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. According to a spokeswoman, Coleen Hussey, Modern refused to say how many people had already signed up or received the first shots.
“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 its vaccine in 3,000 children aged 12 to 17, and may have results for that age group Until summer. The vaccine will be authorized for use in children, so it will not be immediately available.
Many parents want protection for their children, and vaccinating children should help produce herd immunity, considered important to prevent the epidemic. American Academy of Pediatrics Has called for expansion of vaccine tests To include children.
Side effects of the vaccine such as fever, sore throat, tiredness and joint and muscle mass can be more acute in children than in adults, and doctors say it is important for parents to know that their children are vaccinated. What to expect after
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, the researchers will conduct an interim analysis to determine which dose is the safest and is likely to be protective for each age group.
In Part 2 of the study, children will receive the selected dose by analysis – or placebo shots containing salt water.
Modern developed its vaccine in association with the National Institute of Allergy and Infectious Diseases. The company and the institute are also working on the study in association with the Federal Biomedical Advanced Research and Development Authority.
Children will be followed for a year, to see side effects and to measure antibody levels which will help researchers determine whether the vaccine provides protection. 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.