Pharmaceutical company Modern has launched a study that will test its Kovid vaccine in children under 12, including children up to six months old, the company said on Tuesday.
The study is expected to enroll 6,750 healthy children in the United States and Canada.
“There is a great demand to vaccinate children and find out what it does,” said Dr. David Wohl, Medical Director of the Vaccine Clinic at the University of North Carolina.
In a separate study, Modern is testing his vaccine in 3,000 children aged 12 to 17 years.
Many parents want protection for their children, and vaccinating children should help produce herd immunity, considered important to prevent the epidemic. The American Academy of Pediatrics has called for an expansion of vaccine trials to include children.
In Modern’s study, each child would receive two shots 28 days apart. The study will have two parts. In the first, 2-year-olds under 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years of age may receive two shots of 25, 50 or 100 micrograms.
In each group, first children will receive the lowest dose vaccinated and later participants will be monitored for responses before being given a high dose.
Then, researchers will conduct an interim analysis to determine which dose is the safest and most effective for each age group.
In part two of the study, children will receive selected doses by analysis – or placebo shots that include saltwater.
Children will be followed for a year, to see side effects and to measure antibody levels which will help researchers determine if the vaccine is effective. Antibody levels will be the main indicator, but researchers will also look for coronovirus infection with or without symptoms.
Dr. Wohl said the study was well-designed and likely to be efficient, but questioned why children should be reared only for one year, when adults in Modern’s study were reared for two years goes. He also said that he was surprised to see this vaccine tested in children soon.
“Should We Really Learn in Older Children Before Going to Younger Children?” Dr. Wohl asked. Most young children are not very ill with Kovid, he said, although some develop severe inflammatory syndrome that can be life-threatening.
Johnson and johnson It also stated that it would test its coronovirus vaccine after infants and young children after the first test in older children.
Pfizer-BioNtech is testing its vaccine in children between the ages of 12 and 15, and has said it plans to go in small groups; The product is already authorized for use in those 16 and in the United States.
Last month, AstraZeneca began testing its vaccines in the UK for children 6 years and older.