Months after a call from the American Academy of Pediatrics to expand vaccine testing to include all children, Moderna officially started a study that will test its COVID-19 vaccine on children under 12, which includes babies up to six months old.
Although this clinical trial is expected to enroll 6,750 healthy children in the United States and Canada, the pharmaceutical company has not confirmed how many have enrolled or received the first round of injections.
Each baby and child in the Moderna study will receive two vaccines, 28 days apart. Unlike adult studies, this trial will be completed in two phases. In the first part, children between 2 and 12 years old will receive two doses of 50 or 100 micrograms each. Babies and children under the age of two will receive two injections of 25, 50 or 100 micrograms.
“We are giving different doses to children. They will be gradual doses because we also need to determine the dose that is most effective for children.”
The first children inoculated in this group will receive the lowest doses and will be monitored for reactions. Based on the findings, later participants will receive higher doses. At this point, the researchers will do an analysis to determine which dose is safer and more likely to be protective for each age group.
A blood test – done on the day of the injection, one month after the injection and five months after the injection – will be done to determine how the children respond in order to confirm the appropriate dosages.
Then begins the second phase of the trial, which will allow children to receive the doses selected by the analysis, or injections of placebo salt water.
“We are giving children different doses,” said Dr. Steve Plimpton, the lead investigator for the Modern trial on children in Phoenix, in an interview with NPR. “They will be graduated doses because we also need to determine the most effective dose for children. So it starts with a lower dose. It is still the same two injections that adults receive, but in different doses.”
According to Plimpton, the Modern children’s trial was originally designed to last 14 months, but he believes that, thanks to an overwhelming response from the parents of potential participants, the time span may shorten.
“They look very ready,” he said. “They are literally calling all day asking when they can vaccinate their children … They are looking for protection for their children, but indirectly, they are also going to protect themselves and those around children who can be infected if children are really infected. . “
Related: The COVID-19 vaccine and children: what parents need to know
While this trial is good news for those who wish to have a safe and effective COVID-19 vaccine authorized for use in children, Dr. David Wohl, medical director of the vaccine clinic at the University of North Carolina, questions its rapid timing .
Wohl – who is not involved in the Moderna study – said the study seemed well planned and probably effective, but wondered why children should be followed for just one year, while adults in the Moderna study are followed for two years. He also told the New York Times he was surprised to see the vaccine being tested on children already so young.
“Should we first learn what happens to older children before we go to really young children?” he said.
Moderna currently has an ongoing clinical trial for young people aged 12 to 17, which began in mid-December. Pfizer-BioNTech is testing its vaccine on teenagers aged 12 to 15 and said it plans to enroll children aged 5 to 11 later this year. Johnson & Johnson said it would wait to test its coronavirus vaccine on babies and young children only after testing it first on older children.