Modern Inc.
MRNA 4.87%
began studying his Covid-19 vaccine in children aged six months to 11 years in the U.S. and Canada, the latest attempt to broaden the mass vaccination campaign beyond adults.
The company in Massachusetts, Massachusetts, said Tuesday that the first children received doses in the study that Moderna is doing 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 candidate for the COVID-19 vaccine in this important younger age population,” said Moderna CEO Stéphane Bancel.
The bulk of the U.S. vaccination campaign Covid-19 has so far focused on protecting adults, who are at higher risk for serious diseases caused by the coronavirus as children. Modern and Johnson & Johnsonsay
vaccines have been approved for use in adults 18 and older, while the Pfizer vaccine Inc.
and BioNTech SE have been cleaned for use in people 16 years and older.
Efforts have begun to test the Covid-19 vaccines in children, who may still become infected, both to protect them from the virus and to further build up the population’s immunity to move beyond pandemic restrictions.
Federal health officials have suggested that junior and high school students may have access to vaccines in the fall, followed by children of primary school age in early 2022.
Both Pfizer and Moderna began clinical trials last year to test their vaccines in adolescents 12 years and older. Both trials have fully enrolled subjects and the results are pending. J&J plans to start the vaccine with pediatric tests.
The new Moderna study, which is a combined phase 2 and 3 trial, aims to enroll about 6,750 children and is being conducted in two parts, according to the company.
The first part of the trial will test different doses of the vaccine in children. Researchers will examine the safety and immune response to the different doses to determine what should be transferred 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 Moderna’s vaccine or a placebo, 28 days apart. Researchers will track the safety, tolerance and efficacy of the vaccine.
They will determine the effectiveness of the vaccine in children by using an immune response marker, known as a correlate of protection – if determined – or by comparing their immune response to that seen in young adults, Moderna said.
Moderna did not provide a timetable for completing the study.
Write to Peter Loftus by [email protected]
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