According to research conducted by Pfizer-BioNTech, the COVID-19 vaccination is safe and efficacious for kids aged 5 to 11 when administered at a dosage that is one-third the amount used in teens and adults. In the midst of a nationwide outbreak of COVID-19 cases, many parents have already been anxiously anticipating a vaccination for their children, who’ve already returned to school. Since July, the number of cases of COVID-19 in youngsters has increased by about 240 percent.
Pfizer, Biontech’s Vaccine For Children (5-11), Shown Safe And Efficacious
Children are less likely than adults to get very sick as a result of COVID-19, but they may still contract and spread the virus, and they can sometimes develop a serious illness with long-term effects. Before the vaccine can be made accessible to children, it must be approved by the FDA and the Centers for Disease Prevention and Control. However, government authorities have pledged to examine the data as soon as possible after receiving it. Dr. Peter Marks of the Food and Drug Administration said that approval is expected to occur in “a matter of weeks, not months.”
The Comirnaty vaccine developed by Pfizer and BioNTech is now completely licensed for use in adults and pediatric patients. However, it is still only allowed for use in 12- to 15-year-olds in an emergency situation. As the company tracks the spread of the delta variant, which poses a significant threat to children’s health, Albert Bourla, Pfizer’s CEO and chairman said in a statement: “We are eager to extend the protection provided by the vaccine to this youth demographic, subject to regulatory authorization.” “These trial findings offer a solid basis for our application for licensure of our vaccination for children aged 5 to 11 years, and we want to submit it to the FDA as well as other regulatory agencies as soon as possible.”
When administered to adults, the Pfizer-BioNTech vaccine has a 30 microgram dosage, while the companies recommend a 10 microgram dose for children aged 5 to 11. Children would get the vaccine in two doses, each administered at least 3 weeks apart, just as adults would receive it. Following administration of this lower dosage, the vaccination is considered safe for youngsters, with the same kinds of mainly mild side effects as those seen by teenagers and young adults, as per the new findings.
In a prepared statement, Dr. Uur Ahin, CEO and co-founder of the BioNTech, stated, “Our goal was to produce and submit the data for school children to regulatory agencies across the globe before the winter season began.” A study including 2,268 participants ranging in age from 5 to 11 years revealed that they had the same kind of robust immune reaction to the vaccination as adolescents and young adults. Because Comirnaty has already been shown to be effective in older populations, the companies only needed to demonstrate that the vaccine elicited a similar immune reaction in children, rather than demonstrating that it prevented COVID-19 infectious diseases, which is why this study could be significantly smaller than that of the 44,000-person trial in adults.