The announcement is expected to come a month after the company found that its shot, which is already licensed for those 16 and older, also offered protection to the younger group.
Pfizer released preliminary results from a vaccine study of 2,260 U.S. volunteers aged 12 to 15 in late March, showing there were no cases of COVID-19 among fully vaccinated adolescents, compared to 18 among those who received sham injections.
The children had side effects similar to those of 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 for more information on long-term protection and safety.
“We want this to happen before the start of the school year. We want children to enter the school year with this protection, especially our middle and high school students, ”said pediatrician Dr. Angela Moemeka, of Mark9 Pediatrics in Coppell.
Moemeka says she is preparing in her own office to begin offering the vaccine to children once it is available, developing protocols and adding staff to meet the needs necessary to administer the Pfizer vaccine.
She is also preparing to answer difficult questions from parents who are concerned about having their children vaccinated.
She said vaccinating this age group was a big step forward in increasing immunity levels across Texas.
Children make up a quarter of the state’s population, and just a few months ago, it was the group with the fastest rates of transmission.
“We know the safety profile because it has been given to thousands of children at this point. The tests have shown incredible effectiveness. When it comes to ensuring your children the protection they need during the pandemic, this is the way to do it, ”said Moemeka.
The FDA’s action will be followed by a meeting of a Federal Vaccine Advisory Committee to discuss whether to recommend the vaccine for 12 to 15 year olds. The shooting could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. These steps could be completed in a matter of days.