The first children have been vaccinated in the pediatric trial Covid-19 phase 2/3 of Moderna, the company announced on Tuesday in a statement.
The clinical trial, called the KidCOVE study, will recruit approximately 6,750 children in the U.S. and Canada between the ages of 6 months and 11 years.
Duke Health spokeswoman Sarah Avery said they are not involved in the Modern trial. Representatives from UNC Health and Wake Research also told WRAL News that they are not participating in Modern Trials for Children.
Avery said the Duke trial of a Pfizer vaccine is expected to be extended to begin enrolling children ages 5 to 11 by the end of the month. Duke has been testing the Pfizer vaccine on children up to 12 years old since December.
Dr. Richard Chung, whose son participated in this trial, said he included about 2,000 participants.
Dr. Rachel Roper, a professor of biology and immunology at the University of East Carolina, said the vaccine is important in protecting children from the serious effects of COVID-19.
“A lot of people don’t think COVID can affect children, but it does,” Roper said. “Almost 7% of children receiving COVID are hospitalized, and of these, almost a third go to intensive care.”
She supports a strategy of gradually introducing small doses of vaccine and advancing trials in younger and younger children up to six months.
“Kids aren’t just young adults,” he said. “They have a different physiology. And then you also have to figure out what dose they need because they have smaller bodies.”
Moderna’s new essay follows this logic. It is divided into two parts. In the first part, different doses of the vaccine are being tested in children. Children between 6 months and 1 year of age will receive two doses of the vaccine spaced about 28 days apart at a level of 25 or 50 or 100 micrograms. Children between the ages of 2 and 11 will receive two doses of the vaccine about 28 days apart at a level of 50 or 100 micrograms.
The conclusions of the first part will be used to determine which dose will be used in the second part. For the second part, the trial will be expanded to include children who are given a saline placebo, which does nothing. Children will be followed for 12 months after their second injection.
Modern is testing to see if the vaccine protects children from getting sick if they come in contact with the coronavirus, according to the clinical trial patient information website.
“We are delighted to begin this phase 2/3 study on mRNA-1273 in healthy children in the United States and Canada,” Moderna CEO Stéphane Bancel said in a press release. “This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and the Biomedical Authority for Advanced Research and Development of the U.S. Department of Health and Human Services.
In December, the U.S. Food and Drug Administration authorized emergency use of the Modern Covid-19 vaccine for adults and the Povizer / BioNTech Covf-19 vaccine for people 16 years of age and older.
In February, the FDA authorized the emergency use of the Johnson & Johnson vaccine for adults over 18 years of age.