Drug company Moderna has launched a study that will test its covid vaccine in children under 12 years of age, including six-month-old babies, the company said on Tuesday.
The study is expected to enroll 6,750 healthy children in the United States and Canada. Moderna declined to say how many had already signed up or got the first shot, according to spokeswoman Colin Hussein.
“There is a huge demand for children to find out about vaccinations and what they do,” said Dr. David Whale, medical director of the vaccine clinic at the University of North Carolina, who is not involved in the study.
In a separate study, Moderna is testing its vaccine in 3,000 children aged 12 to 17, and by summer it could have results for that age group. The vaccine should then be authorized for use in children, so it will not be immediately available.
Many parents want protection for their children, and vaccinating children should help develop herd immunity, which is crucial to preventing the epidemic. The American Academy of Pediatrics has called for the expansion of vaccine trials to include children.
The side effects of the vaccine, such as fever, throat surgery, fatigue and calf joints and muscles, can be more severe in children than in adults, and doctors say it is important for parents to know what to expect after inoculating their children.
In the Modern Study each child will receive two shots except for 28 days. The study will have two parts. In the first, children under 2 to 12 years of age may receive two doses of 50 or 100 micrograms. People under the age of 2 can receive two shots of 25, 50 or 100 micrograms.
In each group, the first children to be inoculated will receive the lowest dose and subsequent participants will be monitored for reactions before being given a higher dose.
After that, the researcher will perform an interim analysis to determine which dose is safe and probably protective for each age group.
Children in Part 2 of the study will receive the dose chosen by the analysis – or placebo shots with salt water.
Moderna developed its vaccine in collaboration with the National Allergy and Infectious Diseases. The company and the organization are also working together on the study, along with the Federal Biomedical Advanced Research and Development Authority.
Children will be followed for up to a year to see side effects and measure antibody levels, helping researchers determine if the vaccine provides protection. Antibody levels will be the main indicator, but researchers will also be able to detect coronavirus infections, with or without symptoms.
Dr Wohle said the study is likely to be well-designed and efficient, but he questioned why children would be followed for only one year, while adults would follow Modernna’s study for two years. He also said that even such small children are somewhat surprised when the vaccine is tested.
“Should we really learn what happens to older children before moving on to younger children?” Dr. Dr. Wohl asked. Most young children do not get very sick with covid, although they do develop some serious inflammatory syndrome that can be life-threatening, he said.
Johnson and Johnson have also said they will test their coronavirus vaccine in children and young children first in older children.
Pfizer-Bioentech is testing its vaccine in children aged 12 to 15, and has said it plans to move to smaller groups; The product is already authorized for use in the United States for 16 and more.
Last month, AstraZeneca began testing its vaccine in Britain on children 6 years and older.
