The pharmaceutical company Moderna has started a study testing its Covid vaccine in children under the age of 12, including babies as young as six months, the company said Tuesday.
The study is expected to enroll 6,750 healthy children in the United States and Canada. According to a spokeswoman, Colleen Hussey, Moderna declined to say how many had signed up or received their first recordings.
“There is a great demand for information about vaccination in children and how it works,” said Dr. David Wohl, the medical director of the University of North Carolina Vaccination Clinic, who is not involved in the study.
In a separate study, Moderna is testing its vaccine in 3,000 children ages 12-17 and could have results for that age group by summer. The vaccine would then have to be approved for use in children so that it would not be immediately available.
Many parents want protection for their children, and vaccinating children should help create the herd immunity that is believed to be critical to ending the pandemic. The American Academy of Pediatrics has called for vaccine studies to be expanded to include children.
Vaccine side effects like fever, sore arms, fatigue, and sore joints and muscles can be more intense in children than adults, and doctors say it’s important that parents know what to expect after their children are vaccinated.
Every child in Moderna’s study receives two recordings 28 days apart. The study will consist of two parts. In the first case, children aged 2 to under 12 can receive two doses of 50 or 100 micrograms each. People under the age of 2 may receive two exposures of 25, 50, or 100 micrograms.
March 16, 2021, 9:07 a.m. ET
In each group, the first children to be vaccinated are given the lowest doses and monitored for reactions before later participants are given higher doses.
Researchers then do an interim analysis to determine which dose is safest and most likely protective for each age group.
Children in Part 2 of the study receive the doses or placebo shots selected by the analysis, which consist of salt water.
Moderna developed its vaccine in collaboration with the National Institute for Allergies and Infectious Diseases. The company and the institute are working together with the Federal Agency for Biomedical Advanced Research and Development on the study.
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The children will be followed for a year to look for side effects and measure antibody levels, which will allow researchers to determine whether the vaccine appears to offer protection. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections with or without symptoms.
Dr. Wohl said the study was well designed and likely efficient, but asked why the children should only be observed for one year when adults in Moderna’s study were observed for two years. He also said he was a bit surprised that the vaccine was being tested in children so young so soon.
“Should we first learn what happens to the older children before we go to the really young children?” Asked Dr. Well. Most young children don’t get very sick from Covid, although some develop severe inflammatory syndrome that can be life-threatening.
Johnson & Johnson has also announced that it will test its coronavirus vaccine in babies and toddlers after first testing it in older children.
Pfizer-BioNTech is testing its vaccine in children ages 12-15 and plans to switch to younger groups. The product is already approved for use in the USA from the age of 16.
Last month, AstraZeneca began testing its vaccine in the UK in children 6 years and older.