The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
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"We want this to happen before school starts. We want kids to go into the school year with this protection, especially our middle schoolers and high schoolers," said pediatrician Dr. Angela Moemeka, of Mark9 Pediatrics in Coppell.
Moemeka says she's making preparations in her own office to begin offering the vaccine to children once it's available, by developing protocols and adding staff to handle the needs required for administering the Pfizer vaccine.
She's also preparing for tough questions from parents who are apprehensive about vaccinating their children.
She said vaccinating this age group is a big step toward raising immunity levels across Texas.
Children make up a quarter of the state's population and just a few months ago, was the group that experienced the fastest rates of transmission.
"We know the safety profile because this has been given to thousands of children at this point. The trials have shown amazing efficacy. In terms of getting your kids 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 to recommend the shot for 12 to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.