Modern Inc.
MRNA 4.87%
began studying its Covid-19 vaccine in children aged six months to 11 years in the United States and Canada, the latest effort to extend the mass vaccination campaign beyond adults.
Cambridge, Massachusetts, said on Tuesday that the first children received doses of 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 safety and immunogenicity potential of our candidate vaccine COVID-19 in this important young population,” said Moderna’s chief executive, Stéphane Bancel.
Most of Covid-19’s vaccination campaign in the United States has so far focused on protecting adults, who are at greater risk of serious coronavirus diseases than children. Moderna’s and Johnson & Johnsonin
vaccines are authorized for use in adults aged 18 and over, while the Pfizer vaccine Inc.
and BioNTech SE is released for use by people aged 16 and over.
We have started efforts to test Covid-19 vaccines in children, who can still be infected, both to protect them from the virus and to increase population immunity to overcome pandemic restrictions.
Federal health officials have suggested that if studies are positive, elementary and high school students may have access to vaccines in the fall, followed by schoolchildren in early 2022.
Both Pfizer and Moderna started clinical trials last year testing their vaccines on teenagers aged 12 and over. Both trials involved fully enrolled individuals and the results are pending. J&J is planning to start pediatric testing of its vaccine.
The new Moderna study, which is a combined trial of Phase 2 and 3, 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 one to take to the second part of the study.
In the second part of the study, other study participants will be randomly assigned to receive two doses of Moderna vaccine or a placebo, 28 days apart. The researchers will monitor the vaccine’s safety, tolerability and effectiveness.
They will determine the vaccine’s effectiveness in children using an immune response marker known as a protective correlate – if any – or by comparing their immune responses to those seen in young adults, Moderna said.
Moderna did not provide a timetable for completing the study.
Write to Peter Loftus at [email protected]
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