Moderna Inc.
MRNA 4.87%
has begun testing its Covid-19 vaccine in children between six months and 11 years in the U.S. and Canada, the latest attempt to extend the major vaccine campaign beyond adulthood.
The Cambridge company, Mass., Said. Tuesday that the first children have received doses in the study, which Moderna is conducting in collaboration with the National Institute of Allergies and Infectious Diseases and a department of the Department of Health and Human Services.
“This pediatric study will help us assess the safety and immunogenicity of our COVID-19 vaccine candidate in this important young age population,” said Moderna CEO Stéphane Bancel.
Most of the U.S. Covid-19 vaccination campaign to date has focused on the protection of adults, who are at greater risk of severe coronary virus-induced infection than children. Moderna’s and Johnson & Johnson‘s
vaccines are authorized for use in adults 18 and over, and the Pfizer vaccine Inc.
and BioNTech SE purified for use in people 16 and older.
Efforts have begun to test the Covid-19 vaccines in children, who may still be infected, both to protect them from the virus and to raise the level of population immunity to pass. on pandemic restrictions.
Federal health officials have suggested that, if studies are positive, high- and high-school students could access vaccines in the fall, and then children of primary school age in early 2022.
Both Pfizer and Moderna last year began clinical trials testing their vaccines in adolescents aged 12 years and older. Both tests are on fully recorded topics and the results are pending. J&J plans to start a pediatric trial on his vaccine.
Moderna’s new study, which is a combined Phase 2 and 3 test, 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. Researchers will study the safety and immune response of the different doses to determine what should be included in the second part of the study.
In the second part of the study, other study subjects will be randomized to receive two doses of Moderna or placebo vaccine, 28 days apart. Researchers will monitor the safety, tolerability and effectiveness of the vaccine.
They test the effectiveness of the vaccine in children either by using a protective response signal called a protective correlation – if one is diagnosed – or by comparing their immune responses. to those seen in young adults, Moderna said.
Moderna did not provide a timetable for completion of the study.
Web browser alerts and tools can help you schedule a Covid-19 vaccination meeting. Joanna Stern at WSJ met with Kris Slevens, an IT man who has organized more than 300 meetings for seniors in New Jersey, to learn the best tricks to compete in the Hunger Games that vaccine retention. Photo: Emil Lendof for The Wall Street Journal
Write to Peter Loftus at [email protected]
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