Modern Inc.
MRNA 4.87%
began studying the 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.
Cambridge, Massachusetts, 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 vaccine candidate in this important younger population,” said Moderna chief executive Stéphane Bancel.
Most of the US Covid-19 vaccination campaign has so far focused on protecting adults, who have a higher risk of severe coronavirus disease than children. Modern and Johnson & JohnsonS
vaccines are authorized for use in adults over 18 years of age, 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 further build population-level immunity to overcome pandemic restrictions.
Federal health officials have suggested that if the studies are positive, high school 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 that tested their vaccines in teens 12 and older. Both studies have fully enrolled subjects and the results are pending. J&J intends to begin pediatric testing of its vaccine.
The new Moderna study, which is a combined phase 2 and 3 study, will aim to enroll approximately 6,750 children and will be conducted in two parts, according to the company.
The first part of the study will test different doses of the vaccine in children. The researchers will examine the safety and immune response at different doses to determine which ones to transport in the second part of the study.
In the second part of the study, other subjects in the study will be randomly assigned to receive two doses of either a Modern vaccine or a placebo at a distance of 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 protective correlate – if determined – or by comparing their immune responses with those seen in young adults, Moderna said.
Moderna did not give a timetable for completing the study.
Write to Peter Loftus at [email protected]
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