[ad_1]
Modern Inc.
MRNA 4.87%
has begun studying its Covid-19 vaccine in children ages six months to 11 years in the US and Canada, the latest effort to expand the mass vaccination campaign beyond adults.
The Cambridge, Massachusetts company said Tuesday that the first children 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 candidate vaccine in this significant younger age population,” said Moderna CEO Stéphane Bancel.
Most of the US Covid-19 vaccination campaign so far has focused on protecting adults, who are at higher risk of serious illness caused by the coronavirus than children. Moderna’s and Johnson & Johnson‘s
The vaccines are licensed for use in adults 18 years of age and older, while the Pfizer vaccine Inc.
and BioNTech SE is licensed for use by persons 16 years of age and older.
Efforts have begun to test Covid-19 vaccines in children, who may still become infected, both to protect them from the virus and to further develop immunity at the population level to overcome pandemic restrictions.
Federal health officials have suggested that if the studies are positive, middle and high school students could have access to 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 teens 12 and older. Both trials have fully enrolled subjects and the results are pending. J&J plans to begin 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. The 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 second part of the study, other study subjects will be randomly assigned to receive either two doses of Moderna’s vaccine or a placebo, 28 days apart. Researchers will monitor the safety, tolerability, and efficacy of the vaccine.
They will determine the effectiveness of the vaccine in children using an immune response marker known as a correlate of protection, if determined, or by comparing their immune responses with those seen in young adults, Moderna said.
Moderna did not give a timeline for completing the study.
Write to Peter Loftus at [email protected]
Copyright © 2020 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8
