The drug company Moderna has started a study that will test its Covid vaccine in children under 12, including babies up to six months, the company said on Tuesday.
The study is expected to enroll 6,750 healthy children in the United States and Canada. According to a spokeswoman, Colleen Hussey, Moderna would not say how many had already reported or received the first shots.
“There is a big question to find out about vaccinating children and what they do,” said Dr. David Wohl, medical director of the vaccine clinic at the University of North Carolina, said, who is not involved in the study.
In a separate study, Moderna is testing the vaccine in 3,000 children aged 12 to 17 and may have results for the age group by summer. The vaccine must then be approved for use in children so that it is not immediately available.
Many parents want protection for their children, and vaccinating children should help bring about the herd immunity that is important in stopping the pandemic. The American Academy of Pediatrics has called for the expansion of vaccination trials to include children.
Vaccine side effects such as fever, sore arms, fatigue and pain in joints and muscles can be more intense in children than in adults, and according to doctors, it is important for parents to know what to expect after their children have been vaccinated.
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 be monitored for responses before the participants receive later doses.
Researchers will then perform an interim analysis to determine which dose is the safest and probably the most protective for each age group.
Children in Part 2 of the study received the doses selected by the analysis – or placebo shots consisting of saline.
Moderna has developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases. The company and the institute are also collaborating on the study with the federal biomedical research and development authority.
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The children will be followed for a year to look for side effects and measure antibody levels that can help researchers determine if the vaccine provides protection. The antibody surveys 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. Well. Most young children do not get very sick from Covid, although he has 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.