- Pfizer and BioNTech are expected to formally request emergency approval of their COVID-19 vaccine for children ages 5 to 11 in the coming weeks.
- The Pfizer-BioNTech vaccine is fully approved for people 16 and older and is available under emergency use for adolescents ages 12 to 15.
- Pfizer and BioNTech said last week that no serious side effects were found during the vaccine trial for 5- to 11-year-olds.
Today, Pfizer and BioNTech announced that they have submitted initial data to the Food and Drug Administration (FDA) from their COVID-19 vaccine trial in children ages 5 to 11.
The companies plan to formally request an emergency use authorization (EUA) of the vaccine for use in this age group in the coming weeks, they said in a statement.
The Pfizer-BioNTech vaccine is fully approved for people 16 and older and is available under an EUA for adolescents ages 12 to 15.
Last week, the companies released results from a phase 2 and 3 trial showing that the vaccine was safe and generated a “robust” immune response in children 5 to 11 years old.
This study included 2,268 children from the United States and several other countries. They received two doses of the vaccine around 21 days apart.
The dose used in the trial — 10 micrograms — is a third of that used for people 12 and older.
Researchers measured children’s immune response by looking at the level of neutralizing antibodies in their blood.
“These results — the first from a pivotal trial of any COVID-19 vaccine in this age group — were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 microgram doses,” the companies said in a statement.
They plan to submit the data from the full phase 3 trial to a scientific peer-reviewed publication.
Possible vaccine for kids by Halloween
Once the FDA has the full data from the phase 2 and 3 trial, FDA scientists will carefully review it.
After that, the FDA’s vaccine advisory committee is expected to meet and make a recommendation on whether the vaccine should be authorized for 5- to 11-year-olds.
Pfizer and BioNTech said last week that no serious side effects were found during the vaccine trial for this age group.
However, the FDA and its advisory committee will look for any potential concerns that the companies may have not identified.
One of these is heart inflammation — myocarditis and pericarditis — a side effect that has been seen in some young adults and teens after vaccination with an mRNA COVID-19 vaccine.
Most cases have occurred in young males after the second dose.
Dr. Christina Johns, pediatrician and senior medical adviser for PM Pediatrics, said it’s important to put the risk of heart inflammation into perspective.
“So far, the risk of myocarditis from COVID-19 infection in the older [adolescent] age group appears to be more significant than it is with the vaccine,” she said.
In addition, most cases of heart inflammation after vaccination have been mild, with people recovering quickly with treatment.
“Those [older] children have done well,” she said, “so I would anticipate that if we see this side effect in the younger age group, it would follow a similar course.”
If the FDA issues an EUA of the vaccine for this age group, the Centers for Disease Control and Prevention’s vaccine committee will meet to discuss whether to recommend its use.
If these reviews go smoothly, younger children could begin receiving doses around Halloween.
Results from Pfizer’s vaccine trial in children 6 months to 4 years are not expected until later this year at the earliest.
Results from Moderna’s pediatric trial are also expected around the same time.
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