Months after a call from the American Academy of Pediatrics to extend vaccination trials to all children, Moderna has officially begun a study that will test its COVID-19 vaccine in children under 12 years of age, which affects babies up to six months include.
Although 6,750 healthy children are expected to enroll in the United States and Canada, the drug company has not confirmed how many enrolled the first laptop.
Every baby and child in the study of Moderna gets two shots, 28 days apart. Unlike in adult studies, this experiment will be completed in two phases. In the first part, children between 2 years and 12 years receive two doses of 50 or 100 micrograms each. Babies and children younger than two years get two shots of 25, 50 or 100 micrograms.
“We give different doses to the children. It will get graded doses because we also have to determine which dose is best for the children.”
The first children vaccinated in this group will receive the lowest doses and be monitored for responses. Based on findings, participants will later receive higher doses. At this stage, researchers will conduct an analysis to determine which dose is the safest and probably the most protective for each age group.
Blood work – taken on the day of injection, one month after injection and five months after injection – will be taken to determine how children respond to confirm the appropriate doses.
Then begins the second phase of the trial, which allows children to receive the doses selected by the analysis or placebo recordings of saline.
“We give different doses to the children,” said Dr. Steve Plimpton, the lead investigator for the Moderna trial in children in Phoenix, said in an interview with NPR. “It will be graded doses, because we also have to determine the dose that is most effective for the children. So it starts with a smaller dose. It is still the same two-injection as adults but get different doses.”
According to Plimpton, the trial of Moderna for children would initially last 14 months, but he believes that the time frame could be shortened thanks to an overwhelming response from parents of potential participants.
“They look very ready,” he said. “They literally call all day to ask when they can get their children vaccinated … They seek protection for their children, but indirectly they will protect themselves and those around the children who may be infected if the children become really infected.
Related: The COVID-19 Vaccine and Children: What Parents Need to Know
Although this trial is good news for those who are eager to have a safe and effective COVID-19 vaccine that is approved for use in children, questions Dr. David Wohl, the medical director of the vaccination clinic at the University of North Carolina , its rapid timing.
Wohl – who is not involved in the Moderna study – said the trial looks well-designed and is likely to be effective, but asked why the children should only be followed for one year, while adults in the Moderna study for two years. long followed. He also has the New York Times he was surprised to see that the vaccine was being tested in children at such a young age.
“Should we first learn what happens to the older children before we go to the very young children?” he said.
Moderna currently has an ongoing clinical trial for 12- to 17-year-olds that began in mid-December. Pfizer-BioNTech is currently testing its vaccine in adolescents aged 12 to 15 and said it plans to enroll children aged 5 to 11 years later. Johnson & Johnson said they will only wait to test the coronavirus vaccine in infants and young children after it has first been tested in older children.