It was a Monday morning surprise for families of children when they learned that COVID-19 vaccinations for their children might be available soon. A clinical study conducted by Pfizer and its German partner BioNTech revealed that the vaccination is effective and safe for children aged 5 to 11 when administered at a dosage that is one-third that of the dosage to teens and adults.
When Will The COVID Vaccine Be Available For Children?
Despite the fact that many parents, guardians, and caregivers are overjoyed by the news, others are concerned about what will happen next. Learn all you need to know about COVID-19 vaccination in young children, including what to anticipate and what it might imply for your everyday life in the United States. Read on for more information. What is the earliest possible time for children to get immunized?
In spite of the fact that some trial data has already been made available to the public, the FDA still requires a formal application with comprehensive data before the vaccine can be evaluated for emergency use authorization or EUA.
In an interview, Dr. Bill Gruber, executive vice president for vaccine clinical research and innovation at Pfizer, said that the firm expects to submit this data even by the end of the month. The submission of a formal EUA application, according to health experts, takes longer than the release of preliminary data because of the amount of documentation required. Nevertheless, after the data has been presented, the Food and Drug Administration and the Centers for Disease Prevention and Control will need to approve the vaccine before it can be made accessible to children.
According to Dr. Peter Marks of the Food and Drug Administration, approval is expected to occur within “a matter of weeks, not months” after application. According to him, the FDA is dedicated to processing the applications as soon as possible. “These pieces of information will not be left lying around.”
According to Dr. Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta and an associate professor of pediatrics and pharmaceutics at Emory University School of Medicine, vaccines for children ages 5 to 11 could be available in four to five weeks based on the adult as well as adolescent authorization process.
Such timeframes, though, he warned, are “a bit uncertain.” In his statement, he said that the FDA has the authority to seek more data from trial participants or monitor them for a longer time before reaching a determination. “At this point, it’s a bit premature to be making any firm predictions regarding timelines.” Is the vaccination dosage given to children as effective as the amount given to adults? Is it administered in two doses?
As an alternative, they looked at something called “immuno-bridging,” which evaluates the amount of immune reaction in children and compares it to the level of immune response in adults. A study including 2,268 participants ranging in age from 5 to 11 years revealed that they had the same kind of robust immune response to the vaccination as adolescents and young adults. Since Comirnaty, this vaccine’s brand name, has previously been shown to be successful in older populations, the vaccine’s manufacturers simply needed to demonstrate that the vaccination elicited a comparable immune reaction in children instead of demonstrating that the vaccine prevented COVID-19 infection.