Modern Inc.
MRNA 4.87%
has begun studying its Covid-19 vaccine in children aged six months to 11 years in the United States and Canada, the latest effort to expand the mass vaccination campaign beyond adults.
The Cambridge, Massachusetts 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 population,” said Moderna chief executive Stéphane Bancel.
The bulk of the U.S. Covid-19 vaccination campaign so far has focused on protecting adults, who have a higher risk of developing serious coronavirus disease than children. Moderna’s and Johnson & Johnson‘s
vaccines are authorized for use in adults over the age of 18, while the Pfizer vaccine Inc.
and BioNTech SE is authorized for use in persons over 16 years of age.
Efforts have begun to test Covid-19 vaccines in children, who can still become infected, both to protect them from the virus and to increase immunity at the population level to overcome pandemic restrictions.
Federal health officials have suggested that if studies are positive, high school and high school students could access vaccines in the fall, followed by children in primary school in early 2022.
Both Pfizer and Moderna last year began clinical trials testing their vaccines in teens 12 years of age and older. Both essays have fully enrolled subjects and the results are pending. J&J plans to begin pediatric testing of its vaccine.
The new Modern study, which is a combined Phase 2 and 3 trial, will aim to enroll nearly 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. The researchers will examine the safety and immune response at the various doses to determine which one to take in the second part of the study.
In the second part of the study, other study subjects will be randomly assigned to receive two doses of the Moderna vaccine or a placebo, separated by 28 days. Researchers will monitor the safety, tolerability and efficacy of the vaccine.
They will determine the effectiveness of the vaccine in children, either by using an immune response marker known as a protection correlate (if determined) or by comparing their immune responses to those seen in young adults, dir Modern.
Modern did not give a timetable to complete the study.
Write to Peter Loftus to [email protected]
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