Pfizer-BioNTech COVID-19 vaccine Fully approved on Monday According to the Food and Drug Administration for people over the age of 16, it will take some time before it is approved for use in infants.
The Pfizer vaccine is available to children between the ages of 12 and 15 with an emergency use authorization. Before the emergency use authorization is extended to children under the age of 12 — this is expected this fall or winter, NBC News Report — You need to complete a clinical trial. Dr. Peter Marks, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, told reporters Monday, “Children aged 5 to 11 and then younger children.”
Both Pfizer and Modana are conducting vaccine trials in children to determine the right dose and whether it is safe and effective for young people. Pfizer CEO Albert Bourla told NBC News on Monday that he expects the study of children aged 5 to 11 to end in September and the data to be submitted to the FDA. Following the adult vaccine trial, the FDA requires two months of follow-up safety data, while for the child trial, the FDA requires four to six months of data.
The American Academy of Pediatrics said in a statement Monday that there were 180,000 new cases of COVID-19 between children and teenagers in the week ending last Thursday, and the organization told the FDA “Vaccines for Age”. Under 11 years old urging “actively work to authorize”. “