Drug company Moderna has begun a study that will test its Covid vaccine in children under 12, including babies up to six months, the company said Tuesday.
The study is expected to enroll 6,750 healthy children in the United States and Canada.
“There’s a big question to find out about vaccinating children and what they do,” says Dr. David Wohl, the medical director of the vaccine clinic at the University of North Carolina, who is not involved in the study.
In a separate study, Moderna tested the vaccine in 3,000 children aged 12 to 17 years.
Many parents want protection for their children, and vaccinating children should help bring about the herd immunity that is considered important in stopping the pandemic. The American Academy of Pediatrics has called for the expansion of vaccination trials to include children.
Every child in Moderna’s study gets two shots, 28 days apart. The study will consist of two parts. In the first, children from 2 years to less than 12 years may receive two doses of 50 or 100 micrograms each. People under 2 years of age can receive two shots of 25, 50 or 100 micrograms.
In each group, the first children vaccinated will receive the lowest doses and they will be monitored for responses before later participants receive higher doses.
Researchers will then conduct an interim analysis to determine which dose is the safest and most effective for each age group.
Children in part two of the study received the doses selected by the analysis – or placebo shots consisting of saline.
The children will be followed for a year to look for side effects and measure antibody levels that will help researchers determine if the vaccine is effective. The antibody levels will be the main indicator, but the researchers will also look for coronavirus infections, with or without symptoms.
Dr. Wohl said the study looks well-designed and is likely to be effective, but he questioned why the children should only be followed for one year, when adults in Moderna’s study are followed for two years. He also said he was somewhat surprised to see that the vaccine would soon be tested in children so young.
“Should we first learn what happens to the older children before we go to the very young children?” Ask Dr. Wohl. Most young children do not get very sick from Covid, although he develops a serious inflammatory syndrome that can be life-threatening.
Johnson & Johnson also said they would test the coronavirus vaccine in infants and young children after it was first tested in older children.
Pfizer-BioNTech is testing the vaccine in children aged 12 to 15 and said it plans to move to younger groups; the product is already approved for use in those 16 and older in the United States.
Last month, AstraZeneca started testing its vaccine in children aged 6 and older in Britain.