- Pfizer and BioNTech are expected to ask the FDA for authorization to administer their COVID-19 vaccine to children under 5 years old.
- Children under 5 are the only age group in the U.S. with no access to a COVID-19 vaccine.
- According to reports, the vaccine could be available to young children by the end of February.
A two-dose pediatric COVID-19 vaccine could be available to children ages 6 months to 5 years as early as the end of February.
Pharmaceutical company Pfizer and its partner BioNTech announced on Feb. 1 that they have initiated a rolling submission of data to the Food and Drug Administration (FDA) to amend the current emergency use authorization (EUA) for their vaccine to include this younger age group.
Pfizer and BioNTech expect to complete the submission in the coming days.
Currently, children under age 5 are the only age group without access to a COVID-19 vaccine in the United States.
In a statement, the American Academy of Pediatrics (AAP) said they were encouraged by the news but would like to review the data.
“Pediatricians have seen firsthand the fear, stress and hardship that so many families of young children have endured as they await a vaccine,” AAP President Moira A. Szilagyi, MD, PhD, FAAP said in a statement. “We urge a transparent and data-driven process to evaluate this vaccine for this age group and look forward to offering its protection to our youngest children.”
The FDA’s vaccine advisory committee
This move comes “in response to the urgent public health need in this population,” Pfizer and BioNTech said in a news release.
They also indicated that the FDA had asked them to submit an application for the use of a two-dose pediatric vaccine, while they continue to research how well three doses work in this age group.
Data on a third dose would be submitted to the agency in the coming months, the companies said — with the expectation that the FDA would authorize a three-dose regimen for this age group if the data is favorable.
Dr. Steven Abelowitz, a pediatrician and regional medical director of Coastal Kids Pediatrics, said the Pfizer and BioNTech submission is “extremely significant for the well-being and safety of children during the pandemic… especially now with the rise in pediatric hospitalizations related to COVID.”
Over the past 2 years, more than 11.4 million children and teens have contracted the coronavirus that causes COVID-19, the AAP reported last week. Nearly 2 million of these cases occurred in the past 2 weeks.
While many children with a coronavirus infection have only mild infections, some can become sick enough to require hospitalization.
Overall hospitalizations among children and teens in the United States have eased in recent weeks, but they remain higher than at any other point in the pandemic, according to data from the Centers for Disease Control and Prevention (CDC).
In addition, some parts of the country are still reporting an increase in pediatric hospitalizations.
Some children who have had a coronavirus infection can also develop a serious inflammatory condition known as
“We’re currently seeing an increase in the number of MIS-C cases,” said Dr. John Bradley, an infectious disease specialist at Rady Children’s Hospital in San Diego.
“These are occurring about a month or so after the rise in pediatric COVID-19 cases that we saw after the holidays, which was expected,” he said.
The Pfizer-BioNTech COVID-19 vaccine has been found to reduce the risk of MIS-C in adolescents by
Bradley expects we will see a similar trend for younger children, although data for that age group is not yet available.
“We know from data in older kids that if you immunize children, you can prevent MIS-C,” he said. “And half the MIS-C is in school aged and preschool kids — including the younger kids who this vaccine is now targeting.”
In mid-December, Pfizer and BioNTech announced that two doses of their vaccine — which are given at 1/10 of the strength of the adult dosing — did not produce a robust enough immune response in children ages 2 to 4 years.
However, the immune response seen in children ages 6 to 24 months was similar to that of older teens and young adults.
There were no safety concerns in either of these younger age groups, according to the companies’ news release.
After the disappointing two-dose results, Pfizer and BioNTech extended their clinical trial to test a third dose, given at least 8 weeks after the second, in children 6 months to under 5 years to see if it improved the immune response.
Data on the third dose will not be available until at least late March, reported The Washington Post.
If the FDA had waited until then, a pediatric vaccine for younger children would not have been available until April.
Moving forward with a review of the two-dose regimen will allow parents to begin having their children vaccinated with two doses while the FDA waits for data on the three-dose regimen.
Given that there were no safety problems identified with the two-dose series, Bradley has no concerns with recommending that parents start their younger child on the vaccine soon after it receives FDA and CDC authorization.
“This is the kid’s vaccine, not just the adult vaccine that we’re giving to kids,” said Bradley. “The dose of the vaccine is designed to be lower to decrease the side effects.”
He said we also have safety data from millions of 5- to 11-year-olds in the United States who have received the pediatric COVID-19 vaccine.
“We now have more information on the safety of this vaccine for children at this point than we’ve ever had on any vaccine in the past,” he said.
In addition, “there is no reason to believe that the safety profile of the vaccine would be any different in a 2- to 4-year-old than in a 5- to 12-year-old.”
Bradley expects the FDA and CDC may take more time on authorizing the vaccine for children 6 to 24 months “to reassure us that the vaccine is just as safe for infants as it is for the older kids.”
If the agencies authorize the vaccine later this month, only a small number of parents may choose to have their younger child start on the two-dose regimen, with some waiting for the FDA to review the data on three doses and others waiting even longer.
Just under 20 percent of 5- to 11-year-olds are fully vaccinated, according to the AAP, with about 55 percent of 12- to 17-year-olds.
Dr. Andrea Anderson, associate chief of the division of family medicine at GW Medical Faculty Associates, said authorization of a pediatric COVID-19 vaccine for younger children would help more than just the child who gets vaccinated.
“Even though the number of children hospitalized in this age group is smaller, if a young child gets COVID it is challenging for all members of the family,” she said. “Parents and caregivers have to deal with the anxiety of caring for a sick child, as well as the economic impact of missed work.”