The rate of myocarditis in that particular group is “about 40 (cases) per million second doses of Covid-19 vaccine received,” he added. The risk for developing myocarditis is more commonly seen in men, particularly young men between the ages of 16 to 30, and typically after the administration of the second dose, Walter said. So it was examined for quite closely in the trial, and there were no cases,” he said. “If a child complained of any pain, chest pain, or shortness of breath, families were immediately called and children were evaluated. There were no cases of myocarditis in the children’s trial, Walter stressed, despite a careful evaluation of every possible symptom. Researchers do not know if younger children are at risk for myocarditis, but the study was careful to track any responses that might be warning signs. One safety concern has been the risk of myocarditis, an inflammation of the heart muscle and pericarditis, the inflammation around the heart, which has appeared occasionally in younger adults who received the vaccine. “Those things can be managed pretty easily with ibuprofen.”
“They may get a fever, they may feel a little achy, not feel as good the next day following vaccination, and that’s to be expected,” Walter said. He encouraged parents to prepare their children for an achy day after the shot.
That dosage was then administered in a larger trial of 4,500 children, of whom 3,000 were given the vaccine and 1,500 received a placebo.
The study determined that one-third of the adult dose, or 10 micrograms, produced an adequate immune response that was “best tolerated for children of that age, with the fewest side effects like fever, aches and chills and things like that,” Walter said. The clinical trial, which began in March, first investigated various reduced dosages of the Pfzier-BioNTech Covid-19 vaccine in children ages 5 to 11. Walter held a briefing Wednesday on the Duke trial, sharing an insider’s perspective on the scientific process. Emanuel “Chip” Walter Jr., chief medical officer of the Duke Human Vaccine Institute and professor of pediatrics at the Duke School of Medicine in Durham, North Carolina. One of those clinical trials was conducted by Dr. When a US Food and Drug Administration advisory committee recommended Tuesday that the agency grant emergency use authorization for Pfizer-BioNTech’s Covid-19 for children between the ages of 5 and 11, it was based on data gathered during clinical trials conducted around the United States. Side effects of Covid-19 shot in children ages 5 to 11 'mild,' investigator says Close Menu