There is now an authorized COVID-19 vaccine for younger teens, paving the way for immunizations to begin to reach a broader group of Americans at a time when the pace of vaccinations is slowing.
The Food and Drug Administration on Monday expanded the emergency-use authorization for BioNTech SE (NAS:BNTX) and Pfizer Inc.’s (NYS:PFE) COVID-19 vaccine to include 12- to 15-year-olds. Two days later a Centers for Disease Control and Prevention committee recommended using the vaccine in this age group, and on Wednesday CDC director Rochelle Walensky okay’ed the recommendation.
The vaccine was authorized for those 16 years old and older back in December, and more than 60 million people in the U.S. have since been vaccinated with the Pfizer vaccine, including at least 2 million 16- to 18-year-olds, according to CDC data .
It’s also the only COVID-19 vaccine that has been available for those 16 and 17 years old.
The shot demonstrated 100% efficacy in an ongoing placebo-controlled trial with 2,260 participants between the ages of 12 and 15 years old. (Moderna Inc. MRNA , which also has a two-dose, mRNA-based vaccine, said May 6 that initial data out of its study assessing the vaccine in 12 to 17-year-olds demonstrated 96% efficacy after one dose.)
The FDA said Monday that nothing is different in terms of dosing or spacing between doses for this new age group.
Over the past week, federal health officials all but said they anticipated that the EUA would be expanded to younger teens.
“We know that kids want to go to camp this summer,” Andy Slavitt, a senior adviser for the nation’s COVID-19 response, said Wednesday during a White House briefing on Wednesday. “We know parents want them to be safe. We know that parents prefer to have that done — if they want that done without masks, vaccinations are the best answer.”
“Over 15,000 local pharmacies will be ready to vaccinate 12 to 15-year-olds,” Jeff Zients, the White House’s COVID-19 response coordinator, said two days later. “And we are working to get more pediatricians and family doctors to offer vaccinations in their offices to make it as easy and convenient for adolescents to get vaccinated.”
Pediatricians say they are already fielding questions from parents who they say tend to be more concerned about the safety of immunizations for their children than themselves.
“A lot of parents take greater caution, asking more questions and wanting to have all the information at their fingertips and get the reassurances that they need, even if they’ve previously accepted or taken the vaccine themselves,” said Dr. Hina Talib, a pediatrician at The Children’s Hospital at Montefiore in New York City who specializes in adolescent medicine. “I think that that’s normal. I think that’s parenting defined.”
For teens, many of the questions have focused on when they are allowed to get the shots — “vaccine envy is real,” joked one pediatrician and mother of a 15-year-old — and if they need a parent to go with them (they do).
For parents of adolescents, the questions are slightly different. They want to know if the vaccine will impact teens if they are about to or are already going through puberty, including changes like weight gain or starting their periods, or if future fertility could be affected.
“There’s also a reason why we started with this age group,” Talib said. “It’s because their biology mirrors that of adults. And so when we enrolled children into trials, the strategy used was what we call age de-escalation.”
This means that the vaccines are being tested in order of seniority, so to speak. First, the vaccine makers enroll adults, then older teens, younger teens, and then much younger children. For instance, Pfizer is expected to share the first batches of clinical-trial data for 2 to 11-year-olds in September. For babies and toddlers, that data is likely to arrive in November.
For now, however, the goal is to start immunizing 12- to 15 year-olds, given that pediatric cases are rising in the U.S. The American Academy of Pediatrics said that the number of pediatric COVID-19 cases climbed 4% between April 15 and 29.
“Now we’re seeing the illness actually strike our younger, adult population because they’re still pretty much in the pipeline of getting vaccinated,” said Dr. Michelle Medina, a pediatrician and one of the leaders of the Cleveland Clinic’s vaccine steering committee. “And, in fact, we’re seeing a tremendous rise in pediatric COVID cases as well.”