- The FDA approved a COVID-19 vaccine for younger adolescents, meaning children as young as 12 now have access to a COVID-19 vaccine.
- But parents of younger children may wonder when their child can get the vaccine.
- Vaccine studies for younger children are ongoing, with results possibly by early fall.
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Nearly half of people in the United States have received at least one dose of a COVID-19 vaccine, according to the Centers for Disease Control and Prevention (CDC), bringing the country closer to the end of the pandemic.
But a large segment of the population has yet to be vaccinated. Many of those are children and younger adolescents, who were not eligible to receive a COVID-19 vaccine.
Until this week.
On May 10, the Food and Drug Administration (FDA) expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents as young as 12 years old.
This development, along with the wide availability of vaccine doses in the United States, will help the country regain a sense of normalcy sooner.
“The more immunized children we have, the easier it is going to be for our communities to safely reopen, and to reopen schools and get after-school sports going again,” said Dr. Walter Dehority, an associate professor in the department of pediatrics at the University of New Mexico.
Other COVID-19 vaccines may be approved for younger adolescents over the next few months.
Younger children, though, will have to wait longer — possibly early fall or late in the year — because the studies for this age group are just getting up to speed.
Here’s a breakdown of where things stand with COVID-19 vaccines for children and adolescents.
Pfizer-BioNTech: Currently approved
On May 10, the FDA
This was based on data released by the companies in March showing that the vaccine had a high efficacy against symptomatic coronavirus infection in this age group.
The CDC’s vaccine advisory committee is scheduled to
Dr. Andi Shane, chief of the division of pediatric infectious diseases at Emory University School of Medicine, said May 11 in a Facebook Live event that the Pfizer-BioNTech vaccine should be available to 12- to 15-year-olds shortly after the CDC’s advisory committee makes its decision.
“Hopefully, Thursday morning the vaccines will start [for this age group], maybe even earlier than that,” she said.
In addition, “one of the advantages of electronic registration is that appointments can be made ahead of time, and many places are starting to do that now.”
Moderna-NIAID: Possible emergency use authorization by early summer
Moderna announced in an early analysis of phase 2 and 3 results that its clinical trial showed that the vaccine had an efficacy of 96 percent against symptomatic coronavirus infection in 12- to 17-year-olds.
The company has not said when it will submit an EUA application to the FDA for use of the vaccine in this age group.
This will depend on when the company submits the data to the FDA, and when the agency and the CDC review the results.
Johnson & Johnson (Janssen): Clinical trial in progress
The Johnson & Johnson COVID-19 vaccine has
The company expanded its vaccine trial in April to include 12- to 17-year-olds. The company has not announced when it expects to have results from this study.
Dehority, who is leading the Moderna pediatric COVID-19 vaccine trial at the University of New Mexico site, said vaccine trials in children and adolescents are similar in many ways to the adult studies, except for a few key differences.
“We have to have consent from the parents before children participate. Children that are old enough also have to provide their own assent to participate,” he said.
In addition, “we will often go a little bit slower with what we call ‘dose escalation studies,’ because children are not little adults,” he said. “We don’t know what dose [of vaccine] will work, so we’ll often start with lower doses and gradually work up until we find the appropriate level.”
Pfizer-BioNTech: Possible emergency use authorization by early fall
Pfizer is currently recruiting children 6 months to 11 years old for its pediatric vaccine study.
The company expects to seek an EUA for its vaccine for children ages 2 to 11 in September, it said during an earnings call in early May.
The exact timing will depend on how quickly the company can finish the study in this age group.
Moderna-NIAID: Possible emergency use authorization by early fall
Moderna is also recruiting children 6 months to 11 years old for its pediatric vaccine trial.
The company has not indicated when it will have results from this trial, but if it follows a similar timeline as Pfizer’s, the company could request an EUA for 2- to 11-year-olds by early fall.
Pfizer-BioNTech: Possible emergency use authorization by late 2021
Pfizer’s ongoing pediatric vaccine trial includes children 6 months to 2 years old.
The company expects to request an EUA for this age group during the final quarter of 2021, it said during its earnings call last week.
Again, this timeline may shift once the study gets further along.
Moderna-NIAID: Possible emergency authorization by late 2021
Moderna is also recruiting younger children for its pediatric vaccine trial.
The company hasn’t indicated when it will have results from this trial, but if it follows a similar timeline as Pfizer’s, the EUA request for this age group could happen late in the year.
As the vaccine trials in younger children move forward, pediatricians, parents, and public health officials eagerly await the results.
“It can’t be soon enough, from my standpoint, to see the vaccine move forward in the 12- to 15-year-olds,” said Dr. Evan Anderson, professor of medicine and pediatrics at Emory University School of Medicine, during the Facebook Live event.
“And we’re looking forward to having data to support being able to advance the vaccine for our younger children, as well, in the near future.”