Walter, Sixteen Years, Nineteen Shot discussed on TIME's Top Stories
Don't get asked with cova older teens and adults do how these children's immune system's response to the virus and the vaccine remains a black box. The trial will also help. Provide some clarity on those questions visor. Bioenergy says it will test the same vaccine that is currently authorized for emergency use in the us for those sixteen years and older but this time in children aged six months to eleven years. The company is currently wrapping up. Study of its to dose shot in adolescence aged twelve to fifteen years in the us and europe. The latest pediatric trial will follow the same at three phased approach as adult study with phase. One involving one hundred forty. Four children aged five to eleven years at duke boston children's hospital. Cincinnati children's hospital and johns hopkins. Who will all receive the vaccine but be randomly assigned one of three dosages. If the vaccine is safe in this age group children aged two to four years will be tested and if safe in that group. The youngest children from six months to two years will get the vaccine. Depending on the immune responses these children generate the scientists adviser bio intech will make a decision about the safest and most effective dose with which to proceed in. Its face to face phase three studies. Those will include a total of about forty five hundred children. Broken down in the same age categories this time randomly assigned to receive either the vaccine or placebo in a two to one ratio. The results will be analyzed after six months to determine if the children receiving the vaccine both generated a stronger immune response than those getting placebo and that the response was on par with responses vaccinated adults. If that's the case then finds her bio intech will submit the data to the us food and drug administration to expand authorization to younger children and hopefully start vaccinating them by early next year. Dr manual walter professor of pediatrics and chief medical officer at the human vaccine institute who has overseeing the trial there says the study will answer important questions about the safety and dosing of the vaccine for children specifically whether younger children will need a different dose than adolescents and adults. The trial will test dose about one third that of the current adult dose another. That is about half the adult dose as well as the adult does while the pfizer bio tech covid. Nineteen shot is the. I m are innate technology based vaccine of any kind to gain fda authorization. Walter says it's likely to be safe in children. I don't think it's the platform so much that i would worry about for young children. I feel comfortable. Giving the ima- rene to young children. The questions of will they have side effects. Will the vaccine be tolerable to children and do. We need to use a smaller dose. In young kids are the biggest things so far. Walter says that they have seen an overwhelming response to the pediatric trial with parents. Like the gerardo expressing interest in enrolling their children both gerardo and his wife who is an infectious disease physician at duke are vaccinated and he says before his daughter is joined the trial they discussed volunteering with the girls. They understand that the results are going to impact other kids. And that's one of the lessons. We want to teach them with this experience. He says that this was one of the ways to contribute to help other people..