health officials have suggested that if the studies are positive, junior-high and senior-high students may be able to access vaccines in the fall, followed by elementary school-age children in early 2022.
Both Pfizer and Moderna began clinical trials last year testing their vaccines in adolescents 12 years and older. Both studies have fully enrolled subjects and the results are pending. J&J plans to begin pediatric testing of its vaccine.
The new Moderna trial, a combined phase 2 and phase 3 trial, aims to enroll approximately 6,750 children and will be conducted in two parts, according to the company.
In the first part of the trial, different dose levels of the vaccine are tested in children. Researchers will examine the safety and immune response to the different doses to determine which one to take to the second part of the study.
In the second part of the study, other subjects will be randomly assigned to receive two doses of the Moderna vaccine or a placebo, 28 days apart. Researchers will monitor the safety, tolerability, and effectiveness of the vaccine.
They will determine the effectiveness of the vaccine in children by either using an immune response marker known as a correlate of protection – if one is determined – or by comparing their immune responses to those in young adults, Moderna said.
Moderna did not provide a timetable for the completion of the study.
Write to Peter Loftus at [email protected]
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