“This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” said Moderna CEO Stéphane Bancel in a press release on Monday.
The trial—conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority—plans to enroll around 6,750 children in the United States and Canada to test the effectiveness and safety of the mRNA-1273 vaccine that is being given to adults around the world.
The Moderna vaccine is only authorized for use in adults 18 and older. But that may change as the company has begun testing its vaccine in the adolescent population aged 12 to 17, with the trial expected to complete in June 2022.
As for the pediatric study, it will be conducted in two parts.
The first involves assessing the dosage that will be determined for the second part of the trial. Children aged two to 11 will receive “one of two dose levels” of 50 micrograms or 100 micrograms, while those aged six months to two years will get one of three doses of 25 micrograms, 50 micrograms, or 100 micrograms.
The current two-dose series for adults is 100 micrograms each.
Part two of the study will then randomly assign other pediatric participants to get two doses of either a placebo saltwater solution or Moderna’s vaccine, 28 days apart. The children will be monitored for 12 months after the second shot to evaluate the effectiveness and safety of the vaccine.
Moderna says its “vaccine effectiveness will either be inferred through achieving a correlate of protection if established,” or comparing the participant’s immune responses to the “young adult (ages 18-25) population.”
A correlate of protection is the immune response needed for protection against disease or illness after vaccination or natural disease.
The pediatric study is estimated to end in June 2023.
Some people question the need for a vaccine for kids when studies have shown that children are less likely to become infected by the CCP (Chinese Communist Party) virus compared with adults. They are also less likely to spread the disease to adults.
When they are infected, however, most children will have mild symptoms or are asymptomatic, according to the Centers for Disease Control and Prevention (CDC).
According to the American Academy of Pediatrics (AAP) and the Children’s Hospital Association, children in the United States represent 13.2 percent of total COVID-19 cases as of March 15.
In addition, severe illness is rare and “the available data indicated that COVID-19-associated hospitalization and death is uncommon in children,” according to the AAP.
The mortality as reported in 43 states, New York City, Puerto Rico, and Guam for children was “zero percent to 0.19 percent of all COVID-19 deaths, and 10 states reported zero child deaths.”
According to a small longitudinal study published in Nature Communications, children may be experiencing milder COVID-19 symptoms or no symptoms at all because their innate immune system produces a high level of white blood cells called neutrophils that kill the CCP virus before infection of more cells can occur.
The innate immune system is the first line of defense against pathogens and other harmful substances that enter the body, while antibodies are produced later during the adaptive immune system.