The U.S. Food and Drug Administration is expected to approve Pfizer’s COVID-19 vaccine for youth by next week, according to a federal official and a person familiar with the process, and will give many a test before the start of the next school year. make an injection.
The announcement comes a month after the company discovered that the admission, which is already permitted for people 16 and older, also provided protection for the younger group.
Pfizer published preliminary results of a vaccine study of 2,260 American volunteers ages 12 to 15 in late March, which found that there were no cases of COVID-19 among fully vaccinated adolescents, compared with 18 among those who received sham injections.
Children had side effects similar to those seen in young adults, the company said. The main side effects are pain, fever, chills and fatigue, especially after the second dose. The study will continue to follow participants for two years to learn more about long-term protection and safety.
“We want this to happen before school starts. We want children with this protection to enter the school year, especially our high school and high school students,” said pediatrician Dr. Angela Moemeka from Mark9 Pediatrics in Coppell.
Moemeka says she is preparing in her own office to offer the vaccine to children as soon as it is available, developing protocols and adding staff to meet the needs needed to administer the Pfizer vaccine.
She also prepares for tough questions from parents concerned about vaccinating their children.
She said vaccinating this age group is a big step toward increasing immunity levels across Texas.
Children make up a quarter of the state population, and just a few months ago was the group that experienced the fastest transmission speeds.
“We know the safety profile because it has been given to thousands of children right now. The studies have shown amazing efficacy. To give your children the protection they need in the pandemic, this is the way to do it,” said Moemeka.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether the shot should be recommended for 12- to 15-year-olds. Shooting can begin after the Centers for Disease Control and Prevention adopt the committee’s recommendation. Those steps can be completed within days.