Pfizer: Vaccine safe for children
Company reports shots work for 5-11 age group
Parents of elementary school students in the Houston area felt welcome relief on Monday when Pfizer announced its vaccine is safe and effective for the 5- to 11-year-old age group.
The findings represent a key step toward inoculating a younger population that so far is unprotected from the virus. Right now, only children 12 and older are eligible for a vaccine. Pfizer and BioNTech, the company’s German partner, next will apply for emergency use authorization with the U.S. Food and Drug Administration as health officials hope to have the shots ready by Halloween.
José García, a local father of two, said Monday he is pleased with the news. Worried that his 7-year-old daughter would catch COVID at school in Humble ISD, he enrolled her in the Pfizer vaccine trial at Texas Children’s Hospital this summer.
“It’s good to hear the studies are paying off,” he said. “We are happy to be part of the process to help other people get more trust in the vaccine, so we can start getting back to normal as soon as possible.”
Pfizer summarized the results released Monday from 2,268 trial participants. The findings show that children develop an antibody response similar to the 16- to 25-yearold age group when given one-third of the dosage. The child dosage also showed similar or fewer temporary side effects — such as sore arms, fever or aches — that teens experience, said Dr. Bill Gruber, a Pfizer senior vice president. He told the As
sociated Press that the company plans to apply for emergency use by the end of the month.
The study still is ongoing, and there haven’t yet been enough COVID cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.
García’s daughter is not included in the trial results released Monday. She received her first dose about three weeks ago and and her second dose on Monday. The family does not yet know whether she received the placebo. But the news makes García envision more family outings.
“We’re going to probably start traveling again,” he said.
In partnership with Baylor College of Medicine, Texas Children’s Hospital is among several U.S. health care providers participating in Pfizer’s pediatric vaccine trials.
Children younger than 5 are also receiving Pfizer’s trial vaccine at the hospital, but those studies are not as far along, said Dr. James Versalovic, the hospital’s interim pediatrician-in-chief. He hopes trials for 2- to 5-year-olds and 6-month- to 2-year-olds will wrap up by the end of the year.
Many Western countries so far have vaccinated people 12 and older only, awaiting evidence about proper dosages and safety. Cuba last week began immunizing children as young as 2 with its homegrown vaccines, and Chinese regulators have cleared two of its brands down to age 3.
Moderna’s pediatric vaccine trial is ongoing at Baylor College of Medicine. Moderna’s trials are normally about two to three months behind Pfizer but could speed up, depending on enrollment levels and results, Versalovic said.
“Vaccine trials do have to be tailored to children, because they are not little adults,” he said. “The dosing, the timing of these vaccines and the clinical environment are catered to children.”
While kids are at lower risk of severe illness or death than older people, more than 5 million U.S. children have tested positive for COVID-19 since the pandemic began, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant of the coronavirus swept through the country.
Monday’s announcement comes two weeks after pediatric COVID hospitalizations reached an all-time high in Texas at 345. That number dropped to 257 by Sunday but remains well above the pandemic’s earlier peaks.
Dr. Katelyn Jetelina, an epidemiologist at UTHealth School of Public Health in Dallas, said Monday’s news is a signal for parents to “hold tight.”
First, the FDA and the Centers for Disease Control and Prevention first must review the data in the emergency use application for approval, she said.
“Help is really on the way,” said Jetelina, who writes the the popular blog “Your Local Epidemiologist.” “There are a few steps that need to take place before it reaches kids’ arms.”
Still, Pfizer’s announcement comforted anxious parents.
“This is wonderful news,” said Stephanie Rubin, CEO of Texans Care for Children , a nonprofit that focuses on child health policy.
“As soon as the FDA gives the vaccine a thumbs-up for elementary school kids, I will be taking my son for a shot and reminding Texas parents that the best way to protect their kids is to get them vaccinated,” Rubin said. “Childhood vaccines are one of the greatest scientific achievements of the last century and will be critical to helping kids and families safely get back to so many of the things we’ve sacrificed over the last year and a half.”
In response to the news, two Houston mothers of elementary school children said they plan to vaccinate their kids as soon as possible.
Katy ISD parent Melissa Kelley said the same for her two children, ages 7 and 9, both of whom are taking virtual classes. She hesitates to send them to in-person class, where masks are not required, because she and her husband have health issues. She is not sure whether a vaccine will persuade her to send them back.
“I am concerned that not enough parents will vaccinate their kids at our school,” she said.
However, the vaccine will likely open more social opportunities for the kids.
“They only play outside with neighbors and friends, so we will be able to relax a little bit with that,” she said. “I just feel such a sense of relief and hope.”